Anda di halaman 1dari 24

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

Abstracts from the book:

COLLAGENO E CICATRIZZAZIONE
realt e prospettive terapeutiche
F.Begh, M.Mian, B.Palmieri
Collagen and wound-healing present and future therapies
Collagen and wound healing International Congress

Istanbul March 1990

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

FOREWORD

In the listed clinical experiences and trials, the Euroresearchs collagen sponge
is mentioned other than as BIOPAD using different brand names and
trademarks merely for marketing purposes, amongst which Condress,
Gelfix, Proteita, and sometimes with laboratory codes BG PRG, EU 10102.
All these brand names (property of Euroresearch), identify the same collagen
sponge undergoing the same manufacturing process, in the same facility and
with the same identical composition and dosage.

EURORESEARCH s.r.l.
Via Larga 2 20122 Milan Italy
Ph + 3902 8055660 Fax + 39 02 72011722
www. euroresearch.it
info@euroresearch.it

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

INDEX
TITLE AND AUTHOR(S)
ROLE OF HETEROLOGOUS COLLAGEN
PROCESS OF WOUNDS IN RAT

Page
(CONDRESS) IN THE TISSUE REPAIR

M.Mian, R.Aloisi, S.Rosini, D.Benetti, R.Fantozzi

COLLAGEN IN COMPLEX LOSSES OF SUBSTANCE


S.Cussotti, M.Carli, M.Fasciolo, E.Cardesi, E.Teta

CLINICAL EXPERIENCE ON THE USE OF LYOPHILIZED COLLAGEN IN


GYNAECOLOGICAL SURGERY

S.Mancuso
THE REPAIR OF TRAUMATIC LESIONS OF THE SKIN MEDICATED WITH COLLAGEN
R.Rambaldi, A.Lazzerini

COLLAGEN IN ORTHOPEDY AND TRAUMATOLOGY


G.Soncini, E.Rinaldi

CLINICAL AND SURGICAL TESTS WITH COLLAGEN IN ORTHOPEDY


E.Tozzi, A.Zampieri, M.Benifei

TOPICAL COLLAGEN: RANK AND MECHANISMS


M.Mian. E.Mian

10

CLASSIFICATION OF VASCULAR ULCERS. TREATMENT OF VASCULAR ULCERS

11

WITH HETEROLOGOUS COLLAGEN

C.Corsi, S.Giordano
OUR EXPERIENCE IN THE TREATMENT OF TROPHIC LESIONS OF LOWER LIMBS

12

USING HETEROLOGOUS COLLAGEN

B. Borreani, L. Brizio, A. Mannari, F. Toniutti


CONSERVATIVE TREATMENT OF LEG ULCERS OF DIFFERENT ETIOLOGY.
CLINICAL COMPARISON BETWEEN HETEROLOGOUS LYOPHILIZED COLLAGEN AND

13

HYDROCOLLOID

L.Cangiotti,
G.A.Tiberio

A.Vinco,C.Codignola,

A.Coniglio,

P.Mujesan,

USE OF HETEROLOGOUS COLLAGEN (CONDRESS) IN THE TREATMENT OF

E.Teta,
14

MALLEOLAR ULCERS IN THALASSEMIC SUBJECTS

N.G.Cavallesco, G.F.Azzena, L. Lupi


THE USE OF COLLAGEN IN ANGIOSURGERY
G. de Donato, M. Placino, P. De Nicola

15

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

HETEROLOGOUS COLLAGEN IN THE TREATMENT OF SKIN TROPHIC LESIONS: OUR


EXPERIENCE

16

M.Giberto, R.Masini, G.Canova, P.Pramaggiore, M.A.Damerio, G.Becchi


PRELIMINARY CLINICAL DATA ON THE USE OF HETEROLOGOUS COLLAGEN IN

17

CONTINUALLY SOLUTION SKIN LESIONS

G.Ricotti, M.G.Tucci, A.Pugnaloni, M.M.Tappa, P.Schreiber, G.Biagini


TOPICAL THERAPY OF VENOUS ULCERS WITH HETEROLOGOUS COLLAGEN
R.Del Guercio, A.Niglio, R.Miranda, M.Del Guercio, G.Siciliano

18

OUR EXPERIENCE ON MORE THAN 2000 CASES OF ULCERS TREATED WITH

19

HETEROLOGOUS LYOPHILIZED COLLAGEN

B.Palmieri
THE TREATMENT WITH LYOPHILIZED COLLAGEN OF SKIN WOUNDS WITH LOSS

20

OF SUBSTANCE IN ON FIRST AID UNITS

G.Caselli , M.La Cava


TREATMENT WITH HETEROLOGOUS LYOPHILIZED COLLAGEN
THE LESIONS OF BEDRIDDEN PATIENTS

(CONDRESS) OF

21

G.Molinari
LYOPHILIZED

HETEROLOGOUS
COLLAGEN
DERMOSURGERY: RATIONAL AND RESULTS

AND

ITS

APPLICATION

IN

22

L.Verani, F.Begh, A.Zampieri

ONE CASE OF NECROSIS OF FOREFOOT


G.Etti di Rodeano

23

TOPICAL TREATMENT OF DIABETIC TROPHIC ULCERS USING HETEROLOGOUS


COLLAGEN (CONDRESS)
L.Granata, M.Caviglia, A.Battistini, G.L.Viviani, L.Adezati

23

THE USE OF MICROAUTOSKINGRAFTS IN THE TREATMENT OF WIDE PRESSURE


ULCERS: OUR EXPERIENCE
P.Ziccardi, G.Esposito, G.Di Caprio, M.Scioli and N.Scuderi

24

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

ROLE

OF HETEROLOGOUS COLLAGEN
REPAIR PROCESS OF WOUNDS IN RAT

(CONDRESS1)

IN THE TISSUE

M. Mian, R. Aloisi, S. Rosini, D. Benetti, R. Fantozzi*


Research Division Istituto Gentili, Pisa
* Pharmacology Institute - Ferrara University, Ferrara Italy
Abstract
The authors describe an experimental wound animal model to test the efficacy of
collagen sponge (Condress) in rats. Criteria evaluated were: 1) volume of exudate in
wounds, 2) number of granulocytes, 3) number of macrophages, 4) wound repair.
Collagen has shown a significant chemotactic effect in macrophages. The quantity of
exudate was higher in wounds treated with collagen sponge compared to control.
Collagen also showed a significant healing process compared to control.

