Hypertrophic scars and keloids are common after dermal skin injury. These are often characterized by erythema, firmness, elevation, pain and pruritus1. These scars may cause both functional impairment and lead to cosmetic concerns. Silicone gel sheeting (SGS) has been used for several decades to improve the signs and symptoms of hypertrophic scars and keloids. Proposed mechanisms for the efficacy of silicone gel sheeting have included increased hydration of the stratum corneum and dermis, changes in polarization, changes in oxygen tension, pressure effects, as well as mechanical protection, all which may lead to collagen remodeling and subsequent improvement of the appearance of the scar (reviewed by Bloeman, Mustoe1,2). As pointed out by Mustoe in his review, SGS has several potential limitations including difficulty of application on some parts of the body and the requirement of taping to secure the sheeting to the skin2. Also, patients may be reluctant to use the sheeting on unclothed areas during the day, leading to decreased compliance. Additionally, sheets must be washed to prevent infection. More recently, newer formulations of silicone that may be easier to apply and maintain than sheeting have been developed, including cream containing silicone oil and silicone gel applied from a tube. Topical silicone gels have been widely distributed throughout many parts of the world for at least 15 years. There are many published reports in the scientific literature evaluating the safety and efficacy of these silicone products for improvement the signs and symptoms of scars. Scarfade is a self drying silicone gel that has been studied for the management of the signs and symptoms of keloids and hypertrophic scars. The following is a summary of the clinical evidence generated for the safety and efficacy of silicone gels for this use.
The relevant literature was assessed using four different medical databases with several different key words as listed below. A total of 27 unique articles were found and are critically reviewed in this document.
1. Cochrane Collaboration
a. Search criteria = silicone
b. Limits = none
c. # of articles found = 13
d. # of articles excluded = 12
2. PubMed
a. Search criteria = Dermatix
b. Limits = none
c. # of articles found = 2
d. # of articles excluded = 0
3. PubMed
a. Search criteria = “silicone gel” and “scar”
b. Limits = Humans, Clinical Trial, Meta-Analysis, Practice Guideline, Randomized Controlled Trial, Review, English
c. # of articles found = 26
d. # of articles excluded = 3
4. EMBASE
a. Search criteria = Dermatix
b. Limits = none
c. # of articles found = 7
d. # of articles excluded = 5 (3 = irrelevant, 2 = included in PubMed search)
5. EMBASE
a. Search criteria = “silicone gel” AND “scar”
b. Limits = Cochrane review OR Controlled clinical trial OR Meta analysis OR Randomized controlled trial OR Systematic review AND Humans AND English
c. # of articles found = 16
d. # of articles excluded = 9 (all 9 were included in the PubMed/Cochrane search)
6. Ovid MEDLINE
a. Search criteria = “Dermatix” OR “silicone gel” AND “scar”
b. Limits = none
c. # of articles identified = 53
d. # of articles excluded = 38 (either irrelevant or included in other searches)
The results are grouped into 2 sections and ordered by the level of evidence of the study. The first section contains studies evaluating the safety and efficacy of silicone gel sheeting and the second section evaluates the safety and efficacy of Dermatix (Scarfade).
Section 1
O’ Brien and Pandit3 published a Cochrane review on silicone gel analysing 15 trials involving 615 people and found that SGS reduced the incidence of hypertrophic scarring in persons prone to scarring. SGS produced a statistically significant reduction in scar thickness and improved scar colour. The authors point out that many of the studies were highly susceptible to bias and of poor quality. This analysis only included articles published up to November 2007.
Level of evidence:I
Morganroth et al4 have reviewed the medical literature for data supporting the efficacy of over the counter (OTC) scar products used on fresh post-surgical wounds. The authors found that while published evidence does not support the use of most scar products, the silicone containing products were the only ones with evidence indicating they may improve post-surgical scar appearance. The analysis did not look at mature scars.
Level of evidence: I
Berman et al5 reviewed the clinical effects of silicone elastimer sheeting for hypertropic and keloidal scar management and found that the studies generally found these products to be safe and effective. However, the authors noted that the studies suffered from small sample size, lack of objectivity, lack of standardization of the patient population, and lack of control over patient compliance.
Level of evidence: I
Li-Tsang et al6 evaluated 45 Chinese patients with hypertrophic scars in a prospective randomized investigator-blinded controlled trial comparing a silicone gel sheeting (24 hours/day x 6 months) plus massage (15 min with lanolin) to massage alone. Scar thickness was improved at the 2 month (p=0.008) and the 6 month (p<0.001) time points. Pain, itching and pliability were also improved in the treatment group compared to the control group.
Level of evidence: II
Momeni et al7 studied the efficacy of SGS (Cica-Care) applied to hypertrophic burn scars in reducing scar interference with normal function and improving cosmesis. They performed a randomised, double-blind, placebo-controlled trial involving 38 people with hypertrophic burn scars. Each scar was divided into two segments; silicone gel sheet was applied randomly to one of the two and placebo sheeting to the other. Participants were seen again after 1 and 4 months. Their data and wound characteristics were collected using the Vancouver scar scale. After 1 month all scar scale measures were lower in treated areas, but only the vascularity scale was significantly different between the two areas. After 4 months, all scale measures except for the pain score were significantly lower in the silicone gel group than in the control group. The authors concluded that silicone gel is an effective treatment for hypertrophic burn scars.
