Prevention of Postsurgical Scars: Comparsion of Efficacy and Convenience between Silicone Gel Sheet and Topical Silicone Gel

Abstract

To date, few studies have compared the effectiveness of topical silicone gels versus that of silicone gel sheets in preventing scars. In this prospective study, we compared the efficacy and the convenience of use of the 2 products. We enrolled 30 patients who had undergone a surgical procedure 2 weeks to 3 months before joining the study. These participants were randomly assigned to 2 treatment arms: one for treatment with a silicone gel sheet, and the other for treatment with a topical silicone gel. Vancouver Scar Scale (VSS) scores were obtained for all patients; in addition, participants completed scoring patient questionnaires 1 and 3 months after treatment onset. Our results reveal not only that no significant difference in efficacy exists between the 2 products but also that topical silicone gels are more convenient to use. While previous studies have advocated for silicone gel sheets as first-line therapies in postoperative scar management, we maintain that similar effects can be expected with topical silicone gel. The authors recommend that, when clinicians have a choice of silicone-based products for scar prevention, they should focus on each patient's scar location, lifestyle, and willingness to undergo scar prevention treatment.

Graphical Abstract

Full text

© 2014 The Korean Academy of Medical Sciences.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0)
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pISSN 1011-8934
eISSN 1598-6357
Prevention of Postsurgical Scars: Comparsion of Ecacy and
Convenience between Silicone Gel Sheet and Topical Silicone
Gel
To date, few studies have compared the effectiveness of topical silicone gels versus that of
silicone gel sheets in preventing scars. In this prospective study, we compared the efficacy
and the convenience of use of the 2 products. We enrolled 30 patients who had undergone
a surgical procedure 2 weeks to 3 months before joining the study. These participants were
randomly assigned to 2 treatment arms: one for treatment with a silicone gel sheet, and
the other for treatment with a topical silicone gel. Vancouver Scar Scale (VSS) scores were
obtained for all patients; in addition, participants completed scoring patient questionnaires
1 and 3 months after treatment onset. Our results reveal not only that no significant
difference in efficacy exists between the 2 products but also that topical silicone gels are
more convenient to use. While previous studies have advocated for silicone gel sheets as
first-line therapies in postoperative scar management, we maintain that similar effects can
be expected with topical silicone gel. The authors recommend that, when clinicians have a
choice of silicone-based products for scar prevention, they should focus on each patient’s
scar location, lifestyle, and willingness to undergo scar prevention treatment.
Keywords: Cicatrix; Postoperative Period; Wounds and Injuries; Prevention and Control
Sue-Min Kim, Jung-Sik Choi,
Jung-Ho Lee, Young-Jin Kim,
and Young-Joon Jun
Department of Plastic & Reconstructive Surgery,
Bucheon St. Mary’s Hospital, The Catholic University
of Korea, Bucheon, Korea
Received: 6 June 2014
Accepted: 28 July 2014
Address for Correspondence:
Young-Joon Jun, MD
Department of Plastic and Reconstructive Surgery, The Catholic
University of Korea, Bucheon St. Mary’s Hospital, 327 Sosa-ro
327-beon-gil, Wonmi-gu, Bucheon 420-717, Korea
Tel: +82.32-340-7062, Fax: +82.32-340-7062
E-mail: joony@catholic.ac.kr
http://dx.doi.org/10.3346/ jkms.2014.29.S3.S249 • J Korean Med Sci 2014; 29: S249-253
INTRODUCTION
Silicone-based products are widely used to limit pathologic
scars. Using these products is cost- and time-eective, as well
as more convenient and comfortable for patients. To date, a
substantial number of studies have assessed the efficacy of
these products in preventing scars, but have reached no deni-
tive conclusions. However, in certain randomized, controlled
studies, these products were signicantly eective in reducing
postoperative incision wound scarring (1-4). Currently, several
types of silicone-based products are available for clinical use
(5). Of these, silicone gel sheets and topical silicone gels are the
most popular forms (5-7). However, both have known limita-
tions and can be inconvenient for patients to use, thus posing a
risk of to misuse or treatment interruption. Specically, silicone
gel sheets are disadvantageous because they cannot be applied
to mobile or visible areas of the body, and require additional
taping or bandaging (3, 4). Moreover, the sheets cannot achieve
and maintain adequate contact with scars when applied to the
skin with an irregular contour (3). On the other hand, topical
silicone gels take time to completely dry (4). Furthermore, pa-
tients have to take extra sunsceen precautions to prevent hy-
perpigmentation, and must also apply topical silicone gels to
scars multiple times per day (4, 8). Few studies have compared
the effectiveness of topical silicone gels to that of silicone gel
sheets in surgical scar prevention. Consequently, we conducted
this prospective study to examine both the ecacy and the con-
venience of each product.
MATERIALS AND METHODS
Patients and study design
is study enrolled 30 patients between January and November
2012. Participant inclusion criteria were as follows:
1) History of surgery 2 weeks to 3 months before enrollment
2) Scarring of a surface area < 10 × 10 cm2
3) Age 18 yr or older
Exclusion criteria were as follows:
1) Any infection
2) Any wound producing a signicant amount of discharge,
e.g., still requiring a dressing 2 weeks after surgery or lack-
ing visible signs of normal epithelialization
3) Any systemic disease (e.g., diabetes mellitus, hematologic
disorder, or dermatologic disorder)
4) Use of anticancer, psychiatric, or steroid medication
5) Psychiatric disorder
6) Deemed unable to complete the study according to the
judgment of the authors.
ORIGINAL ARTICLE