COLLAGEN IN COMPLEX LOSSES OF SUBSTANCE


S.Cussotti, M.Carli, M.Fasciolo, E.Cardesi*, E.Teta**
Orthopaedics and Traumatologic Division Hospital Beato Umberto USL 36 - Avigliana (Torino)
* Dept. of Morbid Anatomy - P.O. Martini - US L 3 - Torino
** Clinical Research dept. Istituto Gentili - Pisa

Abstract
The authors were treating different types of chronic and acute wounds with collagen
sponges: 2 pressure ulcers, 3 post traumatic ulcers, 1 surgical wound dehiscence, 4
complex ulcers. Overall the collagen was able to improve the granulation tissue
formation in all the wounds treated and to accelerate the healing process, particularly
reducing complications such as exposed tendons.

1 CONDRESS is one of Euroresearchs proprietary trade marks used for marketing collagen pads. Other

Euroresearchs trade marks are BIOPAD, GELFIX, PROTEITA, all of them used to identify the same
identical collagen pad

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

CLINICAL

EXPERIENCE

ON

THE

USE

OF

LYOPHILIZED

COLLAGEN

IN

GYNAECOLOGICAL SURGERY
S.Mancuso
Obstetrics and gynaecology Clinical Institute - Catholic University of Sacro Cuore - Rome

ABSTRACT
In this study the author reports the results of his clinical experience by using collagen
sponge in some indications of gynaecological surgery.
A total of 204 patients were studied; they required conservative or destructive surgery
for several clinical indications.
Lyophilized collagen proved very handy, useful, safe, innocuous and efficacious in its
topical use in certain gynaecological indications.
In all the patients no variations of hemato-chemical tests took place, nor disturbances
immediately or after the post-operative phase.
The collagen soft sponges were applied and left in situ in the cavities created on the
myometrium context after enucleation of intramural nodes or uterine myoma.
Cicatrization was always satisfactory as shown by the clinical trend and the
echotomographic controls afterwards.
Whenever collagen was used as haemostat in the abdominal and vaginal
hysterectomies no side effects were observed and the clinical examination at
dismission and during follow-up never revealed infiltrations into the iliac fossae
indicating exuberant or retractive scars.
Of particular interest was the disappearance of urinary incontinence in almost all cases
of cysturethropexy. It is likely that collagen contributed to the consolidation of the
suburethral floor after Kellys plastic surgery, also when the muscular-membraneous
tissue was not particularly rich, making the operation more effective and the results
more satisfactory.
The few cases of dysuria reported, can be linked to the implant of the catheter in the
days after the operation, in particularly reactive patients.
We conclude therefore that the results obtained should suggest the use of lyophilized
collagen for above indications and possibly for wider applications and in other cases of
gynaecological surgery.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

THE REPAIR OF TRAUMATIC LESIONS OF THE SKIN MEDICATED WITH

COLLAGEN
R. Rambaldi, A. Lazzerini*
Division of Orthopaedics and Traumatology - Hospital of Melzo (Milan)
* Division of Orthopaedics and Traumatology, Ospedale S. Raffaele (Milan)

ABSTRACT
The authors were treating 27 patients, presenting skin lesions with loss of superficial
substance on the trunk (6 cases), on one of upper limbs (15 cases), on one of the
lower limbs (6 cases). The origin of the lesions was traumatic in 25 of the treated
cases, post-operative in the other two.
Wound debridement and cleansing were followed by the application on all the surface
of collagen soft sponges 5x5x0.5 cm. (CONDRESS), in sufficient number to cover the
loss of substance.
The medication with heterologous collagen was able to promote and accelerate the
tissue repair also in non-ideal situations (wounds not completely cleansed, irregular
edges, suspect secretion): the application of collagen stimulated granulation and
concurred in achieving the repair of the loss of substance.
In deep lesions the repair filled quickly the cavity, then tended to go above the
epidermal level with hypertrophic granulation tissue.
Compared to treatment with current medications, the loss of substance repaired in
shorter time. In cases where the comparison was possible (same subject, similar
lesions, depth and characteristics) collagen, compared to other medications as
described, filled faster the loss of substance. The medication with collagen, created
also a valid barrier to superficial infections. Although we never used antiseptic
treatment no superficial infection of the lesions took place.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

COLLAGEN IN ORTHOPEDY AND TRAUMATOLOGY


G. Soncini, E. Rinaldi
Orthopaedics and Traumatology Clinics Institute University of the Studies, Parma
Abstract
The authors were testing the efficacy of collagen in order to verify if its application
could accelerate or reduce cicatrization of lesions in orthopedics and traumatology
where there are several clinical situations requesting a fast cover of the skin and
optimum healing of tissue solution of continuity.
The collagen in form of soft sponges of different sizes or in form of films or as a
microfibrillate powder was, after wound detersion, applied every 3 days on the loss of
substance and fixed with gauzes and plasters. Both general and local tolerability were
evaluated with laboratory tests.
At the Orthopedic Clinic 59 patients were treated with the collagen sponges, some
hospitalized and some in casualty department. Out of these, 32 were periodically
followed until complete healing, 19 were males and 13 females, aged between 16 and
97 years (mean 55.5 years) affected by loss of soft tissue provoked by accidental
traumatic lesions (15 cases) or car accidents (13 cases). 4 patients presented leg
ulcers caused by obstructing vasculopathy.
The clinical results have been considered excellent in 15 cases having achieved
complete cover of the wound, good (14 cases) for a reduction of the surface of the
lesion and growth of granulation tissue, poor (3 cases) with an unchanged status of
the lesion. These last three cases were complex ones (one case of myelopathy with
sacral fistules, one paraplegia with ischial ulcers, one case with extremely large gluteal
decubitus and trochanteric ulcers).
The results achieved are considered highly positive considering the seriousness of the
lesions. The average application period of collagen was of 36 days (min. 10, max 87)
whereas the healing time was ranging between 10 and 113 days with an average of
43.
The use of collagen induced a significant improvement of the tissue repair process.
The sponge is handy, it is very well tolerated and never induced side effects.
The final results are more than satisfactory both for the time of healing (average 36
days) and for the quality of the scar.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

