SUPRASORB RANGE

RATIONALE AND EVIDENCE

A H - G






February 15, 2005














AC February 15, 2005 2
Contents page



1. SUPRASORB A 3

2. CLINICAL EVIDENCE OF ALGINATES 5

3. CONCLUSIONS ON ALGINATE DRESSINGS 8
3.1. Clinical Evidence gathered so far includes the following 8
3.2. Market Drivers for alginates are 8
3.3. Market Restraints for alginates are 8
3.4. Competitive Analysis 8
4. REFERENCES 10
5. SUPRASORB H 12

6. CLINICAL EVIDENCE ON HYDROCOLLOIDS 13

7. EXAMPLES OF HCD IN MORE DETAIL 15

8. CLINICAL POSITIONING 16

9. CONCLUSION ON HCD 18

10. REFERENCES 19

11. SUPRASORB G 22

12. CLINICAL EVIDENCE ON HYDROGELS 22

13. CONCLUSIONS ON AMORPHOUS GELS 24

14. REFERENCES 28





AC February 15, 2005 3

1. SUPRASORB A

Suprasorb A is a calcium alginate dressing, available as a wound sheet, for superficial
wounds and as wound filler for deep wounds. Both presentations may be used together or may
be combined.

Alginate dressings are developed from naturally occurring polysaccharides found in certain
species of brown seaweeds, harvested from western Scotland and the west coast of Ireland.
Alginic acid was first extracted from seaweed in 1881 by Stanford, a British chemist
1
. Calcium
alginates have been available as wound dressings since 1984
2
.
Alginic acid is a polymer of mannuronic and guluronic acid molecules. The two types of
alginate dressing that are generally available have differing proportions of these acid molecules
which belong to the group of sugar acids, respectively aldehydes or uronic acids
3,4
.

Both types of alginate react with exudate to form a gel at the surface of the wound by
exchanging calcium for sodium ions. Alginates contain different quantities of calcium and
sodium depending on the manufacturing process used.
Fibres absorb fluid from the wound by capillary action and a gel forms around the fibres. This
gel creates the moist warm environment as described by Winter
5
, which is hydrophilic and
allows relatively pain-free dressing changes
3
.

Alginate dressings have been shown to have properties such as, absorption of fluids up to
twenty times the products weight
3,4
.
The alginate fiber uses the principle of ion exchange; penetrated sodium ion replaces a calcium
ion. As long as this exchange process works, the fiber swells absorbing exudate, cell debris and
microorganisms
3,4
.
Alginate dressings that are high in mannuronic acid readily exchange calcium ions for sodium
ions. Fluid uptake by the dressing thus increases, forming a soft gel that can be easily washed
away with saline. Fibre dressings, high in guluronic acid, form stronger gels that keep their
shape, making removal in one piece possible.

To what extent the released calcium plays a positive role in the wound, is not yet known. In
principle it is suggested that calcium alginate dressings play a role in the different biological
processes such as, regulation of enzymes, release of hormones and neurotransmitters, muscle
contraction and cell proliferation
6-8
.
Alginate dressings facilitate an optimal environment for healing and are useful in the
management of exudate
9
. They have also been shown to be useful for haemostasis
10,11
.
Controlling of bleeding is suggested to occur when calcium ions are released into the wound,
activating platelets and some clotting factors, thereby promoting haemostasis
6
. Calcium
alginate forms a structural formula in which coagulation may occur better and faster and
wound exudate is absorbed and bound. Alginates with differing properties may be useful for
different wound types
6
.
When used appropriately, alginates facilitate trauma-free dressing removal and are
conformable and easy to use, with high levels of absorbency. The gelling action of alginate
dressings creates a warm moist environment that is ideal for wound healing and not painful
upon dressing change. Alginates are shown to reduce healing times when compared with other
types of dressing
10-13
. They are not suitable for use in dry ischaemic wounds
14
.
AC February 15, 2005 4
Fig. 1: Calcium alginate dressings, components, use and comments
Mean Components Use/comments
Alginate
(alginate dressings,
fibers polymer).


Calcium-alginate fibers,
respectively Calcium
sodium alginate fibers

Composed of parts of
brown seaweed
Manuronic, glucuronic
acid
- polysaccharides)

dressings and wound
fillers


Indication: Deep - and superficial-, moderately
exuding-, bleeding-, infected-, malodorous wounds
and cavities (e.g. leg ulcers, pressure ulcers,
donor sites).
May also be used in combination with wound gels.
Application: Fill the wound completely with the
alginate and cover with a secondary dressing
(gauze, film, hydrocolloid); The dressing may stay
in place 1-7 days, depending on exudate
production of the wound; in case of infection
dressing changes are to take place daily.

Advantages:
Haemostatic, high absorbent capacity (up till 20 times its own weight), forms a gel when in contact
with exudate or blood (exchange of Ca++/Na+- ions) optimal adaptation (for filling out of deep
wounds, respectively pressure ulcers) supports granulation formation; padding effect; easy to apply
(in combination with gauze or hydrocolloids films); hypoallergenic; well tolerated by patients; easy
to remove the saturated gel masse (with a tweezers or by rinsing) a- traumatic dressing change; also
absorbs slough, cell debris and microorganisms in the fiber-, gel structure; regulates moisture and
temperature.
May be well combined with fluids such as Ringers lactate, polyhexanide solution, etc.
If the wound bed is too dry apply 3-5 mm gel underneath the dressing.
Important:
The product is to be kept within the wound area and covered with a secondary dressing.

Typical calcium alginate products:

- Algosteril
- Algisite M
- Melgisorb
- Sorbsan
- Sorbalgon
- Suprasorb A
- Tegagen,

Typical calcium-sodium alginate product: - Kaltostat,


Typical calcium alginates with adjuvent
components:
- Curasorb ( +Zink )
- Sea Sorb soft ( + Cellulose )
- Trionic ( +Chlorophyll +Mangan +Zink )
- Urgosorb ( + Cellulose ),


AC February 15, 2005 5
2. CLINICAL EVIDENCE OF ALGINATES
Attwood
15
undertook a randomized controlled trial in patients with split skin graft donor site
wounds. In this study alginate dressings (Kaltostat) were found to accelerate wound healing
when compared with paraffin gauze. In the first phase of the study 15 patients had half of their
wound area dressed with Jelonet and the other half covered with an alginate dressing. It was
noted that the area dressed with alginate had healed significantly better than the part that was
covered with the paraffin gauze. The second phase of the study examined the standard time of
donor site wound healing and patient acceptability of the study dressing used. The dressings
were changed at day seven and again a significant improvement on wound healing and patient
comfort was noted. Patients reported less pain during wear time and at dressing change in the
wound areas, where the alginate dressing was used.
Gupta
16
et al. found that dressing changes were much less painful for patients when using
alginate dressings when compared with proflavine soaks. This was further supported by
Dawson et al
17
, who compared alginates with saline-soaked swabs. A lower bacterial count
was also noted by Gupta
16
using alginate dressings in postoperative surgical wounds.
Alginate dressings are often used in the treatment of pressure ulcers and Sayag et al
12