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Evaluation criteria and outcome measures
All patients were randomly assigned to and equally distributed
between 2 treatment arms (treatment with either a silicone gel
sheet [ScarclinicTM-in, Hans Biomed, Seoul, Korea] or a topi-
cal silicone gel [Kelo-CoteTM, SejongMedix, Seoul, Korea]). e
arms were categorized as Group I (n = 15) and II (n = 15), re-
spectively. First, patients’ scars were photographed and evalu-
ated using the Vancouver Scar Scale (VSS), for which their vas-
cularity, pigmentation, pliability, height, pain, and itchiness were
measured as outcomes (Table 1) (6, 9). The aforementioned
evaluation was performed by 2 independent observers. We also
recorded patients’ questionnaire responses about any scar-re-
lated pain, pruritus, color change, hardness, thickness, overall
size, irregularity, and inconvenience of use they experienced,
and scored them using a 10-point scale (Table 2). en, we eval-
uated the VSS scores and patient questionnaire scores at 1 and
3 months and compared them with the baseline measurements.
Table 1. Vancouver Scar Scale
Feature Score
Vascularity Normal
Pink
Red
Purple
0
1
2
3
P igmenta-
tion
Normal
Hypo-pigmentation
Mixed-pigmentation
Hyper-pigmentation
0
1
2
3
P liability
(Elasticity)
Normal
Supple (flexible with minimal resistance)
Yielding (giving way to pressure)
Firm (inflexible, not easily moved, resistant to manual pressure)
Banding (rope-like tissue that blanches with extension of the scar)
Contracture (permanent shortening of scar, producing deformity
or distortion)
0
1
2
3
4
5
Height Flat
< 2 mm
2-5 mm
> 5 mm
0
1
2
3
Pain None
Occasional
Requires medication
0
1
2
Itchiness None
Occasional
Requires medication
0
1
2
Table 2. Patient questionnaire
Yes 1 2 3 4 5 6 7 8 9 10 No
Improved Aggravated
1 Do you have any pain on your scar?
2 Is there any pururitus on your scar?
3 Do you see any change of color on your scar?
4 Do you feel your scar getting hardened?
5 Does your scar get thicker or increase in size?
6 Does your scar change into irregular shape?
7 Was it uncomfortable to use?
Fig. 1. (A) Before and after views of silicone gel sheet use in scar management. The scar has improved in its vascularity, irregularity, and height after 3 months of treatment. (B)
Before and after views of topical silicone gel use in scar management. The scar has improved in its pigmentation, irregularity, and height after 3 months of treatment.
A
B