CLINICAL AND SURGICAL TESTS WITH COLLAGEN IN ORTHOPEDY


E. Tozzi, A. Zampieri*, M. Benifei
Orthopedics Division, USL 12, Pisa
* II Clinic, University of Pisa

ABSTRACT
The authors treated 18 patients, out of which 10 males and 8 females. Average age
was 56 years (22 to 73 years). 12 subjects were affected by sacral or on the heel
decubitus ulcers. They also treated a traumatic lesion of Achilles tendon with loss of
substance in the youngest subject and then the ulceration of a heel bursitis of the foot
and a lesion occurring on a scar after a popliteal cystectomy.
All these lesions were treated following the same protocol: at first, a surgical cleansing
removing from the edges the necrotic fragments, trying to avoid bleeding. Afterwards
Amuchina solution washes and patches were applied then carefully drying with sterile
gauzes the area treated. In suspect cases of infection a bacterial culture analysis of
fragments and exudates was performed to select the suitable antibiotic.
Once followed this protocol and made sure of a good detersion and sterilization of the
wound CONDRESS 5x5x0.5 cm was applied.
The obtained results were excellent on 78% of cases (14 patients) and good on 11%
of cases (2 patients): 2 patients were transferred to another hospital division before
the end of treatment and we could not evaluate them.
Healing time after the first application of CONDRESS varied between 8 and 30 days.
A granulation tissue grew very quickly which, evolving, determined an effective repair
process. No local or systemic intolerability phenomena took place.
Blood parameters did not considerably modify and in any case changes were not
correlated to the application of heterologous collagen.
At the end of their experience the authors were able to state that heterologous
collagen is certainly a valid and efficacious dressing, very well tolerated, that - if
applied according to a specific protocol - gives excellent and fast results in lesions of
small or medium entity, and in any case more than good in larger lesions where only
healing time is a little longer.
As far as the haemostatic function, this experience represents only a first approach,
showing a reduction in bleeding of 30-40%. This represents a starting point for further
experience on the use of CONDRESS during operation both alone or together with
bone transplants.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

10

TOPICAL COLLAGEN: RANK AND MECHANISMS


M. Mian, E. Mian*
Department of Pharmacology University of Milan
* Dermatologic Clinics - Pisa University

Abstract

The authors evaluated cases of continuity solution of the skin due to: ulcus cruris over
dermosclerotic angiodermitis (11), ulcus cruris permagnum with hypertrophic edges in
papillomatosis carcinoides (Gottron) (2), pyoderma gangrenosum terebrant (2), ulcus
cruris hypertonicum (Martorell) (4), ulcerous-crustic necrotic vasculitis (6), ulcerous
diabetic microangiopathies (7), severe phagedenic ulcers by decubitus (4), plantar
malum perforans chronically ulcerated (3).
On these ulcers the soft sponges of collagen were applied with a bandage poorly
compressive; the sponges were replaced2 whenever lysed.
The following parameters were evaluated:
1) quantitative evaluation of the covering speed
2) Photo evidence of the granulation tissue and of the edges of epithelialization
3) Sounding of skin microcirculation as to temperature and color
4) Histologic and histochemical structural evaluation of the granulation tissue. The
knowledge of these parameters was acquired mostly before the application of
CONDRESS. It was therefore possible a comparison per patient before and after
collagen application.
The effects recorded right after the collagen application were: activation of torpid
ulcero-necrotic focuses, absorbing/cleansing action (microbic barrier), planimetric
control of progression of repair of the edges, increase in neo-angiogenesis (with
thermographic and chromometric evaluation), lowering of pain. All the above effects
were significant if compared with previous situation of absence of repair process,
infection, ischemia, pain.
The ulcers considered were characterized by a very slow tissue repair process. The
cicatrisation index according to Lecompte de Nouy was in average at 0.09 (0.02-0.17)
in a substantial absence of repair during more than one month of observation. The
influence of CONDRESS was noted in the following 2-3 weeks of application. The
healing index increased to 0.82 (0.34-1.43) making ten times greater the repair
speed. This phenomenon was particularly evident in phagedenic decubitus and in
dermatosclerotic ulcus cruris, wellknown to be slow in repair.
In several cases the phenomenon occurred regularly.
The pain was constantly lowered in harmony with new blood circulation and repair of
tissues induced by collagen.

2 Note: By replacement it is intended that new sponges were added to those lysed. The sponges in fact
are NEVER detached nor removed from the lesions.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

11

CLASSIFICATION OF VASCULAR ULCERS. TREATMENT OF VASCULAR ULCERS


WITH HETEROLOGOUS COLLAGEN
C. Corsi, S. Giordano

Angiology Functional Unit Santa Chiara Hospital - Florence

Abstract
The authors made an extensive classification and description of different types of
ulcers.
The soft collagen sponge was applied after detersion and bacterial control of the
lesion, to exclude infection, and fixed with protective bandage (elastocompressive in
patients with venous pathology).
Ulcers were controlled every two days to observe possible lysis of the sponge which
was replaced partly or totally in case it resulted destroyed by lysosomial enzymes of
the granulation tissue cells.
In some cases antibiotic was administered locally, having noted that the sponge
retains the liquid without modifying the properties of the collagen (Fig. 9-10-11)
The healing of almost all venous ulcers was obtained, the fast improvement of the
ischemic and mixed ulcers was also achieved (tab. VIII).
In one case an infection from Gram-neg was noted; in the other two cases pain took
place after collagen application but there were no skin reactions from sensitization
such as erythema or edema.
The evaluation of the efficacy of collagen was made on the basis of clinical, objective
and subjective parameters.
Pain was evaluated, studying the characteristics, burning, paresthesia or itching.
Exudate, periulcerous erythema, edema, granulation tissue were also evaluated.
Based on our experience it can be stated that heterologous collagen represents a valid
drug for the therapy of ulcers of any origin. It showed particularly efficacious in
stimulating granulation process and induce re-epithelialization of the lesions.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