undertook a randomized controlled trial in elderly patients comparing the use of Algosteril
and Debrisan (dextranomer). Ulcers treated with the alginate dressing showed favourable
results when compared with those treated with dextranomer paste dressings
12
. The endpoint of
the study was a 40% reduction in wound surface area. This was achieved in 74% of the
alginate group and only 42% of the dextranomer group. The time taken to achieve this
reduction in wound surface area was reduced in the alginate group (P=0.000l), suggesting that
wounds heal quicker using alginates. This was a useful study in that the control and study
groups were well-matched in a large trial.
Foley and Allen
19
compared the use of alginate dressings and non-adherent dry dressings
postoperatively after toenail surgery. Results showed a reduction in healing time in the alginate
group of 22.7 days for total nail avulsion (P<0.05). Taking into consideration quicker healing
times, the alginate dressings, although more expensive per unit, were more cost-effective
overall. Several other studies have demonstrated faster healing times using alginates in
different wound types
12-19
.
Bale et al.
20
evaluated the use of an alginate dressing in the management of diabetic foot ulcers.
Their results showed a reduction in wound area over the course of the study, which compared
favourably with other studies in a systematic review
21
. Pain experienced by the patients was
less and peri-wound maceration decreased over the treatment period. Avoiding peri-wound
maceration is advantageous in the care of complex wounds, such as e.g. diabetic foot ulcers.
Belmin
13
and Sayag
12
cite pharmacological studies suggesting that alginates encapsulate
murine or human macrophages, which are activated and secrete cytokines. These, in turn, are
thought to stimulate autolytic debridement. Other invitro work suggests that alginates stimulate
the proliferation of fibroblasts and reduce the production of human microvascular endothelial
cells and keratinocytes
22
.
Bowler
23
investigated the infection control properties of alginates compared with a hydrofibre
and a hydrophobic dressing. In this study, two alginates successfully sequestered the bacteria
within the dressing; however, their ability to retain the bacteria in the dressing did not compare
AC February 15, 2005 6
favourably with the hydrofibre and hydrophobic dressings. Bowler and colleagues postulated
that although the rate of bacterial sequestration may be dependent on fluid-absorbing tendency,
the management of fluid within the dressing is more important.
Foster et al
24
conducted a randomized trial of 100 patients comparing the use of Aquacel and
Sorbsan in the treatment of a variety of surgical wounds healing by secondary intention.
They found that both dressings performed well in relation to minimal pain on removal of the
dressing, patient comfort, dressing application and removal, and that there was no statistical
difference between the two dressings in their performance.
Smith
25
explored the treatment of Sorbsan versus polynoxylin and Melolin dressings
following toenail removal, with 62 patients randomized to either treatment regime. Those
wounds dressed with the alginate dressing had a reduced median healing time and a reduced
number of follow up visits were required. The dressing also was easy to remove.
Retention of fluid in the dressing is relevant when the dressing is likely to be challenged by
plantar pressure in diabetic foot ulcers. Secondary dressing selection and frequency of dressing
changes should be carefully considered when using alginates on diabetic foot ulcers to
facilitate removal of contaminated fluid from the wound bed
26
.
Wounds that are dry or covered with a dry black eschar are not suitable for alginate
dressings
14
, as these dressings require exudate to activate the gelling process. Foster
25-27

highlight the importance of using alginates only on moderate to heavily exuding wounds, citing
instances of alginates drying out and traumatising adjoining tissues. In addition, Jones and
Milton
28
point out that moistening an alginate dressing affects the gelling process and limits
absorbency; this practice is therefore not recommended.
Following cleansing, the surrounding skin should be dried and the appropriate size of alginate
selected. The dressing should not overlap the wound margins
1
, as there is potential for lateral
wicking in alginates, which could lead to maceration
29
. If rope or ribbon versions are used,
these should be packed lightly into the wound; tight packing may cause unnecessary pressure
as the fibres swell when absorbing exudate. Several authors have discussed the use of alginates
in the treatment of a wound sinus and the potential problems of low levels of exudate causing a
plug and limiting drainage in the wound
30-34
.
Most alginate dressings require a secondary dressing. Selecting a suitable secondary dressing
will depend on the level of exudate. If low levels of exudate are expected, then a film dressing
may be required to maintain a moist environment. If high levels of exudate are expected, then a
more absorbent secondary dressing is required; this may be an absorbent pad or foam
3,29,34-37
.
If alginates with a high proportion of guluronic acid have been used, these maintain their
integrity and can usually be removed intact
28
. Residual fibres should be irrigated from the
wound surface and margins to prevent a build-up of fibres
33,34
.
Vanstraelen
32
also looked into the treatment of split skin graft donor site wounds, but
compared an alginate (Kaltostat) with porcine xenograft in 20 patients. It was found that the
wounds dressed with the alginate healed three days earlier and also had a good quality
regenerated skin. Alginates are often covered with film dressings.
33,34


AC February 15, 2005 7
The arrival of Aquacel has prompted studies comparing the use of this hydrofibre dressing and
alginate dressings. Armstrong and Ruckley
35
undertook a randomized controlled trial of 44
patients with leg ulcers, and found that there was a reduction in the number of dressing
changes required in the hydrofibre group, which meant a reduction in treatment costs due to a
longer wear time for the dressing. Russell and Carr
36
describe a case study of a patient with
foot ulcers where Aquacel was used. Although the patient was in a poor condition and died, it
had been noted that the number of dressings required were reduced and healing was promoted
in the wounds.

Alginates may be may be used for wound cleansing, even for infected wounds, up to the
granulation phase
36-40
. Traditionally, or in case of infection, the alginate is covered with sterile
gauze and fixed with surgical tape. The dressing may also be covered with a film, hydrocolloid
etc. (e.g. alginate wound filler covered with a hydrocolloid, respectively film), when there is no
infection present
1
.
The dressing change interval when a hydrocolloid dressing is used as a secondary dressing is
1-7 days. The dressing is to be changed, when the alginate is changed to a viscous gel, which
in itself remains stabile
1,3
. Normally the gel can be removed with tweezers, without difficulties
or the dressing may be gently released from the wound bed using 0,9% NaCl to make it
moist
1,3
.
There should be no concerns of leaving remains of the gel behind in the wound, which may
cause wound healing delay
4
.



Fig. 2: Features of Calcium Alginate Dressings
1,3
:

Advantages Disadvantages Indication Use

Hemostatic properties; high
absorbent capacity;
regulates moisture and
temperature; forms a gel,
therefore adaptation for e.g.
filling out of deep wounds;
supports granulation
formation; easy to apply;
hypoallergenic; well
tolerated by patients; easy
to remove providing a-
traumatic dressing changes.




Requires a
secondary
dressing for
fixation.

Deep - and
superficial-,
moderately exuding-,
bleeding-, infected-,
malodorous wounds
and cavities (e.g.
leg ulcers, pressure
ulcers, donor sites).

Fill the wound
completely with the
alginate and cover
with a secondary
dressing (gauze, film,
hydrocolloid); The
dressing may stay in
place 1-7 days,
depending on exudate
production of the
wound; in case of
infection dressing
changes are to take
place daily.




