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STUDY

Prevention of Scar Spread on Trunk Excisions


A Rater-Blinded Randomized Controlled Trial
Kevin F. Kia, MD; Molly V. Burns, MD; Travis Vandergriff, MD; Sarah Weitzul, MD

Importance: Wounds that heal under tension lead to


wider and more conspicuous scars and result in decreased long-term patient satisfaction. We hypothesized that prolonged intradermal suture lifetime can decrease scar spread in wounds under tension.
Objective: To determine whether prolonged intradermal support would help decrease scar spread.

visual analog scale and Hollander Wound Evaluation


Scale.
Results: We found a statistically significant difference in
scar width between the 2 suture materials, with a mean difference of 2.3 (95% CI, 1.0-3.6) mm (P.001) favoring
P4HB. A clinically significant difference on the visual analog and Hollander Wound Evaluation scales was not identified. Suture reactions were more common with P4HB.

Design: Prospective, randomized, controlled, rater-

blinded, split-scar trial.


Setting: Outpatient dermatology clinic at Dallas Veter-

ans Affairs Hospital, Dallas, Texas.


Patients: Patients presenting with skin cancer on the
trunk were considered for the trial. We included 25 distinct surgical sites on a total of 22 patients.

Conclusions and Relevance: Prolonged intradermal


suture support leads to significantly decreased scar spread.
However, the use of a longer-acting absorbable suture increases the rate of suture reaction noted at 3 months. Further studies into less reactive, longer-acting biomaterials
are needed. In clinical practice, excisions in high-tension
areas that are classically known to spread over time can benefit from longer-acting intradermal sutures.

Intervention: After excision, the wounds were closed


with polyglactin 910 and poly-4 hydroxybutyrate (P4HB)
sutures in opposite halves of the same wound.

NCT00938691

Main Outcome Measures: Quantitative scar spread

JAMA Dermatol. 2013;149(6):687-691.


Published online April 17, 2013.
doi:10.1001/jamadermatol.2013.3004

at 12 months and qualitative assessment using a

Author Affiliations:
Department of Dermatology,
The University of Texas
Southwestern Medical Center
and Dallas Veterans Affairs
Hospital, Dallas (Drs Kia,
Vandergriff, and Weitzul); and
The University of Texas Health
Science Center San Antonio
(Dr Burns). Dr Burns is now at
the Department of Dermatology,
The University of Texas
Southwestern Medical Center,
Dallas.

Trial Registration: clinicaltrials.gov Identifier:

HE AESTHETIC OUTCOME OF

a scar after surgery for skin


cancer has been shown to
be the most important predictor of a patients overall
assessment of skin cancer treatment.1 A
higher level of patient dissatisfaction has
been noted with wounds on the trunk
compared with the face.1-3 Truncal scars
are known to spread with time, likely secondary to the greater tension inherent to
this body area.4 Orientating a scar along
the Langer lines is known to reduce tension and improve scar outcome, whereas
scars orientated against these lines are subject to increased widening.5
In the bilayer closure of surgical
wounds, buried intradermal sutures are
placed to approximate wound edges while
JAMA DERMATOL/ VOL 149 (NO. 6), JUNE 2013
687

relieving direct tension from the epidermis. Sutures are also placed superficially
to align epidermal edges, and these sutures are generally removed after 1 to 2
weeks. At that time, the wound has attained only 10% of its initial tensile
strength. The absorbable intradermal sutures are left in place to support the wound
as it develops a more robust collagen network. The absorbable suture most commonly used by US dermatologic surgeons is polyglactin 910.6 This suture
retains 50% of its strength at 3 weeks after placement and is effectively gone by 6
weeks. At 6 weeks, the healing wound has
attained only 45% of its original strength.
We hypothesize that this duration of intradermal support is insufficient for
wounds under high tension and may cre-

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Author Aff
Departmen
The Univer
Southweste
and Dallas
Hospital, D
Vandergriff
The Univer
Science Cen
(Dr Burns)
the Departm
The Univer
Southweste
Dallas.

23 Underwent assessment for eligibility

1 Excluded
1 Did not meet inclusion criteria

22 Randomized

22 Allocated to intervention A
22 Received allocated
intervention

22 Allocated to intervention B
22 Received allocated
intervention

2 Lost to follow-up

2 Lost to follow-up

20 Underwent analysis

20 Underwent analysis

Figure 1. Patient flowchart using CONSORT criteria. A total of 22


participants were enrolled in the study and intervention assignments were
randomized. Because 3 participants had multiple (2) wounds (sites of
intervention), a total of 25 wounds were enrolled in the study. Allocation
consisted of wound suturing with polyglactin 910 (intervention A) and
wound suturing with poly-4 hydroxybutyrate (intervention B). All wounds
received interventions A and B in a split-scar design, with each wound
divided into halves and individual halves assigned a suture material in a
random fashion. Two participants were lost to follow-up before the final
follow-up period; one died of pneumonia, and the other was homeless. The
total number of participants undergoing analysis was 20.