12

OUR

EXPERIENCE IN THE TREATMENT OF TROPHIC LESIONS OF LOWER

LIMBS USING HETEROLOGOUS COLLAGEN


B. Borreani, L. Brizio, A. Mannari, F. Toniutti

XIII U.S.L. GE-4 Division of Vascular Surgery


U.S.L. N. 3 Consultancies on Angiology and Vascular Surgery

Abstract
The Authors highlight the use of heterologous collagen Condress in the treatment of
trophic lesions of the leg.
The trial involved 30 patients of both sexes. The patients were subdivided based on
their systemic sickness in 3 categories:
- No 10 affected by mixed arterial and venous lesions
- No 5 affected by ischemic lesions
- No 15 affected by pure phlebostatic venous lesions
The patients were evaluated before starting the treatment by Doppler sonography and
in some cases with an angiographic examination in order to find a possible medical or
surgical indication to be performed besides the topical treatment of the lesion.
Before starting treatment, the detersion of the trophic lesion was made controlling the
same with culture pads and antibiogram.
The ischemic lesions improved leaving dry eschars which, when sometimes removed,
allowed the formation of granulation tissue.
Mixed lesions healed in 6 cases only; the remaining kept unchanged.
The venous phlebostatic lesions healed completely.
In conclusion, the collagen efficacy was demonstrated particularly when associated
with other medical or surgical therapies.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

13
CONSERVATIVE TREATMENT OF LEG ULCERS OF DIFFERENT ETIOLOGY.

CLINICAL

COMPARISON BETWEEN HETEROLOGOUS LYOPHILIZED COLLAGEN

AND HYDROCOLLOID
L.Cangiotti, A.Vinco, C.Codignola, A.Coniglio, P.Mujesan, E.Teta*, G.A.Tiberio
General Surgical Clinics and Surgical Therapy - University of Brescia
* Clinical Research Department Istituto Gentili, Pisa

Abstract
The study evaluated the therapeutical efficacy of collagen on healing of leg ulcers in
comparison with the efficacy of another preparation with different chemical
characteristics but with similar therapeutic indication.
At the Surgical Clinic of Brescia University 18 patients having leg ulcers (9 venous, 9
arterial or mixed) were treated.
After accurate topical detersion, heterologous collagen was applied as well as the
control product utilized on a control lesion, clinically comparable or on an equivalent
surface of the same lesion. Medical-surgical therapy of the basic disease (elastocompressive bandage, surgical revascularization, methabolic control) was associated
to the local topical therapy. Clinical controls were made at 7, 14, 28, 56 and 90 days).
The data obtained showed that once conditions of optimum detersion and sterilization
are reached, collagen induces a gradual reduction of the size of the ulcer.
The speed of this reduction resulted significantly higher as compared with the speed
obtained by the control product, independently from the origin of lesion (p<0.001) or
only considering the cases of venous ulcers (p<0.05).

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

14

USE

OF HETEROLOGOUS COLLAGEN

(CONDRESS3)

IN THE TREATMENT OF

MALLEOLAR ULCERS IN THALASSEMIC SUBJECTS


N.G.Cavallesco, G.F.Azzena, L. Lupi
Special Surgical Pathology Institute and Clinical Propaedeutics - University of Ferrara

Abstract
The authors observed 24 patients suffering of thalassemia and affected by malleolar
ulcers. These 24 patients, 14 males and 10 females, aged between 16 and 35 years,
were accurately studied clinically and physiopathologically.
The ulcer although always located at the malleolus showed a largely variable site
being on the medial or lateral district of one leg or of both. Based on the experience
made studying post-thrombotic syndrome, the patients were submitted to venous
pressure measurements. The first data gathered was a constant hypertension in
clinostatism min 5 mmHg, max 24 mmHg with an average of 15/20 mmHg.
Another important data was that hypertension in many cases was present also in the
other leg, in clinostatism, even in absence of the ulcer. In orthostatism the minimum
pressure was 2 mmHg and the maximum was of 6 mmHg with an average of 3.8
mmHg; furthermore the authors noticed in the orthodynamic test a complete absence
of pressure reduction in 8 patients, while in the remaining patients there was a
decrease of pressure with a curve clearly indicating a good emptying of the superficial
circle. Peculiarity of all recordings is the presence of a curve pulsating in synchrony
with the pulse, both in ortho and clinostatism.
Based on rheological modifications and venous hypertone recorded, a therapy was
established considering an elastic compression and the use of pentoxifilline which is
acting on the plasticity of red blood cells and on their deformability results in an
improved microcirculation.
To these two therapeutic devices, the use of heterologous collagen (CONDRESS) was
added for the last series of patients. The application of the product on ulcers is so easy
that the patient himself can apply it at home; the total absence of side effects and
mainly the speed of healing of the lesions, induced us to extend the use of collagen to
all patients under examination.
The feeling was that ulcers treated with collagen heal faster (on average a week
before) but what is most important is that all patients reached the complete closure of
the ulcer. Certainly there are still the obscure aspects of the ulcer pathogenesis in
thalassemic patients and the data obtained are sometimes not in accordance and of
difficult interpretation.
For sure the collagen strongly contributed to accelerate the healing of these lesions in
faster time and with very simple procedures with great satisfaction for the patient and
for the doctor.