AC February 15, 2005 8
3. CONCLUSIONS ON ALGINATE DRESSINGS
Alginate dressings are positioned for moderate to highly exuding wounds and may be applied
to superficial and cavity wounds. A secondary dressing is required to cover the alginate, the
choice of secondary dressing is at the discretion of the clinician, depending on the wound
condition. Alginates can be used for infected and highly contaminated wounds. These
dressings are replacing the conventional gauze dressings for the acute as well as the problem
wounds, healing by secondary intention.
There are many dressings available to the clinician for use on wounds healing by secondary
intention.
3.1. Clinical Evidence gathered so far includes the following:
q Alginates have been shown to be of benefit in moderate to highly exuding wounds.
q The haemostatic properties of alginate dressings high in calcium may be useful in
arresting small bleeding points during sharp debridement.
q Alginate dressings high in mannuronic acid, which consequently form only a weak gel
on contact with exudate, may have a place in managing wounds with a sinus as they
are less likely to plug and can be flushed easily with saline.
q Alginate dressings are conformable and flexible, and because they also come in small
sizes, they are easily used on areas such as the foot, that are difficult to dress.
q Evidence from the literature suggests that alginates are not painful at dressing change,
and can reduce healing times.
3. 2. Market Drivers for alginates are:
q Favorable reimbursement level, which allows for daily dressing changes.
q Ease of use.
q Product innovation in the form of hybrid alginates with properties that enhance wound
healing.
3.3. Market Restraints for alginates are:
q The limited use of alginates in wounds with high levels of exudate only.
q Price pressure from an increasing number of competing alginate dressings in the
market.
q Cost-containment pressures.
q Limited innovation possibilities to augment the ease of use and efficacy of alginate
dressings.
3.4. Competitive Analysis:
There are over 21 marketers of Alginate dressings of which the top three players represent 78%
of the total market share. They are either well-established companies with products within each
dressing category or small companies with limited types of wound dressings. Competitive
factors include price, contracts and manufacturer reputation.
AC February 15, 2005 9

Alginate Dressing Market: Market Share Trends of Major Market Participants (U.S.)
1998-1999

Company 1999 (%) 98/99 Trend
Convatec 39 Down
Bertek 24 Down
Kendall 15 Up
Others 22 Up
Total 100

Other companies are:
3M, Bard, B. Braun/McGraw, BSN-Jobst, Carrington, Coloplast, Derma Sciences, DeRoyal,
Dumex, Ferris, Hollister, Johnson & Johnson, Medical Resources, Medline, MPM, and Smith
& Nephew, Hartmann-Conco Inc., Tycol/Kendall.

Note all figures are rounded; the base year is 1999
Source: Frost & Sullivan




AC February 15, 2005 10
4. REFERENCES
1) Gensheimer D A review of calcium alginates. Ostomy/Wound Management 39(l):34-
43:1993
2) Morgan D Alginate dressings. Journal of Tissue Viability 7(l): 4-14:1996
3) Andriessen, A, Huid en wondverzorging in: Leerboek intensive-care-verpleegkunde. Van
den Brink GTWJ, Lindsen F, Uffink Th (eds).Lemma BV Utrecht: 2003; 4th edition, Part
2, 25-105
4) Kammerlander G, Lokaltherapeutische Standards fr chronische Hautwunden. Wien; New
York: Springer, 1998 198 202
5) Winter GD Formation of scab and rate of epithelialisation of superficial wounds in the skin
of the young domestic pig. Nature 193: 293-4:1962
6) Thomas S Alginate dressings in surgery and wound management part I. Journal of Wound
Care 9(2): 56-60:2000
7) Oliver LC, Blaine G Haemostasis with absorbable alginates in neurosurgical practice.
British Journal of Surgery 37: 307-10:1950
8) Shotaro Harada et al. Clinical evaluation on Sorbsan (Calcium Alginate Dressing) for the
treatment of skin ulcers. J O Medicine and Pharmaceutical Science 10(2):473-495:1994
9) Pudner R Alginate and hydrofibre dressings in wound management. Journal of Community
Nursing 15(5): 38-42:2001
10) Kneafsey B, O'Shaughnessy, Condon KC The use of calcium alginate dressings in deep
hand burns. Burns 22(l): 40-3:1996
11) Harding KG, Jones V. Price P Topical treatment: which dressing to choose.
Diabetes/Metabolism Research and Reviews 16(Suppl I): S47-50:2000
12) Sayag MD, Meume S, Bohbot S Healing properties of calcium alginate dressings. Journal
of Wound Care 5(8): 357-62:1996
13) Belmin J, Meaume S, Rabus M, Bohbot S Sequential treatment with calcium alginate
dressings and hydrocolloid dressings accelerates pressure ulcer healing in older subjects: a
multicentre randomised trial of sequential versus non-sequential treatment with
hydrocolloid dressings alone. Journal of the American Geriatric Society 50 (February):
269-74:2002
14) Pudner R Alginate dressings. Practical Nursing 9(12): 18-20:1998
15) Attwood Al Calcium alginate dressing accelerates split skin graft donor site healing. British
journal of Plastic Surgery 42: 374-9:1989
16) Gupta R, Foster ME, Miller E. Calcium alginate in the management of acute surgical
wounds and abscesses. Journal of Tissue Viability 1(4): 115-16:1991
17) Dawson C, Armstrong M, Fulford S, Faruqi RM, Galland RB. Use of calcium alginate to
pack abscess cavities: a controlled clinical trial. Journal of the Royal College of Surgery of
Edinburgh 37(3): 177-9:1992
18) Royal Pharmaceutical Society British Pharmacopeia. Appendix: Wound dressings. Royal
Pharmaceutical Society, London, 1994
19) Foley GB, Allen J. Wound healing after toenail avulsion. A comparison of Kaltostat and
Melolin as postoperative dressings. The Foot 4: 88-91:1994
20) Bale S. Baker N, Crook H et al. Exploring the use of an alginate dressing for diabetic foot
ulcers. Journal of Wound Core 10(3): 81-4:2001
21) Cullum N, Najid M, O'Meara S, Sheldon T.Use of dressings: is there an evidence base? In:
Boulton AJM, Connor H, Cavanagh PR (Eds). The Foot In Diabetes. 3rd edn. Wiley,
Chichester: 153:2000
AC February 15, 2005 11
22) Doyle JW, Roth TP, Smith RM, Yi YQ, Dunn RM. Effects of calcium alginate on cellular
wound healing processes modeled in vitro. Journal of Biomedical Materials Research 32:
561-8:1996
23) Bowler PG, Jones SA, Davies BJ, Coyle E. Infection control properties of some wound
dressings. Journal of Wound Care 8(10): 499-502:1999
24) Foster, L., Moore, P., Clark, S. A comparison of hydrofibre and alginate dressings on open
acute surgical wounds, Journal of Wound Care 9; 9: 442-445:2000.
25) Smith, J. Comparing Sorbsan and polynoxylin/Melolin dressings after toenail removal.,
Journal of Wound Care 1; 3: 17-18:1992
26) Foster AVM, Greenhill MT, Edmonds ME. Comparing two dressings in the treatment of
diabetic foot ulcers. Journal of Wound Care 3(5): 224-8:1994
27) Foster, L., Moore, P. Acute surgical wound care 3: fitting the dressing to the wound,
British Journal of Nursing. 8; 4: 200- 210:1999.
28) Jones V, Milton T When and how to use alginates. Nursing Times 96(29): 2-3:2000
29) Moody M Calcium alginate: a dressing trial. Nursing Standard 13(Suppl): 3-6:1991
30) Butcher M Management of wound sinuses. Journal of Wound Care 8(9): 451-4:1999
31) Stansfield G Managing wound exudate in the diabetic foot ulcer. The Diabetic Foot 3(3):
93-8:2000
32) Vanstraelen, P.Comparison of calcium sodium alginate (Kaltostat) and porcine xenograft
(E-Z Derm) in the healing of split-thickness skin graft donor sites, Burns 18; 2: 145-
148:1992
33) Thomas S Alginate dressings in surgery and wound management: part 3. Journal of Wound
Care 9(4): 163-66:2000
34) Andriessen J, Wondbehandeling methodieken en middelen, Pharmaceutisch Weekblad
1991; 126 (3)
35) Armstrong, S., Ruckley, C. Use of a fibrous dressing in exuding leg ulcers, Journal of
Wound Care 6; 7: 322-324:1997
36) Russell, L., Carr, J. New hydrofibre and hydrocolloid dressings for chronic wounds,
Journal of Wound Care. 9; 4: 169-172:2000
37) Thomas, S. Alginate dressings in surgery and wound management-part 2, Journal of
Wound Care 9; 3: 115-119:2000
38) Timmons, J. Alginates and hydrofibre dressings, Professional Nurse 14; 7: 496-503:1999
39) Williams, C.Algosteril calcium alginate dressing for moderate/high exudate, British
Journal of Nursing 8; 5: 313-317:1999
40) Williams, C. An investigation of the benefits of Aquacel Hydrofibre wound dressing,
British Journal of Nursing 8; 10: 676- 680:1999