Kim S-M, et al. • Silicone-based Products for Prevention of the Postoperative Scars
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Statistical analysis
Statistical analysis was performed using SPSS version 16.0 for
Windows (SPSS, Inc., Chicago, IL, USA). All data were express-
ed as mean ± standard deviation (SD). We used the Mann-Whit-
ney test to compare outcome measures between the two groups.
A P value of < 0.05 was considered statistically signicant.
Ethics statement
is study was approved by the institutional review board (IRB)
of our medical institution (IRB approval number: HC11DSSI0091).
All patients were informed of the study details (e.g., objectives,
methods, predicted outcomes, adverse eects, and study devi-
ces), and submitted a signed informed consent document.
RESULTS
Baseline and clinical characteristics of the patients
We enrolled 30 patients (n = 30) in our study. Of these, 5 dropped
out for personal reasons; therefore, 11 patients in Group I and
14 in Group II completed the study. ese participants includ-
ed 9 male and 16 female patients with a mean age of 37.52 yr
(total range, 21-75 yr). When recording scar location, we observ-
ed 17, 7, and 1 patients with scars in the head and neck region,
in the extremities, and in the trunk, respectively. All patients
demonstrated tolerability for the treatment; none experienced
specic clinical problems. By the conclusion of the study peri-
od, all patients’ scars had improved in terms of pigmentation,
height, irregularity, and overall size (Fig. 1).
Changes from baseline in VSS scores at 1 and 3 months
after treatment onset
At 1 month after treatment onset, we observed a degree of pain
score change of -0.455 points in Group I and 0.143 points in
Group II. This difference reached statistical significance (P=
0.033). However, with the exception of the pain score, as shown
in Fig. 2, no signicant dierences were observed between ei-
ther group in either their VSS scores by outcome measure or
their total scores at 1 and 3 months from baseline.
Fig. 2. (A) Changes from the baseline in VSS scores at 1 month after treatment onset. (B) Changes from the baseline in VSS scores at 3 months after treatment onset. VSS,
vancouver scar scale.
1
0.5
0
-0.5
-1
-1.5
-2
-2.5
-3
-3.5
-4
-4.5
-5
Vascularity
Pigmentation
Pliability
Height
Pain
Itchiness
Total
Silicone gel sheet
Topical silicone gel 1
0.5
0
-0.5
-1
-1.5
-2
-2.5
-3
-3.5
-4
-4.5
-5
Vascularity
Pigmentation
Pliability
Height
Pain
Itchiness
Total
Silicone gel sheet
Topical silicone gel
A B
Fig. 3. (A) Changes from the baseline in patient questionnaire response scores at 1 month after treatment onset. (B) Changes from the baseline in patient questionnaire response
scores at 3 months after treatment onset.
A B
1
0.5
0
-0.5
-1
-1.5
-2
-2.5
-3
-3.5
-4
-4.5
-5
Silicone gel sheet
Topical silicone gel
1
0.5
0
-0.5
-1
-1.5
-2
-2.5
-3
-3.5
-4
-4.5
-5
Silicone gel sheet
Topical silicone gel
Pain
Pruritus
Color change
Hardness
Thickness and size
Irregularity
Pain
Pruritus
Color change
Hardness
Thickness and size
Irregularity