3 CONDRESS is one of the several Euroresearchs proprietary trade marks (amongst which Biopad Gelfix

and Proteita) used to market the same collagen pad

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

15

THE USE OF COLLAGEN IN ANGIOSURGERY


G. de Donato, M. Placino, P. De Nicola

Ospedale Nuovo Pellegrini (New Hospital Pellegrini) - Angiosurgery and Cardiostimulation


Division - Naples

Abstract
Trophic lesions of lower limbs can be tied to venous factors (IVC - Post Phlebitic
Syndrome), to arterial (ACO) and dysmetabolic factors (diabetes mellitus). Cutaneous
hypoxiac sufference in IVC and PPS has its normal location at medial malleolus with
extension and conformation of the ulcer extremely variable. Localization as a sleeve
at the instep or on top of the foot or at lateral malleolus with multiple location are not
excluded.
The tissue repair process is due to the formation of bridges of collagen fibrils.
It appears therefore rational the topical use of collagen (CONDRESS4) to stimulate the
repair of the trophic lesion.
From October 1989 to February 1990, 23 patients were selected (10 males, 13
females), 49 years old on average (38-63 yeras). All were suffering from trophic
lesions on the legs, 6 of them from arterial origin (2 diabetic), 17 from insufficient
chronic venous flow. 18 patients had a simple trophic lesion, 3 a double lesion (venous
origin) 2 had multiple phlebostatic ulcers (3 in number).
Heterologous collagen has been used with positive results in preclinical tests on albin
rats after having induced a dorsal skin ulcer.
With the same product the concentration of plasmatic and local fibronectin was
monitored (on the lesion treated with CONDRESS). A large plasmatic reduction was
recorded and an increase in the site of the lesion, probably for a local binding
phenomenon.
Heterologous collagen appears therefore a useful substance to stimulate cicatrisation,
being a strong adsorbent of fibronectin that acts as a scaffolding.
CONDRESS can be applied directly on the bed of the wound, to act as a stimulator of
connective growth of granulation, of epithelial migration, as a selective filter for
bacteria and air, allowing oxygen exchanges as well as water steam from the bed of
the wound. During its absorption aminoacids and more complex molecules metabolize
in situ, therefore the properties of the compound can be considered fully physiologic.
At the control medications every 3 days a constant finding was the complete lysis of
the unit previously applied. One patient with a painful lesion healed already after 10
days.
The best results were recorded with the group of phlebopathics. In the subjects with
single lesion from IVC the healing took place for all the patients. Also patients with
double lesion healed completely at the control made at 56 days. In the group treated
with CONDRESS the healing occurred in all cases (3 patients) at the control at 14
days.
Based on our experience we believe that the use of heterologous collagen CONDRESS
is a valid support in the treatment of trophic lesions caused by bad vascularization,
once that preliminarily the correction of the cause has been performed.

CONDRESS is one of the several Euroresearchs proprietary trade marks (amongst which
Biopad, Gelfix and Proteita) used to market the same collagen sponge.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

16

HETEROLOGOUS

COLLAGEN IN THE TREATMENT OF SKIN TROPHIC LESIONS:

OUR EXPERIENCE
M.Giberto, R.Masini, G.Canova, P.Pramaggiore, M.A.Damerio, G.Becchi
General Surgery I Division Civil Hospital of Genoa Sampierdarena

Abstract
Skin trophic lesions are of high interest in surgery for their frequent occurrence and
for their relevant physio-pathological aspects, which quite often cause a difficult
correct interpretation and treatment.
The availability of a new device - lyophilized collagen soft sponges gave rise to a
high interest both in the scientific and in the clinical practice standpoints.
This innovative biological material, of natural origin, potentially has all characteristics
of an ideal dressing material; at the same time it results as the main mediator of the
tissue repair process. In fact, once extracted, heterologous lyophilized collagen
maintains unchanged the main chemical-physical characteristics of the natural
collagen as well as its efficacy.
The aim of this study was to evaluate the efficacy of the heterologous collagen in form
of a soft lyophilized sponge for healing of trophic lesions, treated for 4-6 months and
over with traditional devices without obtaining a complete cicatrisation.
Initially we included in this study 20 patients, during 6 months, presenting skin trophic
lesions of variable origin. Nine patients among them did not complete the study for
different reasons and were not considered in the evaluation of results.
The remaining 11 patients, 6 males and 5 females average age 69 5 years, in the
observation period August-November 1989, presented skin trophic lesions.
Seven out of the 11 patients treated healed completely (63.6%).
In 3 cases (27.2%) we obtained an improvement with incomplete healing after 120
days of treatment.
In 1 case (male, 71 years old, amputated of the right foot caused by obliterant chronic
arteriopathy, at the IV Fontaine degree) the conditions of the trophic lesions were
unchanged after 120 days owing to an additional recent bacterial infection. Once the
lesion was again sterilized it showed in the last control an improvement with partial
cicatrization of the ulcer but this case was considered not successful (9.09%).
On the contrary, the group treated with CONDRESS after 30 days of treatment showed
a progressive favourable evolution of the local state, achieving a maximum diameter
of the trophic ulcer of 1 cm after 120 days.
The data cannot but confirm the efficacy of heterologous collagen in promoting the
tissue repair process of skin trophic lesions particularly in cases of difficult healing.
The results of our studies confirm the efficacy of heterologous collagen in favouring
the healing process in case of trophic cutaneous lesions. Also in cases of difficult
healing the cicatrisation was successful in 63.6% of cases.
This datum joint to the one concerning the percentage of improved lesions (27.2%)
brings to 90.8% of positive results.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

17

PRELIMINARY

CLINICAL DATA ON THE USE OF HETEROLOGOUS COLLAGEN

IN CONTINUALLY SOLUTION SKIN LESIONS


G.Ricotti, M.G.Tucci, *A.Pugnaloni, M.M.Tappa, P.Schreiber, *G.Biagini
Clinical Dermatology
* Normal Human Morphology Institute - University of Ancona

Abstract
We compared the action of heterologous collagen with that of an hydrocolloid in the
repair of leg ulcers in vasculopathic patients and in the repair of donor's sites.
Our aim was to check the difference of healing time but also in quality of the tissue
repaired therefore besides the clinical study we also performed the histological study
in five cases of ulcers and the same was done on donor's sites. The latter was
performed to evaluate the tissue repair in areas not suffering vascular pathology.
Selection included both sexes, age between 15 and 80 years, in total absence of any
other pathology such to influence the tissue repair process. Therefore patients
underwent a general clinical and laboratory control before being admitted to the
study. Patients with crural ulcers were submitted to eco-doppler of legs. In patients
with two monolateral crural ulcers collagen was applied on the ulcer located more
distally; patients with large ulcers had the half ulcer proximal treated with
hydrocolloids and the half distal with collagen. In the two patients with donor's site,
the donor's site was treated half with collagen and half with a greasy gauze instead of
hydrocolloid. All ulcers were cleansed and disinfected. Sterilization of the lesions was
controlled by bacteriological analysis of the bottom of the ulcer. In patients who were
to be submitted to histological control a biopsy of the edges and of the bottom of the
ulcer was performed to evaluate the original conditions and to allow a comparison
once the treatment started.
After one month and after three months from treatment a biopsy was performed. Soft
sponges of collagen were applied in double and triple layer after being wet with
gentamycin and the biological medication was covered with a gauze.
The hydrocolloid was applied according to the usual directions of the product (granules
and adhesive pad).
Histological data show more clearly an exuberance of epithelium, larger regeneration
of connective, larger mesenchymal cellularity in the treated areas with collagen where
the layer of collagen fibers seems to have a more orderly distribution and where
phlogosis is lower.
It seems to us early to get anatomic-clinical conclusive considerations on the efficacy
of collagen in the tissue repair process generally speaking, but we believe to be able
to affirm that the selection of this material represents an advanced moment in the
repair process and and healing, even when is not faster, is certainly more
physiological.