AC February 15, 2005 12
5. SUPRASORB H

Hydrocolloid (HCD) dressings consist of hydrophilic colloid particles (e.g.
carboxymethylcellulose) placed in a hydrophobic polymer matrix, with a semipermeable
polyurethane surface, not permeable to fluids and microorganisms
,1-15
.

Hydrocolloids have been around since early 1980. They are widely used for a variety of wound
types in different settings. Their limited absorbent capacity
1
is the reason why other absorbent
dressings, such as foams are increasing. Also hydrocolloids are occlusive adhesive dressings,
which make them less suitable for wounds at risk for infection, such as diabetic foot ulcers and
arterial wounds
1,6,9,11
. Most hydrocolloids disintegrate (form a gel) leading to malodor and
require more time upon dressing changes, as the wound needs to be cleansed. The gel they
form on the wound is sometimes wrongly identified as pus
1,2,6,11-39
.
In the beginning of the sixties in-vitro research was started on the application of HCDs. The
first known products were Varihesive (Duoderm) (Convatec) and later Comfeel (Coloplast).
Fig.1: Shows features of HCDs.



Fig. 1: Features of hydrocolloid dressings


Advantages


Disadvantages

Indication

Use/comments

Adhesive; absorption
(depending on thickness
and product), easy to
apply, flexible and easy
to mold, water resistant
(showering and a short
time bath are allowed)
stays in place for a
prolonged period of
time (up to 7 days,
depending on the
product and exudate
production), high wear
comfort, efficient
wound cleansing,
granulation and
epithelialization,
protects the newly
formed skin, additional
support as pressure ulcer
prophylaxis.


Not transparent
(except extra thin
version); malodor
may occur; the
dressing
disintegrates
when in contact
with the wound.
The adhesive
dressing is not to
be used on
sensitive skin,
such as in venous
leg ulcer patients.


Superficial and
deep, exuding
wounds and
cavities (deep
wounds should be
filled with wound
gel, alginates or
hydrofibers) for
wound cleansing,
granulation and
epithelialization as
well as protection
of epithelium with
thin skin. (Should
not be left in situ
for longer > 5-7
days).

The dressing is applied
3-5 cm overlapping the
wound edge; underneath
the HCD, wound gels
may be applied for dry-,
sloughy wounds, or
alginates, respectively
hydrofibers for heavily
exuding wounds, deep
wounds, as a wound
filler; during dressing
changes, wound
cleansing, using a
rinsing fluid, such as
saline.



AC February 15, 2005 13
6. CLINICAL EVIDENCE ON HYDROCOLLOIDS

HCD may be used for skin protection, such as for heels or other areas where friction may
occur. HDC may also be used under surgical tape, used for the approximation of wound edges
for delayed primary closure
6
.
According to Barnes hydrocolloids may provide some protection from shearing stress
56
.
However, they do not substantially reduce pressure to the wound area
56
. Consequently HCD
should be viewed as only one component of a total treatment protocol.

The beneficial healing effects of hydrocolloid dressings depend upon the interaction between
the dressing and exudate to create a moist healing environment
6
.
Use of hydrocolloids in dry wounds will not produce the healing effects outlined above and
more cost-effective options such as wound gels are available in these circumstances.

The risk of denuding new epithelium is more difficult to reduce than for alginate dressings as
the outer layer of hydrocolloids is resistant to soaking with sterile saline.
Use of hydrocolloids is therefore indicated for most moderately exuding wounds. However,
hydrocolloids are absorbent to a certain extent, the dressings do not cope well with heavily
exuding wounds and excessive exudate may tend to saturate the dressing.
In wet wounds exudate may spread beyond the wound edges and lead to maceration of the
surrounding skin
57
. Moreover the interaction between the dressing and exudate creates a
yellow, foul smelling and (occasionally) bloody discharge
56,58
. Saturation of dressings in
heavily exuding wounds and leakage of this discharge may significantly reduce patient
tolerance
56
.

As for all moist wound dressings, use of hydrocolloids is contraindicated for clinically infected
wounds. However, the presence of an unpleasant exudate should not be confused with clinical
infection
58
. Hydrocolloid dressings are opaque and should be changed infrequently.
Consequently, use is precluded in wounds with bone and tendon involvement due to the need
for close monitoring of such wounds
56
.

Use in diabetic patients
59
and in patients with ischemic ulcers is generally ill-advised
21
.
Allergic reactions have been observed for specific products; sensitivity to a dressing may be
due to the specific formulation of the inner layer of hydrocolloid material rather than to the
class of dressings. Hydrocolloid dressings are highly conformable to irregular wound surfaces
and are marketed as sheets, granules, pastes and powders
58
. The outer layer of these dressings
forms an effective barrier against water so that the patient may bathe normally and without
additional restriction
21,58
.

Dressing changes should be limited to facilitate the beneficial effects of the moist wound
environment and prevent undue disruption of granulation tissue and epidermal cell growth
58
.
However, care should be taken to prevent maceration. At a minimum, dressing changes should
occur once every 7 days but may be as frequent as every day for heavily exuding wounds
58
.

HCD as early moist wound healing products had to go against prejudices that under occlusion
an infection may develop. Hundreds of international studies and clinical case reports have
contributed that HCDs show marked progress in moist wound healing
7-55
.
Studies have shown that infection rates in wounds treated with occlusion are on average 2,6%,
versus 7,1% for conventional dressings, gauze, ointment or paraffin gauze
7
.

AC February 15, 2005 14
During an international forum for wound microbiology in Barcelona 1989, Hutchinson
7,19,20

presented the results of 103 studies performed on more than 7200 wounds, where 2,1% of the
wounds covered with an occlusive dressing were infected, versus 5,3% of the wounds covered
with conventional dressings
2
.
Of the 103 studies in 52 studies wounds were covered only with a HCD. When looking only at
the HCD group, the infection rate was 1,02% vs 4,01% infections in the group covered with
conventional dressings
1,2,19,20
.