ate circumstances favoring scar spread. If this hypothesis is true, prolonged intradermal support would help
to decrease scar spread. To test this hypothesis, we conducted a prospective trial comparing polyglactin 910 with
the novel long-acting absorbable suture material poly-4
hydroxybutyrate (P4HB). A naturally occurring polyester produced by bacterial fermentation, P4HB is approved by the US Food and Drug Administration for softtissue ligation and approximation. The suture consists
of a translucent monofilament that is reported to have
initial tensile strength comparable to that of polydioxanone. The key characteristic of this new suture material
is its retention of tensile strength; at 24 weeks after placement, the material retains 30% of its original strength and
is not completely resorbed until 1 year.

the study. Patient enrollment took place from March 1 to June


30, 2009.
A split-repair design was created by repairing one-half of
the elliptical excision with 3-0 intradermal polyglactin 910 and
the other half with 3-0 intradermal P4HB. The side to which
the specific suture was assigned was randomized (using a random number generator [http://www.random.org]), and the
halves were designated as sides A and B. A polypropylene suture was used to align epidermal edges in each closure. Each
wound was repaired by the same dermatologist (K.F.K.). Allocation of suture side was kept in a sealed envelope by the clinic
support staff and not revealed to the surgeon until after the patient had consented to and been positioned for the procedure.
The patient was not able to physically visualize which sutures
were being used and was never informed of the randomization
allocation.
The primary outcome measure was scar width, measured in
millimeters. Width was measured using standardized highresolution photographs by a blinded reviewer (T.V.). A separate
measurement was also obtained in person (by K.F.K.). Scar width
was measured using calipers at the midpoint of each half of the
wound. Secondary outcome measures included measurement of
scar aesthetics by blinded dermatologists (T.V. and S.W.) applying the Hollander Wound Evaluation Scale (HWE) and visual analog scale (VAS). The HWE addressed the following 5 clinical variables: width greater than 2 mm, presence or absence of elevation,
color, presence or absence of hatch marks, and overall appearance. A score of 5 is the best possible score. The VAS is a 100-mm
line with the worst possible scar represented by a score of 0, located at the far left end, and the best possible scar represented by
a score of 100, located at the far right end. The HWE7 and VAS8
have been previously validated for use on photographs of scars.
The scores assigned by both reviewers were averaged. All measurements were taken at 3 and 12 months after surgery. Adverse
events, such as pruritus, pain, infection, suture reaction, dehiscence, and bleeding or hematoma, were also recorded and treated
appropriately.
A power analysis performed before enrollment predicted that,
with 25 participants (and an expected dropout rate of 20%),
the study would have greater than 80% power to detect a 1-mm
reduction in scar width. The study would have greater than 90%
power to detect a 15-mm difference on the VAS and a 1-U difference on the HWE. These values were previously determined to represent the mean numerical differences indicative
of a clinically significant difference.7,8 We used a paired t test
for all continuous variables. Unless otherwise indicated, data
are expressed as means (with 1 SD).
RESULTS

METHODS
We used a single-center, prospective, randomized, raterblinded clinical trial design to evaluate whether extended intradermal support would have a clinically significant effect on
scar outcome. Written informed consent was obtained from all
patients, and the study was approved by the institutional review board of the Dallas Veterans Affairs Hospital. We followed the protocols of the Declaration of Helsinki during the
study. All veterans presenting to the dermatology clinic at the
Dallas Veterans Affairs Hospital with biopsy-proven skin cancer located on the upper trunk necessitating local excision were
eligible for the trial. Exclusion criteria included current or
planned pregnancy; current breast-feeding; a history of ionizing radiation therapy, keloid or hypertrophic scarring, bleeding, or a collagen or an elastin disorder; current internal malignant disease; and current use of immunosuppressants.
Participants received financial compensation for completion of

During the study, we examined 25 lesions on a total of


22 participants, with all lesions located on the back
(Figure 1). Two patients were unavailable for follow-up before the 3-month postoperative examination
(1 death from pneumonia and 1 patient becoming homeless). Consequently, data from the remaining 23 lesions
were used for a per-protocol statistical analysis. The patients were all men, with a mean age of 68 years. The mean
excision diameter was 2.3 cm, and the mean final length
of closure was 7.2 cm. The 23 patients who remained in
the trial were included in all statistical analyses (Table).
The scar spread measured by rater-blinded review
of standardized photographs was found to be significantly different between the 2 halves at both assessments. At the 3-month analysis, the P4HB sutures had

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Table. Primary and Secondary Outcome Measure Results a