EURORESEARCH s.r.l.

IST. ED. 1 Rev 1-MR1

18

TOPICAL THERAPY OF VENOUS ULCERS WITH HETEROLOGOUS COLLAGEN


R.Del Guercio, A.Niglio, R.Miranda, M.Del Guercio*, G.Siciliano
Chair and Department of Angiology - Medicine I - University of Naples
*Clinical Medicine and Nephrology Institute University of Naples

Abstract
A study on 20 patients with venous chronic leg ulcer was performed.
Patients were checked clinically, the aspect of the ulcer evaluated and size measured.
Detersion and sterilization of the ulcer was made before starting treatment and
repeated until the ulcer was no more polluted.
The evaluation of results after the repeated medications was made after 7, 30 and 60
days.
During this period of time it was recommended to patients to follow the hygienic rules
given according to the venous pathology present.
On all treated patients no local or generalized allergy occurred, showing the good
tolerability of the dressing.
Referring to the results, exception made for 2 cases, the other 18 cases resulted
positive. A complete disappearance of symptoms and a progressive reduction of the
ulcer was observed.
Collagen was largely tolerated by all patients. In all patients an efficient push to
cicatrization was obtained.
90% of cases (18 on 20) reached complete healing in a period of 60 days of
observation.
In particular 7 patients (35%) achieved healing within 30 days, 11 (or 55%) within 60
days.
In the two patients who after 60 days did not completely heal, the reduction of the
size of the ulcer was reached and they were expected to heal completely later on. No
patient suffered infections signs (sponges totally saturated by exudate) but for 20% of
them (14) after 2 days from application signs of favourable response of the vital
tissues (mixture of sponges with the bottom of the ulcer) were noted.
In the remaining 6 patients (30%) the sponges were unchanged after 2 days,
adhering to the bottom of the lesion and without macroscopic signs of favourable
response.
Non denaturated collagen is a wound healing dressing with high efficacy when
correctly applied. In particular the lesion must be cleansed and sufficiently sterile.
Excess of germ presence besides hindering or not allowing healing may provoke, due
to enzymes liberated by the germs the lysis of the collagen sponge with consequent
inefficacy of the same.
It can be concluded that the use of collagen to treat chronic phlebostatic ulcers, once
correctly made, is efficient, well tolerated, appreciated by patients also for the easy
way the medication is perfomed and the fast response to the treatment.

EURORESEARCH s.r.l.

OUR

EXPERIENCE ON MORE THAN

IST Ed.1 Rev. 1-MR1

2000

19

CASES OF ULCERS TREATED WITH

HETEROLOGOUS LYOPHILIZED COLLAGEN


B.Palmieri
Chair of Surgical Semeiotics - University of Modena
Abstract
The availability, in the last 15 years, of soft sponges of heterologous lyophilized
collagen allowed an increase its use also in consulting rooms for the treatment of
wounds and ulcers.
The clinical cases studied by the Authors include 2796 patients treated in consulting
rooms or hospitalized at the Clinica Chirurgica Istituto Policattedra from 1985 to 1989.
Globally 5 controlled studies for 112 patients were performed, comparing collagen with
gauze with dextranomer (72 cases) or hydrocolloid (40 cases).
The 72 cases were studied against control comparatively, while 40 cases were studied
by comparing in the same ulcer the adjuvant effect of collagen against hydrocolloid
splitting the area to be treated in 2 symmetrical semicircles and considering the
reduction of size by encroaching of the edges towards the center in both areas treated
with different compounds.
The control therapy without comparison product started only after an accurate surgical
detersion (with instruments home made and used for several years) or with a medical
cleansing treatment with dry gauzes and wrapper of low alkaline solutions.
In case of ischemic disease of legs, the treatment was performed together with
medical vasoactive therapies or revascularization whenever possible.
In cases of diffused arteriosclerosis, the application of collagen was anyway an
important therapeutic moment. In venous return pathology static and dynamic doppler
examination and phlebography were performed. Whenever xrays advised it, the
Lynton intervention was performed interrupting the insufficient vessels.
The treatment with collagen of venous ulcers has shown to be of therapeutic
importance: from one side in fact it has been possible to treat bleeding venous ulcers
in emergency taking advantage of the strong haemostatic effect of the product, on the
other side to induce faster a good granulation tissue.
In venous insufficiency a fixed compressive bandage, non removable, was applied
limiting the mobility of the patients for 5-10 days, during which the treatment was
optimized based on the time of dissolution of the product.
For decubitus ulcers the patients were mobilized every hour, the anti-decubitus
devices were used as well as a string bleeding detersion and drainage applied in the
most serious cases. Also exposition of ulcers to sun or ultraviolet rays to reduce the
microbial charge, was used.
Burns were treated with collagen opening to air the burned bottom of deep
teguments.
Actinic ulcers were the most torpid and those in which heterologous collagen had less
time to autolysis.
In diabetic foot the maximum effort was made to identify the microbial population
present (particularly staphylococcus aureus) and to compensate metabolism
administering insuline.

EURORESEARCH s.r.l.