Autolytic debridement uses the bodys own enzymes to dissolve necrotic tissue within the
wound. A moist environment accelerates the autolytic process
6,15
. Occlusive and semi-
occlusive dressings allow better contact between the necrotic debris and lysosomal enzymes in
the wound. Hydrocolloids, hydrogels, transparent films, and alginates are moist interactive
dressings that can be used for autolytic debridement
6,42
. This method is selective and causes
little or no pain. However, autolytic debridement may be slow
6
.

Wikblad & Anderson
33
compared the effectiveness of three types of wound dressings in
Swedish patients undergoing elective coronary bypass or valve replacement surgery. Seventy-
seven of the patients were randomized to an occlusive hydrocolloid dressing (DuoDerm) and
92 patients to a conventional absorbent dressing and 81 patients to a semi-occlusive dressing.
In the patients reported on (n=216) the incidence of wound infections requiring antibiotics was
5% (n=11). Of these infections, only 8 were found in sternum incisions; 5 of the 8 were in the
group of patients with absorbent dressings.

A study by Michie & Hugill
32
evaluated occlusive wound dressings (DuoDerm) in elective
plastic surgery. In this study the 40 wounds of 28 patients were randomized to one half the
incision covered with an occlusive dressing and the other half covered with an impregnated
gauze dressing.

A study comparing occlusive (Comfeel) with non-occlusive dressings by Holm et al 1998
31

was conducted in Denmark for which patients were selected with clean abdominal wounds
after surgical intervention. If patients developed a wound infection after surgery they were
withdrawn from the trial. These withdrawn patients' results were analyzed to provide infection
rates for the study. The outcome was beneficial for the study dressing.

Lansdown
30
evaluated silver coated HCD and reported some benefits, however there are still a
lot of unanswered questions as to the resorption and resistance of silver applied in this fashion.

AC February 15, 2005 15
7. EXAMPLES OF HCD IN MORE DETAIL

Duoderm CGF / Granuflex / Varihesive

Manufacturer: ConvaTec

Description: Improved formulation hydrocolloid dressing

Key Indications: Leg ulcers and pressure ulcers. As a primary dressing for burns,
donor sites and traumatic wounds.

Key Claims: Minimal leakage, long wear time, accelerated healing, and
improved comfort and convenience, cost effective, efficient
control of wound exudate.

Size Range: 10 x 10cm, 15 x 15cm, 15 x 20cm, 20 x 20cm, 20 x 30cm.

Related Dressings: Granuflex Bordered, Granuflex Extra thin

Comments: Granuflex (improved formulation) is a sterile hydrocolloid
dressing containing gelatin, pectin and sodium
carboxymethylcellulose
40
. The hydrocolloid has a top-film on its
outer surface, coated with a thin layer of foam. To date,
Granuflex is one of the most widely used dressings for chronic
wounds. It is waterproof and provides effective exudate
management.

Product Weaknesses:

q The dressing has very limited absorbency and fluid retention, even when compared to
other hydrocolloids
1,2,15,29-31
.

q Granuflex is relatively impermeable to vapor transpiration and as a result wound
exudate is simply trapped between the dressing and the skin.

q Un-retained fluid is prone to leakage, necessitating frequent dressing changes that
increase nursing time required and the number of dressings required per wound
1,2,15
.

q Odor, mess, patient discomfort and risk of bacterial penetration are significant clinical
issues
16-26
. This makes HCD less suitable for diabetic foot ulcers and other wounds at
risk for infection
26
.

q Creates a build up of back pressure caused by trapped fluid. This is particularly
undesirable on pressure ulcers where additional pressure on the wound should be
avoided
35
.




AC February 15, 2005 16

Comfeel Ulcer

Manufacturer: Coloplast

Description: Hydrocolloid dressing

Key Indications: Pressure ulcers, leg ulcers, burns, donor sites and minor injuries.

Key Claims: High flexibility and conformability, high cohesion, balanced
adhesion, water permeable, impermeable to bacteria, odor
proofing.

Size Range: 4 x 6cm, 10 x 10cm, 15 x 15cm, 20 x 20cm

Related Dressings: Comfeel Systems Plus, Plus Clear and Transparent

Comments: Comfeel consists of sodium carboxymethylcellulose particles
embedded into an adhesive elastic mass. A semi-permeable
polyurethane film covers the dressing.

Comfeel has strong adherence, pliability and clinical efficacy.

Product Weaknesses:

q Data
1
indicates that Comfeel is far less absorbent than foam dressings. This HCD was
tested against a standard - and an adhesive foam dressing (Smith & Nephew). The fluid
handling data indicates a failure for Comfeel to handle 23% of the delivered fluid. The
poor fluid handling ability of Comfeel, when compared with foam dressings, occurs as
a result of the dressings inadequate absorbency and permeability
1
.

q Risk of leakage due to poor fluid handling ability.

q Risk of maceration of surrounding skin due to the above weaknesses
41-49
.


8. CLINICAL POSITIONING

HCD are positioned for wound cleansing debridement support as well as for the support of
epithelialization. They may be classified as follows:

q type A only classical hydrocolloid (e.g. Hydrocoll, Suprasorb H, Tegasorb,
Varihesive,)
q type B mixed hydrocolloids (with alginate Comfeel plus) (with silver ions
Contreet H)
q type C combined hydrocolloids (with polyacrylate pad Combiderm)



AC February 15, 2005 17

Fig. 2: Hydrocolloids, composition, use and comments

Mean composition Use/comments

Hydrocolloid
Hydrocolloid
dressings

hydrophilic, colloidal
particles (e.g. Guar,
Karaya, Carboxy
methylcellulose, Gelatin,
pektin) inserted into a
hydrophobes polymer
stand (e.g. Polysobutylen
matrix) plus more or less
semipermeable PU
surface, not permeable
for liquids and germs
Advantages:
Adhesive (partly reinforced with an adhesive
border), high absorbent capacity (depending upon
thickness and product), easy to apply, flexible and
easy to mould, water resistant (shower and a short
bath is possible), prolonged time in situ (up to 7
days - depending on the product and amount of
exudate), comfortable, effective cleansing,
Granulation and epithelium stimulation, protection
of newly formed skin, additional aid to the pressure
ulcer prophylaxis Disadvantages:
Not transparent (except specially-thin and/or
transparent), it must be applied correctly

INDICATION:
Superficial and deep, not to moderately exuding wounds and wound cavities (fill deep wounds with
hydrofiber, gel or alginate), for wound cleansing, granulation and epithelialization as well as for
epithelium protection in case of thin skin; leg ulcers, pressure ulcers, all type of wounds (in case of
infection treatment with the hydrocolloid is to be discontinued, the wound is to be treated with an
antiseptic for a few days; with a timely start of topical antiseptic therapy, systemic antibiotic therapy
is often not necessary - Exception Diabetes patients), Split thickness skin grafts, abrasions, small
burns...

APPLICATION:
Apply the dressing with a 3 - 5 cm overlap to the wound edges; underneath the hydrocolloid a gel,
alginate or hydrofiber may be used for highly exuding, deep wounds as a filler - the effect of the
hydrocolloids is thus supported; with each dressing change particularly here accurate cleansing is to
be performed with wraps, rinsing or bathing as well as the dry phase which follows after cleansing;

IMPORTANT:
Extensive and deep, partly wet necroses should be removed surgically (faster, shorter therapy duration
and it is possible to observe the depth of the necrosis and condition of the wound bed).
Thick hydrocolloids as well as the special forms over the past years are replaced by foam dressings.
The thin, transparent and/or film-like hydrocolloids are still strongly represented (easy handling,
moldable , to be combined with wound fillers..)