A
4.0

Polyglactin
910 Suture

Difference

P
Value

0.7 (0.7)
0.9 (1.5)

1.7 (2.5)
3.2 (4.3)

1.0 (1.6)
2.3 (3.0)

.008 b
.001 b

4.2 (1.1)
4.0 (1.2)

3.8 (1.3)
3.7 (1.4)

0.4 (0.9)
0.3 (0.7)

.07
.02 d

69 (16)
72 (13)

62 (17)
62 (19)

7 (14)
10 (12)

.03 d
.001 d

3.5
3.0

Polyglactin 910 Sutures

Scar spread, mm
3 mo
12 mo
HWE c
3 mo
12 mo
VAS, mm e
3 mo
12 mo

P4HB
Suture

2.5
2.0
1.5
1.0
0.5

a mean spread of 0.7 (0.7) mm and the polyglactin


910 had a mean spread of 1.7 (2.5) mm. The mean difference between these 2 scar spreads was 0.98 (1.61)
(95% CI, 0.28-1.67) mm (P = .008). At 12 months, the
mean scar spread for PH4B was 0.9 (1.5) mm and
for polyglactin 910 it was 3.2 (4.3) mm, with a mean
difference of 2.3 (3.0) (95% CI, 1.0-3.6) mm
(P .001) (Figure 2 and Figure 3).
At 3 months, the VAS and HWE were used to evaluate the scar as a secondary outcome. The VAS resulted
in a score of 69 for P4HB sutures and 62 for polyglactin
910 sutures, with a mean difference of 7 (14) (95% CI,
1-13) mm (P = .03). The HWE results yielded a score
of 4.2 for P4HB and 3.8 for polyglactin 910 sutures, resulting in a mean difference of 0.4 (0.9) (95% CI, 0.4
to 0.8) (P = .07). At 12 months, the VAS resulted in a score
of 72 for P4HB and 62 for polyglactin 910 sutures, with a
mean difference of 10 (12) (95% CI, 4-15) mm (P = .001).
The HWE results yielded a score of 4.0 for P4HB and 3.7
for polyglactin 910 sutures, resulting in a mean difference of 0.3 (0.7) (95% CI, 0.1-0.6) (P = .02). Although
statistically significant, none of these secondary outcome measures reached the previously validated definition of clinical significance.
The blinded review of the scars was performed via
photographs. Variability may exist between the photographic measurements and direct patient measurements. In this study, each half of the wound was compared directly with the other half, giving increased
internal validity and significance to any difference
noted in the photographs. In addition, an in-person
measurement was conducted by the primary investigator (K.F.K.). These measurements were analyzed separately from those of the blinded reviewers and showed
similarly statistically significant decreases in scar
spread in favor of the longer-acting suture. At 3
months, the PH4B sutures had a mean scar spread
of 0.5 (0.6) mm and the polyglactin 910 sutures had a
mean scar spread of 1.4 (2.5) mm. The mean difference between these 2 scar spreads was 0.9 (2.0) mm
(P = .054). At 12 months, the mean scar spread

0
0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

P4HB Sutures
B

Polyglactin 910 Sutures

Abbreviations: HWE, Hollander Wound Evaluation Scale; P4HB, poly-4


hydroxybutyrate; VAS, visual analog scale.
a Unless otherwise specified, data are expressed as mean (SD).
b Indicates a statistically significant difference.
c Indicates measured on a scale of 1 to 5.
d Indicates a statistically significant difference, but that difference did not
reach a predetermined clinical significant difference.
e Indicates measured on a scale of 1 to 100 mm.

8.0
7.5
7.0
6.5
6.0
5.5
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0
0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0

P4HB Sutures

Figure 2. Scar spread over time. Points represent individual patients with the
width of scar spread on the poly-4 hydroxybutyrate (P4HB) half plotted
on the x-axis and on the polyglactin 910 half plotted on the y-axis. The
diagonal reference line represents equal widths of both sides. Points above
this line represent patients whose scars were wider on the polyglactin side
compared with the P4HB side. A, Scar spread at 3 months after surgery.
B, Scar spread at 12 months after surgery.

for PH4B sutures was 0.8 (1.3) mm and for polyglactin


910 sutures it was 2.3 (2.7) mm, with a mean difference of 1.5 (2.3) mm (P = .004). We found no statistically significant difference between the mean differences noted by the primary investigator and the
blinded reviewer.
Complications were classified as minor and major, depending on whether they were symptomatic to the patient. The side sutured with P4HB included 8 complications (35% of the 23 wounds analyzed). Seven of these
complications were minor asymptomatic focal areas of erythema suggestive of local suture reaction. One reaction
defined as major was a significantly inflamed suture reaction with sterile abscess formation and drainage. Two
complications were noted on the polyglactin 910 side (9%
of 23 wounds analyzed). One minor asymptomatic visible suture reaction was noted. One additional patient receiving aspirin and warfarin sodium developed a hematoma; however, his secondary dehiscence was completely
isolated to the side of the wound with polyglactin 910
sutures.