IST Ed.1 Rev. 1-MR1

20

THE

TREATMENT WITH LYOPHILIZED COLLAGEN OF SKIN WOUNDS WITH

LOSS OF SUBSTANCE IN ON FIRST AID UNITS


G.Caselli , M.La Cava
Emergency Department, Hospital S. Giovanni - U.S.L. RM4 - Rome

Abstract
The aim of this study is to demonstrate the haemostatic and the healing effects of
CONDRESS.
The feature and the size of the wounds with loss of substance have been evaluated at
the moment of hospitalization and with subsequent clinical controls. The modalities for
a complete re-epithelialization were then put in evidence.
On November 1989 a random therapeutic trial started on patients of both sexes
arriving in our surgical First Aid Room with skin wounds with loss of substance.
The Authors favoured patients with rather large lesions or multiple lesions in regions
of easier evaluation exempt from vasculopathies, diabetes mellitus or other systemic
illnesses. This enabled to perform a more objective evaluation of lesions, the
utilization of a ground biologically homogeneous and moreover to treat in the same
patient part of the lesion with lyophilized collagen (CONDRESS) and another part with
paraffin gauzes.
Since November 1989 until January 1990, 31 male patients were treated (60.7%) and
20 females (39.3%) aged between 18 and 60 (avg. 39 years) arrived to the Surgical
First Aid Room with lesions with loss of substance.
A comparative study of the results collected every 3 days was performed and at the
beginning of treatment a fair or large reduction of 43 (84.3%) wounds treated with
Condress and 21 (41.1%) only of controls with a fair reduction was noted. On the 6th
day the results of treatment with Condress were confirmed as well as those of the
controls: 22 (43.1%) with fair, large reduction. On 9th day 42 (86.2%) wounds
treated with Condress (2 were healed) presented a fair or large reduction and 7
(14.3%) a moderate one, whereas about half of the controls, (26 = 50.9%), was in
fair or large reduction. On 12th day the results of treatment with Condress were
unchanged (85.7%) whereas in the wounds treated with paraffin gauze 12 only
(23.5%) were in fair or large reduction.
On 15th day we had 40 wounds treated with Condress (76.9%) and 46 with paraffin
gauze (90.1%). Out of the first ones 28 (70%) were in fair or large reduction; out of
the second ones 14 only (30.4%) were with fair reduction, the remaining with
moderate reduction.
This trend was confirmed in the long run so at 18th day only 32 wounds (62.7%)
were under treatment with Condress (the other 19 were healed) and 12 (37%) of
them presented a fair or large reduction.
The capacity of collagen to catch and maintain vital and active in the sites of lesions
the main cells of granulation tissue and its capacity to call from the edges of the
wound the cells of the germinative layer of epidermis, later connected to its deeper
fibers, constitutes the distinctive characteristics of CONDRESS compared with paraffin
gauze or other products.

EURORESEARCH s.r.l.

IST Ed.1 Rev. 1-MR1

21

TREATMENT

WITH HETEROLOGOUS LYOPHILIZED COLLAGEN

(CONDRESS5)

OF THE LESIONS OF BEDRIDDEN PATIENTS


G. MOLINARI

Ordine Ospedaliero San Giovanni di Dio Fatebenefratelli - "S. Raffaele Arcangelo" Hospital Long-term stay and Respiratory Rehabilitation Unit - Venice

Abstract
A serious and common complication of the immobilization of elderly people is
represented by the decubitus ulcer. A recent study outlined that after 20 days of
confinement in bed 7%-8% of decubitus ulcer appearance is detected; 50% of
patients developing ulcers are over 70.
In our case history 19 cases hospitalized in the ward for variuos pathologies of
bedridden patient have been treated with Condress. Out of the 19 cases, 6 for fracture
(femur, pelvis or rotula) 3 cases of diabetes, 3 pneumonia, 1 amputation of foot for
diabetic gangrene, 1 rheumatoid arthritis, 1 plastics for removal of epithelioma of the
leg, 1 angiodermitis of the right foot, 1 cardiac decompensation, 1 myeloma.
Three patients died for cardiac and lung complications: 1 after 48 days, 1 after 41, 1
after 30. The average age was of 79 years in the range of 54-93 years, mean of 82;
the females were 15 and the males 4. Treatment duration was from 30 days to a
maximum of 128 days with an average of 55.3 days. Nine cases healed (47.3%), six
gave a good response (31.5%), 4 scarce (21%); out of these latter two had sacral
lesions with the bone exposed, one died after 30 days of therapy.
Healing percentage in relation with the phase was:
phase 1: 1 case, one healing (100%)
phase 2: 8 cases, six healings (75%)
phase 3: 8 cases, three healings (37.5%)
phase 4: 2 cases, no healing
No side effects nor allergy were detected in any of the patients.
The percentages of scarce response (4) were as follows:
phase 1: 1 case, no scarce response
phase 2: 8 cases, no scarce response
phase 3: 8 cases, two scarce responses (25%)
phase 4: 2 cases, two scarce responses (100%)
At the conclusion of our experimentation we would like to state:
1) it is unquestionable the usefulness of Condress on ulcers regardless the
etiopathogenesis
2) it is necessary to intervene as soon as possible at the beginning of ulcer formation
because the good results are higher in the initial stage
3) anyway also in advanced stages of the ulcer better responses are obtainable with
Condress collagen as compared with other medications.
4) it is also to be noted the optimum tolerability and an absolute lack of general or
local side effects.

5 CONDRESS is one of the several Euroresearchs proprietary trade marks (amongst which Biopad Gelfix

and Proteita) used to market the same collagen pad

EURORESEARCH s.r.l.