Classical
hydrocolloids


Algoplaque, Algoplaque HP, Askina Biofilm S, Askina Biofilm Transparent,
Hydrocoll, Metoderm, NuDerm, Restore, Sure Skin, Suprasorb H, Tegasorb,
Traumasive, Varihesive - E, Varihesive extra thin, Varihesive E Border,...

hydrocolloid plus
alginate
combination

Comfeel Plus,


hydrocolloid plus
silver combination


Contreet H,


AC February 15, 2005 18
9. CONCLUSION ON HCD

Within the Exudate Management Market, the hydrocolloid sector is mature.
The market is still in a state of slow growth and has not yet reached a plateau, i.e. growth
estimated at 4%.
The reason why they are still growing is because, as home healthcare or alternative care
markets get on the moist wound healing band wagon they are being introduced to moist
wound healing with hydrocolloids, just like the hospitals were over 10 years. It has to be
remembered, that moist wound healing stated in the hospitals and that most of the KOLs come
from the hospital setting and alternative care is lagging far behind still.


Moreover hydrocolloids are still the most widely used dressing, in spite of its drawbacks.
Also, probably clinicians are starting with hydrocolloids because of cost. Absorbent dressings
are still more costly for the cash poor alternate market.

There are many competitor hydrocolloid products and profit margins are declining through
increased competition.
There are over 17 marketers of Hydrocolloid dressings world-wide of which the top three
represent a 70% market share. This is a mature market where companies are either well
established with products within each dressing category or small with limited types of wound
dressings. Competitive factors include price, contracts and manufacturer reputation.


Fig. 3: Hydrocolloid Dressing Market: Market Share Trends of Major Market
Participants (U.S.) 1998-1999

Company 1999 (%) 98/99 Trend
Convatec 60 Down
Smith & Nephew 7 Down
Coloplast 3 Up
Others 30 Up
Total 100