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Figure 3. Two representative scars at 1 year after surgery demonstrating a


typical difference in scar spread. Thinner scars are seen on the wound halves
sutured with poly-4 hydroxybutyrate (side A) compared with polyglactin 910
(side B).

Figure 4. Example of suture reaction, an erythematous macule visible within


the scar line, at 3 months within the poly-4 hydroxybutyrate (side B) half of a
wound.

COMMENT

In the choice of suture for high-tension wounds, a surgeon must consider not only the initial tensile strength
necessary to bring the wound together but also the duration of action to keep the wound supported over time.
The most commonly used suture in dermatologic surgery, polyglactin 910, provides excellent initial tensile
strength but does not retain sufficient integrity to prevent long-term scar spread in high-tension wounds. Our
study demonstrates that prolonged intradermal support
is necessary to decrease scar spread.
Many studies have attempted to examine the relationship between scar spread and tension in a wound. Authors have attempted to prove this relationship by comparing single- vs double-layer closure. In a randomized
controlled trial,9 a comparison between single- and doublelayer closure in facial lacerations showed no significant
difference in scar outcome. A similar study10 evaluated
17 postlaminectomy wounds and found no significant difference in scar width after 2 to 3 months regardless of
intradermal sutures. A study in Japan comparing 20 inguinal wounds repaired with polydioxanone and nylon
sutures found no significant difference in scar width.11
Chantarasak et al12 found little difference in scar quality
between polyglycolic acid and polydioxanone sutures in
wounds under minimal tension. The common variable
among these studies is that their closure was conducted

on lacerations and incisional wounds, both of which exist under minimal tension. This scenario is different than
most cutaneous oncologic surgery in which adjacent skin
is being stretched to cover a defect.
Several studies support the idea that wounds under
tension heal better with more intradermal support. A study
with methods similar to those of the present study compared scar quality after closing wounds under tension with
polyglycolic acid or polydioxanone.13 Polyglycolic acid,
having a much shorter duration of action, produced significantly wider scars. Another study by Wray14 found
that scar width and appearance correlated with the amount
of tension required to close skin incisions after breast reconstruction.
Our study has several limitations that merit discussion. First, this study was performed in a uniformly white
population, and therefore the results may not generalize to other skin types. In addition, the follow-up
reported herein was restricted to 1 year after surgery. Additional follow-up may be necessary to determine longterm scar appearance.
The visible suture reactions were significantly more
common on the P4HB side than on the polyglactin 910
side. Most of these reactions were asymptomatic to the
patient (ie, erythematous macule visible within scar line
[Figure 4]). However, a similar reaction on a more visible area (the face or extremities) may have been more
distressing to the patient. In addition, 1 patient had a very
significant inflammatory response on the P4HB side leading to a significantly poorer outcome, with a VAS of less
than 10 of 100. This result demonstrates that, even if an
inflammatory reaction is infrequent, its consequences can
be clinically significant.
Overall, this study demonstrated significantly decreased scar spread favoring the longer-acting absorbable P4HB sutures. However, the use of a longer-acting
absorbable suture increased the rate of suture reaction
noted at 3 months. This study serves as proof that prolonged intradermal support will reduce scar spread in
high-tension areas. Further studies into less reactive, longer-acting biomaterials are needed.
Accepted for Publication: December 6, 2012.
Published Online: April 17, 2013. doi:10.1001
/jamadermatol.2013.3004
Correspondence: Kevin F. Kia, MD, Department of Dermatology, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 753909069 (kevinfkia@gmail.com).
Author Contributions: Dr Kia had full access to all the
data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study
concept and design: Kia, Vandergriff, and Weitzul. Acquisition of data: Kia and Vandergriff. Analysis and interpretation of data: Kia, Burns, and Vandergriff. Drafting of the
manuscript: Kia, Burns, Vandergriff, and Weitzul. Critical revision of the manuscript for important intellectual content: Kia, Burns, Vandergriff, and Weitzul. Obtained funding: Kia. Administrative, technical, and material support:
Kia, Burns, and Vandergriff. Study supervision: Kia,
Vandergriff, and Weitzul.
Conflict of Interest Disclosures: None reported.

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Funding/Support: This study was supported by a grant


from the American Society of Dermatologic Surgery. Sutures samples (P4HB) were donated by Tepha, Inc.
Role of the Sponsors: The sponsors had no role in the design and conduct of the study; in the collection, analysis,
and interpretation of data; in the preparation of the manuscript; or in the review or approval of the manuscript.
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