IST Ed.1 Rev. 1-MR1

22

LYOPHILIZED

HETEROLOGOUS

COLLAGEN

AND

ITS

APPLICATION

IN

DERMOSURGERY: RATIONAL AND RESULTS

L. VERANI, F. BEGH*, A. ZAMPIERI**

Dermatology and IST Plastic Surgery Department, Genua


*Clinical Research Department Istituto Gentili, Pisa
**II Medicine - University of Pisa

Abstract
Transplants of skin and autologous grafts are techniques largely used in all those
circumstances, secondary to exeresis interventions, where an adequate reconstruction
is necessary. Sometimes anatomical causes and the elderly age of the patient, not
recommending long surgery interventions, make the application of these procedures
extremely difficult. The necessity to identify a substitute of fresh autologous tissue
characterized by high biocompatibility, induced us in this optics to evaluate the
possibility to use an heterologous lyophilized collagen available in soft sponges.
CONDRESS6, extracted from hinder tendons by a non denaturating process, is a type I
collagen maintaining its triple helix structure. Various studies confirmed its role as a
stimulating factor of the tissue repair process both in experimental models and in
various clinical conditions.
The aim of the study was to evaluate the efficacy of heterologous collagen as
substitute of autologous fresh tissues based on time of healing, quality of scar and
local tolerability.
116 patients were treated, 70 males and 46 females aged between 23 and 92 (mean
70 years).
78 patients were affected by basal and spinocellular epitheliomas.
The soft sponge of collagen was progressively digested by tissue collagenasis and
presented itself commisted or melted with the bottom of continuity solution. The next
sponge (or sponges) was applied on top of the previous one, whose debris were not
removed at the moment of medication.
The tissue repair process took place in optimal way in all the patients treated with
Condress. In particular no cheloids or hypertrophic scars were recorded and rare was
the sinking of the scar. Recovery time was similar to that observed in patients treated
with autologous implants or skin transplants. No local hypersensitization was
observed. Periodical bacteriological analyses of the lesions did not detect the
development of a bacterial flora potentially pathogenic and, as a confirmation thereof,
no infections were ever recorded.
Condress represents a valid alternative to autologous skin transplants and
transposition of edges in surgical dermatology particularly when these procedures are
difficult or when a reduction of the surgery time is required.
Based on our experience it can be stated that heterologous collagen has a role of
dressing and at the same time stimulates and optimally modulates the whole tissue
repair process and healing, whose stability was largely verified by prolonged follow-up
of these patients.

6 CONDRESS is one of the several Euroresearchs proprietary trade marks (amongst which Biopad Gelfix

and Proteita) used to market the same collagen pad

EURORESEARCH s.r.l.

IST Ed.1 Rev. 1-MR1

23

ONE CASE OF NECROSIS OF THE FOREFOOT


G.Etti di Rodeano

Civil Hospital Avezzano Plastic Surgery Unit

Abstract
This case involves a female, 65 years old, suffering from iatrogenic necrosis of
forefoot. The patient is diabetic, obese and arteriosclerotic.

TOPICAL TREATMENT OF DIABETIC TROPHIC ULCERS USING HETEROLOGOUS


COLLAGEN (CONDRESS7)
L.Granata, M.Caviglia, A.Battistini, G.L.Viviani, L.Adezati
General Medicine Clinics and Medical Therapy III Scientific Institute of Internal Medicine
University of Genoa

Abstract
Trophical ulcers of lower limbs represent a frequent outcome of diabetes mellitus and
often cause hospitalization.
Notwithstanding
the
multiple
etiology
(macroangiopathy,
microangiopathy,
neuropathy, phlebopathy) that requires complex systhemic therapies, the topical
treatment is necessary and consists in cleansing of the lesion and spur to cicatrisation.
In the absence of infections it is easy to reach the goal; however very often healing
shows a sluggish trend.
In these conditions the topical use of collagen represents an efficacious help
To evaluate the efficacy of collagen, the authors used it in three cases characterized
by trophic ulcers with torpid trend.
At the beginning of the treatment the ulcers were cleansed and sterile.
The collagen pad (Condress) was shaped at necessity, applied on the ulcer and
covered by a wet gauze and bandage to keep it on place.
Dressings were performed daily.
The ulcer was cleansed of essudates and collagen residuals using sterile saline.
In case of horny edges a surgical toilette was performed.
Condress proved to be very efficacious in promoting cicatrisation of cleansed trophic
ulcers.
During treatment no undesired side effects or allergic reactions took place.
The easiness of use make Condress suitable to the home use too, peculiarity very
important in case of long-term treatments.

7 CONDRESS is one of the several Euroresearchs proprietary trade marks (amongst which Biopad

Gelfix and Proteita) used to market the same collagen pad

EURORESEARCH s.r.l.

IST Ed.1 Rev. 1-MR1

24

THE

MICROAUTOSKINGRAFTS
PRESSURE ULCERS: OUR EXPERIENCE
USE

OF

IN

THE

TREATMENT

OF

WIDE

P.Ziccardi, G.Esposito, G.Di Caprio, M.Scioli and N.Scuderi*


Foundation Labour Clinics.
Morphofunctional rehabilitation Section in Plastics Surgery Unit.
Medical Centre Campoli M.T.-I.R.C.S.S. (Benevento Italy)
* Plastics Surgery Chair University La Sapienza, Rome

Abstract
The surgical treatment of wide pressure ulcers is generally performed using nearby
edges or myocutaneous skin. Unfortunately it is not always possible to treat these
patients that are generally very run down and in very poor general conditions.
The skingraft too can be performed on pressure ulcers but it does not represent the
optimal therapy since, having to implant large areas of loss of substance, the skin
removal would be so large to considerably increase the disepithelialized area and, in
case of failure of the graft, it would surely cause a worsening in the conditions of the
patient. So far we treated 12 patients, all suffering from sacral pressure sores, with a
variable surface between 25 and 45 sq cm.
In all patients we took very limited amounts of thin skin-grafts, in order not to
provoke an increase of the damaged area.
A surgical courettage of the ulcers was made, to eliminate hypertrophic granulations;
in some cases the toilette was performed using a dermal scraper.
In the last 4 patients, we replaced the homografts with CONDRESS, heterologous
collagen. A compressive dressing has been made and removed at 48 hours, after
control of the successful implant.
The patients were positioned to avoid decubitus on the grafter area during 10 days
after the intervention and, possibly, even more.
The microautoskingrafts positioned on the damaged areas were successful in about
80% of the treated patients.
The complete recovery took place between 42 and 57 days from intervention.
After about 10 days from grafting the implants started to spread, with a tendency to
come together and reaching a size 4-5 times higher than the original.
It has to be highlighted that the most recent 4 cases treated with CONDRESS healed
more quickly, with a faster growth of the grafts compared to the other patients and
reducing the total recovery time.
The favourable results achieved encourage to the use of this technique.