Note all figures are rounded; the base year is 1999
Source: Frost & Sullivan








AC February 15, 2005 19
10. REFERENCES

1) Shutler, S., Stock, J., Bales, S., Harding KG., A multi-centre comparison of a
Hydrocellular adhesive dressing and a Hydrocolloid dressing in the management of stage
2 & 3 pressure sores, Poster, 5th EWMA Conference 1995. CT89/16.
2) Solfest et al, A model to compare wear time of hydrocolloid dressings. Poster reprint.
16
th
Annual Clinnical Symposium on Advances in Skin and Wound Care. Orlando,
Fla;September 2001.
3) Aysan E, Ayar E, Baskent A, Eren Z, Tutuncu H. Outcomes of using transparent
hydrocolloid dressings versus dru gauze on surgical wounds. Advances in Skin &
Wound Care. 2001;March/April.
4) Xakellis GC, Chrischilles EA. Hydrocolloid versus saline-gauze dressing in treating
prussure ulcers: a cost-effectiveness analysis. Arch Phys Med rehabil. 1992;73(5);463.
5) ISO 14155. International Standard for Clinical Investigation of Medical Devices.
International Organisation for Standardization,1996.
6) Andriessen, A, Huid en wondverzorging in: Leerboek intensive-care-verpleegkunde.
Van den Brink GTWJ, Lindsen F, Uffink Th (eds).Lemma BV Utrecht: 2003; 4th
edition, Part 2, 25-105
7) Huchon D. Comparison between granuflex and paraffin-impregnated medical gauze in
the treatment of pressure sores. Going into the 90s: The Pharmacist and Wound Care.
Eurosciences Communication: 1992; France. 23-26.
8) Van der Cammen TJ, OCallaghan U and Whitefield M. Prevention of pressure sores. A
comparison of new and old pressure sore treatments. British Journal of Clinical Practice
1987;41:1009-11.
9) Bishop JB, Phillips LG, Mustoe TA, Van der Zee AJ, Wiersema L, Roach D, et al. A
prospective randomised evaluator-blinded trial of two potential wound healing agents
for the treatment of venous stasis ulcers. Journal of Vascular Surgery 1992;16:251-7.
10) Blair S, Backhouse C, Wright D, Riddle E and McCollum C. Do dressings influence
the healing of chronic venous ulcers? Phlebology 1988;3:129-34.
11) Gilchrist B and Reed C. The bacteriology of chronic venous ulcers treated with
occlusive hydrocolloid dressings. British Journal of Dermatology 1989;121:337-344.
12) Hermans MHE. Air exposure versus occlusion: merits and disadvantages of different
dressings.Journal of Wound Care 1993;2:362-5.
13) Gotzsche P, Liberati A, Torri V and Rossetti L. Beware of surrogate outcome
measures.
14) International Journal of Technology Assessment in Health Care 1996;12:238-246.
Prescription Cost Analysis data, England 1997. Department of Health, Government
Statistical Service Branch SD1E
15) Bradley M, Nelson A, et al. Dressings and topical agents used in the healing of chronic
wounds: a systematic review. NHS Centre for Reviews and Dissemination Report,
1998.
16) Lock PM. The effects of temperature on mitotic activity at the edge of experimental
wounds. In: Symposium on wound healing (Plastic, surgical & dermatological aspects)
Espoo, Finland A. Lingren & Sner A/B, Moiridat 1979: 103-108:1979.
17) Hofman D. The use of hydrocolloids, Nursing Times, 92(29), 64, 66, 68:1996
18) Hulten LDressings for surgical wounds, American Journal of Surgery,167(1A), 42S-
44S; discussion 44S-45S:1994
19) Hutchinson JJ McGuckin M. Occlusive dressings: a microbiologic and clinical review,
American Journal of Infection Control, 18(4), 257-68:1990
AC February 15, 2005 20
20) Hutchinson JJ Lawrence JC. Wound infection under occlusive dressings, J HospInfect,
17(2), 83-94:1991.
21) Kannon GA Garrett AB. Moist wound healing with occlusive dressings. A clinical
review, Dermatologic Surgery, 21(7), 583-90:1995.
22) Lawrence JC. Dressings and wound infection, Rn, 54(7), 10:1991
23) Lawrence JCDressings and wound infection, Am J Surg, 167(1A), 21S-24S:1994
24) Lotti T, Gasperini S Rodofili C. Should we use occlusive dressings in the treatment of
acute wounds?, International Journal of Dermatology, 36(2), 97-9:1997
25) Mertz PM, Marshall DA Eaglstein WH. Occlusive wound dressings to prevent bacterial
invasion and wound infection, Prof Nurse, 14(7), 496-9, 501, 503:1999
26) Schmitt M, Vergnes P, Canarelli JP, Gaillard S, Daoud S, Dodat H, Lascombes P,
Melin Y, Morisson-Lacombe G Revillon Y. Evaluation of a hydrocolloid dressing,
Journal of Wound Care, 5(9), 396-9:1996
27) Rasmussen H, Larsen MJ Skeie E. Surgical wound dressing in outpatient paediatric
surgery. A randomised study, Dan Med Bull, 40(2), 252-4:1993
28) Ryan TJ. Wound dressing, Dermatol Clin, 11(1), 207-13:1993
29) Pudner R. Hydrocolloid dressings. Practice Nursing 1998; 9: 17-19
30) Lansdown AB, Jensen K, Jensen MQ. Contreet Foam and Contreet Hydrocolloid: an
insight into two new silver-containing dressings. J Wound Care 2003; 12(6): 205-10.
31) Holm C, Petersen JS, Gronboek F Gottrup F. Effects of occlusive and conventional
gauze dressings on incisional healing after abdominal operations, European Journal of
Surgery, 164(3), 179-83:1998
32) Michie DD Hugill JV. Influence of occlusive and impregnated gauze dressings on
incisional healing: a prospective, randomized, controlled study, Annals of Plastic
Surgery, 32(1), 57-64:1994
33) Wikblad K Anderson B. A comparison of three wound dressings in patients undergoing
heart surgery, Nursing Research, 44(5), 312-6:1995.
34) Helfman T, Ovington L Falanga V. Occlusive dressings and wound healing, Clinics in
Dermatology, 12(1), 121-7:1994
35) Dealey C. Role of hydrocolloids in wound management, British Journal of Nursing,
2(7), 358, 360, 362 passim.1993
36) Eaglstein WH. Occlusive dressings, J Dermatol Surg Oncol, 19(8), 716-20:1993.
37) Field FK Kerstein MD. Overview of wound healing in a moist environment, American
Journal of Surgery, 167(1A), 2S-6S:1994.
38) Findlay D. Modern dressings: what to use, Aust Fam Physician, 23(5), 824-5, 828-9,
832-9:1994
39) Foster L Moore P. The application of a cellulose-based fibre dressing in surgical
wounds, J Wound Care, 6(10), 469-73:1997.
40) Heffernan A Martin AJ. A comparison of a modified form of Granuflex (Granuflex
Extra Thin) and a conventional dressing in the management of lacerations, abrasions
and minor operation wounds in an accident and emergency department, Journal of
Accident & Emergency Medicine, 11(4), 227-30:1994.
41) Hermans MH. Clinical benefit of a hydrocolloid dressing in closed surgical wounds,
Journal of et Nursing, 20(2), 68-72:1993.
42) Hermans MHE. An overview of physiological aspects of occlusive and nonocclusive
dressings... reprinted from Primary Intention, May 1995, New Zealand Practice
Nurse:1995
43) Hickerson WL, Kealey GP, Smith DJ, Jr. Thomson PD. A prospective comparison of a
new, synthetic donor site dressing versus an impregnated gauze dressing, J Burn Care
Rehabil, 15(4), 359-63: 1994
AC February 15, 2005 21
44) Bowler PG, Jones SA, Davies BJ Coyle E. Infection control properties of some
wound dressings, J Wound Care, 8(10), 499-502:1999
45) Kiernan M. Nurse prescriber. Wet, sloughy and necrotic wound management.
Community Nurs 1999;5(Pt 3):512.
46) Varghese MC, Balin AK, Carter DM, Caldwell D. Local environment of chronic
wounds under synthetic dressings. Arch Dermatol 1986;122:527.
47) Timmons J. (1994) Occlusive dressings reduce wound infection rates. Alginates and
hydrofibre dressings, Nurs RSA, 9(1), 12-3.
48) Wipke-Tevis DD Stotts NA. (1998) Effect of dressings on saphenous vein harvest
incision pain, distress and cosmetic result, Prog Cardiovasc Nurs, 13(3), 3-13.
49) Alsbjorn BF, Ovesen H Walther-Larsen S. Occlusive dressing versus petroleum gauze
on drainage wounds, Acta Chir Scand, 156(3), 211-3:1990.
50) Briggs M. Surgical wound pain: a trial of two treatments, J Wound Care,5(10), 456-
60:1996
51) Cannavo M, Fairbrother G, Owen D, Ingle J Lumley T. A comparison of dressings in
the management of surgical abdominal wounds, J Wound Care, 7(2), 57-62:1998
52) Chang H, Wind S Kerstein MD. Moist wound healing, Dermatology Nursing,8(3), 174-
6, 204:1996
53) Cho CY Lo JS. Dressing the part, Dermatologic Clinics, 16(1), 25-47:1998.
54) Dale J. Wound dressings, Prof Nurse, 12(12 Suppl), S12-4: (1997
55) Siegel DM, Sun DK Artman N. Surgical Pearl: a novel cost-effective approach to
wound closure and dressings, Journal of the American Academy of Dermatology,
34(4), 673-5:1996
56) Barnes HR 1993, Wound care: fact and fiction about hydrocolloid dressings, J
Gerontol Nurs, 19(6), 23-6.
57) Hansson C 1997, Interactive wound dressings: A practical guide to their use in older
patients, Drugs & Aging, 11(4): 271-284.
58) Choate CS 1994, Wound dressings. A comparison of classes and their principles of
use, J Am Podiatr Med Assoc, 84(9), 463-9.
59) Apelqvist J, Larsson J & Stenstrom A 1990, Topical treatment of necrotic foot ulcers
in diabetic patients: a comparative trial of DuoDerm and MeZinc, Br J Dermatol,
123(6): 787-92.
AC February 15, 2005 22
11. SUPRASORB G

The main components of the hydrogel dressing are sodium carboxymethylcellulose and
propylene glycol. The Suprasorb gel sheet has a polyurethane film carrier.
Hydrogels develop through expansion of macromolecular organic structures with water, which
are classified in the group of fluid rich hetero-gels. These wound gels are saturated with fluid
up to 92% and is therefore suitable for use in dry and black necrotic wounds
1-4,
.
Gels are used as donators of water and therefore are called watery polymer gels. A good
quality gel can bind the same amount of exudate, as the amount of gel put into the
wound
1-3,5
. Hydrogels may have a cooling and soothing effect and are therefore used in
radiation wounds and superficial burns
1
.
A modified Duhring Chamber test demonstrated Suprasorb G, amorphous and gel sheet to be
non-irritating for the skin
6
.

Features of hydrogel

Advantages Disadvantages Indication Use
Suitable for cleansing
and granulation
phase, especially if the
wound produces small
amounts of exudate;
the gel primarily
donates moisture to
the wound, but is also
able to absorb some
cell debris and wound
exudate
1-3,5
.
A secondary
dressing is
required (e.g.
foam dressings,
films, or
hydrocolloids)

1,2
.
Moisturizing of dry
slightly exuding
wounds, in order to
stimulate autolysis
and cellular
mechanisms.
Absorption and
binding of broken
down cell debris
and wound
exudate
1-3,5
.

Apply the gel in a layer of
3-5 mm into the wound, in
case of deep wounds the rest
of the wound is to be filled
out with foam or alginate; if
possible it is advised to
apply an occlusive dressing,
films, hydrocolloids etc.,
which enhances the
activity
1,2,5
. The dressing
can stay in place for 1-7
days; in case of infected
wounds dressing changes
should take place daily
1,2,5
.