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Changes from baseline in patient questionnaire response
scoring at 1 and 3 months after treatment onset
At 3 months after treatment onset, questionnaire response scores
for inconvenience of use were 3.818 points in Group I and 1.571
points in Group II. is dierence also reached statistical sig-
nificance (P= 0.015). However, no significant differences be-
tween the groups were seen in any other outcome measures at
1 or 3 months from baseline (Fig. 3).
DISCUSSION
Several treatment and prevention methods for surgical scarring
are available today. ese include intralesional corticosteroids;
5-fluorouracil; bleomycin; cryotherapy; silicone gel; pressure
therapy; pulsed dye laser treatment; radiation; and surgical cor-
rection (10-12). Emerging scar-reducing therapies include the
TGF-β superfamily; COX-2 inhibitors and nonsteroidal anti-in-
ammatory drugs; collagen synthesis inhibitors; angiotensin-
converting enzyme inhibitors; minocycline; and gene therapy
(11). Among these methods, silicone has typically been consid-
ered the standard noninvasive approach (13).
Since the early 1980s, silicone has been described as having
potential effectiveness in treating pathological scars (14). To-
day, it is considered a conventional scar treatment approach
(15-17). Indeed, a number of studies have assessed silicone’s
ecacy in preventing scar formation during the postoperative
period (1-4); it is frequently used after surgery because it is both
non-invasive and causes few adverse eects (8, 16). However, a
matter of controversy is whether silicone is truly eective in scar
prevention (1, 18).
Various mechanisms have been proposed as possible modes
of action for silicone materials. ese hypotheses include incre-
ased temperature or oxygen tension, direct action of silicone
oil, wound hydration, polarization of scar tissue caused by neg-
ative static charge and modulation of growth factors (7, 9, 10,
13). Silicone has been produced in several forms, including sili-
cone cream compounds; silicone oil or gel, with additives such
as Vitamin E; in combination with other dressing materials, and
as custom-made silicone applications (18). Among these for-
mats, silicone gel sheets are the most widely used; however, pa-
tients’ compliance with silicone gel sheet use is not always sat-
isfactory. e silicone gel sheets are inconvenient for patients
to apply to large mobile areas, such as the area near the joints,
and are generally not appropriate to use on visible areas like the
face (3). Taping or bandaging is required to secure the silicone
gel sheet to the scar, which may cause irritation in patients with
pliable skin, particularly the elderly and the young (4). More-
over, silicone gel sheets may also cause excessive sweating in
hot and humid climates (4). ey must be washed carefully to
prevent infections and other complications (3). All of the above
factors often lead to interruption of gel sheet treatment. Topical
silicone gels, by contrast, are available in a tube, and can be ap-
plied in a thin layer on the skin. ey form a exible, gas-per-
meable and invisible lm on the scar (4); they may also be spread
on the scar and will dry up within a period of several minutes,
allowing patients to then wear clothes or apply makeup. In ad-
dition, topical silicone gels are advantageous in that they require
no xation materials. At the same time, these gels do pose dis-
advantages: they must be used in combination with sunscreen
to prevent hyperpigmentation and must also be applied multi-
ple times each day (8). Patients must also be sure that gel applied
to parts of the body covered by clothing have dried completely
before they get dressed; failure to do so may result in friction
that removes the silicone lm too early (4). Finally, these gels
cannot be applied to the periocular or perioral area, particularly
in younger patients.
Karagoz et al. (8) compared the ecacy of a topical silicone
gel, a silicone gel sheet and a topical onion extract in treating
postburn hypertrophic scars, and reported that the two silicone
based-products were more eective than the onion extract. e
authors also found no signicant dierence in the eectiveness
of the two silicone-based products in treating hypertrophic scars.
However, they did conclude that silicone gel sheets are the pref-
erable method of treatment. is is not only because the degree
of treatment response was relatively higher in the silicone gel
sheet group but also because 1 patient in their study showed no
response to the topical silicone gel. In addition, Mustoe et al. (15)
also deemed silicone gel sheets worthy of consideration as a rst-
line of therapy for scar prevention.
It was the objective of our study to compare both ecacy and
convenience of use in silicone gel sheets and topical silicone
gels as surgical scar preventives. Between our two groups, we
found no statistically signicant dierences in either VSS or ques-
tionnaire response scores at 1 or 3 months after treatment on-
set. e only signicant dierence observed was the degree of
change in VSS pain scores at 1 month. While we assume the sil-
icone gel sheet oers a greater degree of stability and protection
in the early stages of scar formation, we could nd no statistical-
ly signicant dierence in the degree of VSS pain score changes
at 3 months after treatment onset. Meanwhile, the patient ques-
tionnaire inconvenience of use score was higher in our silicone
gel sheet group at 3 months after treatment onset. is means
that convenience of use proved greater in the topical silicone
gel group. Our results prove that topical silicone gel is as eec-
tive as silicone gel sheet for preventing surgical scars and that it
is also easier to use.
Our study did face several limitations. Although scar matura-
tion can continue for up to a year after surgery, we followed scar
progression for only 3 months. Previous studies that evaluated
the efficacy of silicone gel in scar management also typically
followed scar progression for a 2- to 4-month period (4, 19-21).
We believe this is because many clinicians regard that the early

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stage of scar remodeling is the time of greatest change. An ad-
ditional limitation was that our study population was small and
consisted solely of Korean patients. Finally, when using the sili-
cone gel sheet, patients who also used tape or bandaging to se-
cure the sheet in arbitrary fashion may have inuenced the pig-
mentation of their scars.
In conclusion, numerous silicone-based products are used
in modern management of postoperative scars. Clinicians should
select products for each patient while considering both their ef-
cacy and convenience of use. Scar management is an ongoing
process over a course of at least 3 to 6 months. It is therefore es-
sential to ensure patient compliance throughout the treatment
process. Consequently, clinicians must also carefully weigh the
characteristics, lifestyle, and compliance likelihood of each pa-
tient, as well as the location of their scars, in choosing the appro-
priate management modality. In our study, we have demon-
strated that there is no signicant dierence in the degree of ef-
cacy between either silicone-based product types; at the same
time, our results indicate that topical silicone gels are more con-
venient for patients to use than silicone gel sheets. While previ-
ous studies have advocated for silicone gel sheets as rst-line
therapies in postoperative scar management, we maintain that
similar eects can be expected with topical silicone gel. Further
long-term, large-scale, prospective controlled studies are likely
warranted to conrm our ndings.
DISCLOSURE
ere are no conict of interest statements.
ORCID
Sue Min Kim http://orcid.org/0000-0002-0894-5207
Jung-Sik Choi http://orcid.org/0000-0002-9603-8235
Jung Ho Lee http://orcid.org/0000-0002-3800-5494
Young Jin Kim http://orcid.org/0000-0002-9046-9907
Young Joon Jun http://orcid.org/0000-0002-2678-9092
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