12. CLINICAL EVIDENCE ON HYDROGELS
Hydrogels are reported to have benefits in providing selective, non-surgical debridement,
facilitating autolysis
7
.
The formulation of different wound gels results in a varying ability to donate water and absorb
fluid from the wound
8
.
The clinical experience of many individuals has suggested that such materials are useful in
clearing slough from wounds
9
, as well as providing/maintaining a beneficial moist wound
healing environment
10,11
.
Hydrogels exist both as sheet forms (e.g. Vigilon) and in amorphous forms (e.g. Intrasite,
Sterigel, etc. ). The amorphous hydrogels are reported to be more practical in terms of their
clinical application
1,2
. They may be applied for cavity wounds as a wound filler
12
, providing a
MWH environment and facilitating drainage

of wound exudate, pus and debris
1,2,12
.


AC February 15, 2005 23
Amorphous Hydrogels use and comments
1,2

Mean composition Use/comments

Classical hydro-gels, amorphous wound gels

Hydro-gel
Wound gel








Hydrophilic material
(e.g. modified starch,
carboxymethylcellulose
, propylen glygol,
calcium alginate) in
specific format


Advantages:
Effective for cleansing
11-13
and granulation
phase
1,2
, especially if the wound produces small
amounts of exudate; the gel primary donates
moisture to the wound, but is also able to absorb
cell debris and wound exudate
1,2,11-13
.
Disadvantages: A secondary dressing is required
(e.g. foam dressing, films, and hydrocolloid).



Application:
Apply the gel in a layer of 3-5 mm onto the wound, in case of deep wounds the rest of the wound is
to be filled with foam, alginate or hydrofiber; if possible additionally it is advised to apply an
occlusive dressing, films, hydrocolloids etc., enhancing the activity.
The dressing can stay in place for 1-7 days; in case of infected wounds dressing changes should take
place daily.
Important: extensive and deep, partly moist necrotic areas should be surgically removed.


Typical cellulose
gels
Intrasitgel, Normlgel,
Suprasorb G, Tegagel,
Varihesive Hydrogel,
Single use!
Cellulose gels with
adjuvant alginate
NuGel
Purilon Gel
Single use!

Hydro-gels/-Wound gels with anti-infection components

Cellulose gel with
polihexanide
Prontosan W Gel with
0,1% polihexanide
After opening the packaging, the product may be
kept for 6 weeks and is to be used for one patient
only.
Polyacrylate gel with
Hydrosomes,
Phospholipides, PVP
Repithel Gel with 3%
PVP-iodine
incorporated in
Phospholipid/
hydrosomes

After opening the packaging, the product may be
kept for 6 weeks and is to be used for one patient
only.
Specific action on fungi and bacteria reparative
characteristics at body cells






AC February 15, 2005 24
Hydro-gel/-Wound gel sheets use and comments
1,2

Mean composition Use/comments

Hydrogel
Hydrogel sheets

Hydrophile polymere
(e.g gelatin,
polyacrylamid polymere,
methacryl acid,
polyurethane,
polyethylenoid) + water
(water content depending
on the product is between
35%-96%), semi-
permeable polyurethane
surface, (most products)
Advantages:
Semitransparent surface, soft, comfortable,
refreshing, flexible (not as supple as
hydrocolloid sheets, hydro - polymer sheets, film
dressings); add moisture (for dry wounds)

Disadvantages:
A secondary dressing for fixation is necessary
(most products are without adhesive), moderate
absorbent capacity (depending upon water
content), Maceration of the peri-wound skin in case
of high levels of exudate, dries out (exception:
Products with
semipermeable surface); nowadays replaced by
hydrocolloids, foam sheets, films with e,g, gels as
wound filler


Indication:
Dry wounds, superficial injuries, split thickness skin grafts; wound surfaces with little exudate
production, Epithelialization phase;

Application:
Directly on the wound and peri-wound skin; additionally fix with secondary dressing; In situ on the
average days;

IMPORTANT:
Extensive necrotic surfaces, partly moist necroses should best be removed surgically (much faster,
shorter therapy duration and the removal of necrosis can be observed as well as the condition of the
wound underneath the necroses).

Gel sheets with
alcohol
Hydrosorb, Hydrosorb
plus, Opragel, Primamed,
Suprasorb G Gel sheet,
Spenco,...

Mostly replaced by hydrogels from the tube


Gel sheets without
alcohol

Geliperm, Interesting for eyelids (coma patients) or for
inflamed nipples for cooling and protection



13. CONCLUSIONS ON AMORPHOUS GELS
There are over 24 companies marketing amorphous gels. These companies are either well-
established companies with products within each dressing category or small companies with
limited types of wound dressings. Competitive factors include price, contract, and
manufacturer reputation.

AC February 15, 2005 25
Amorphous Hydrogel Dressing Market: Market Share Trends of Major Market
Participants (U.S.), 1998-1999

Company 1999 (%) 98/99 Trend
Carrrington 30 Stable
ConvaTec 20 Stable
Smith & Nephew 18 Up
Bard 12 Down
Others 20 Up
Total 100

Others include 3M, B.Braun/McGaw, Beiersdorf-Jobst, Brennen Medical, Coloplast,
Derma Sciences, Dumex Medical, Gentrell, Geritrex, Healthpoint, Hollister, Hyperion,
Johnson & Johnson, Kendall, Medi-Tech International, Medline, Molnlycke, MPM,
Sage, Southwest Technologies, and Swiss-American.

Note: all figures are rounded; the base year is 1999
Source: Frost & Sullivan
The Debridement Market:
If we look at the previous estimated 2002 market size in revenues for Gel Sheets, Amorphous
Gels and Enzymatic debriders, in the US market represents:
q $ 89.9 Million for Enzymatics (source: Kalorama)
q $ 32.2 Million for Hydrogel Sheets (source: Frost & Sullivan)
q $ 17.7 Million for Amorphous Gels (source: Frost & Sullivan)


Convatec, 20%
Bard, 12%
Smith &
Nephew, 18%
Carrington,
30%
Others, 20%
Amorphous Hydrogel Dressing Market

AC February 15, 2005 26
Depending on their positioning hydrogels may be seen as a debriding agent. Therefore it is
applicable to look at debriding agents as well as MWH dressings.

Data from Kalorama on the debridement market in general and enzymatic debriders in
particular seems not as specific as would be required.
IMS data on Enzymatic Debriding Agents (EDAs) seems more accurate. It offers global sales
of the top four EDAs:

Active Enzyme Brand Company Global
Marke
t Share
Sales U.S.
$ Millions
CAGR
1995-1999
Clostrideopeptidase
A (Collagenase)
Santy/Iruxol Smith &
Nephew
54% 58 1%
Deoxyribonuclease/
fibrinolysin
Elase/Fibrolan Warner
Lambert
27% 30 -16%
Papain Urea Accuzyme Healthpoint 14% 15 72%
Streptodornase Varidas Wyeth
Lederle
5% 6 -4%
EDA Total 109 -4%

Source: IMS Health 1999


This market, started to experience noticeable growth in 2000 with the transfer of Santyl
from Knoll to Smith and Nephew, who has now withdrawn with this product from the US
market, due to regulatory issues.
In addition, Healthpoints product continues to grow steadily.
Both Santyl and Elase are available globally, Accuzyme is only in the U.S. and the U.K.
and Varidase is only in Europe.

In terms of potential wounds that require debridement it is estimated that:


Proportion of cases requiring debridement
1

Pressure Ulcers 20%
Venous Leg Ulcers 27%
Diabetic Ulcers 53%



AC February 15, 2005 27
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