Level of evidence: II
Wittenberg et al8 compared the efficacy of the 585-nm flashlamp-pumped pulsed-dye laser (PDL) and silicone gel sheeting (SGS) in the treatment of hypertrophic scars in lighter-and darker-skinned patients in a prospective, single-blind, randomized, internally controlled, comparison investigation in 20 patients with hypertrophic scars (19 completed the PDL treatments and 18 completed the SGS treatments). Mean scar duration was 32 months (range, 4 months to 20 years). Each scar was divided into 3 sections; each section was assigned to either PDL or SGS or control. There was an overall reduction in blood flow, volume, and pruritus over time. However, no differences were detected among treatment and control groups. There was no reduction in pain or burning (0-40 weeks), elasticity (8-40 weeks), or fibrosis (0-40 weeks, n = 5 biopsies) in the treated or control sections of the scars. The authors conclude that the improvements in scar sections treated with SGS and PDL were no different than in control sections. One criticism of the study (which the authors acknowledge) is the relatively small sample size reduced the power of the study to detect minimal differences between groups (only 74%)
Level of evidence:II
Ahn et al9 assessed efficacy of silicone gel sheeting (SGS) in 14 hypertrophic scars in 10 adults for 8 weeks in a randomized controlled unblended trial. The patients served as their own controls with mirror image or adjacent scars left untreated. Scars were evaluated objectively using a volume assessment with an impression mold. Treated scars were statistically significantly improved (p<0.05) in the treated group.
Level of evidence:III-1
Gold et al10 studied two groups of subjects: those with no history of abnormal scarring (low-risk group) and those with a history of abnormal scarring (high-risk group) to determine whether topical silicone gel sheeting can be used to prevent hypertrophic scars and keloids from forming following skin surgery. Patients undergoing skin surgery were stratified into high- and low-risk groups and following the procedure, patients within each group were randomized to receive either routine postoperative care or topical silicone gel sheeting (48 hours after surgery). Patients were followed for 6 months. In the low-risk group, there were no statistical differences between individuals using routine postoperative care or using topical silicone gel sheets. In the high-risk group, those using the SGS had statistically significantly fewer abnormal scars compared to controls (39% versus 71%). Those individuals having a scar revision procedure also showed a statistical difference if topical silicone gel sheeting was used following surgery.
Level of evidence:III-1
De Giorgi et al11 evaluated the effectiveness of a silicone gel in treating surgical wounds in 110 patients in a randomized controlled trial, carried out in a dermatology department of a university hospital. Patients applied either the silicone gel or zinc oxide cream to post-surgical scars twice a day for 60 days starting the day the sutures were removed. The total follow-up period was 8 months from the date of surgery. In the treatment group, 27% had formation of a non-physiological scar (diastasic scar in 15%, hypertrophic scar in 9% and atrophic scar in 3%). No keloid scars were recorded. In the control group, 55% had an altered scar (keloid scars in 11%, hypertrophic scar in 22%, diastasic scar in 18% and atrophic scar in 4%). The authors concluded that silicone gel is able to reduce the formation of keloid and hypertrophic scars and the signs /symptoms associated with the healing process.
Level of evidence: III-1
Berman and Flores12 compared the efficacy of a cushion of silicone filled with liquid silicone gel with silicone gel sheeting in the treatment of hypertrophic and keloid scars in 32 patients. The size, volume, symptoms (tenderness and itching), and signs (color and induration) of hypertrophic (10 patients) or keloid scars (22 patients) were measured at baseline at 16 weeks following use of either the silicone gel cushion or silicone gel sheeting, as determined by random assignment. Both the silicone gel cushion and the silicone gel sheeting treatments were effective in decreasing scar volume (53.0% and 36.3% respectively), reduction in tenderness (36.3% vs 33.3%), itching (45.5% vs 33.3%), and redness (0.1% vs 0.1%), and in the degree of softening (45.5 vs 25.0%). Both the silicone gel cushion and the silicone gel sheeting treatments were effective in the treatment of keloids and hypertrophic scars, although no statistically significant differences were found between the two treatment modalities. This was a relatively small and not well-powered study.
Level of evidence:III-1
de Oliveira et al13 compared silicone and non-silicone gels and control (untreated) in 26 patients with 41 hypertrophic or keloidal scars. Scar size, symptoms and induration were measured before and after the treatment period and while there were statistical differences between treatment and control groups, there was no difference between the silicone and non-silicone groups. Blinding in this study was only used for the intracicatrical pressure measurements. The scars studied in the de Oliveira report were at least 3 years old (as opposed to fresh). There was non-standard stratification of subjects into the three groups, and the types and causes of the scars in the different groups was not uniform nor controlled. Additionally, the study was not adequately powered to detect a difference between the two treatment groups.
Level of evidence:III-2
Sproat et al14, in a prospective randomized trial, compared intralesional Kenalog to silicone sheeting (Spenco) for hypertrophic sternal scars in 14 subjects. The primary outcome was patient preference. 11/14 favored the silicone gel group. This study is limited by small sample size, and lack of any objective parameters for evaluating the response of the scars to the treatment.
Level of evidence:III-2
Rhee et al15 evaluated the effect of silicone gel sheets to new scars after cosmetic surgery in 40 Asian patients in a prospective controlled trial. By 3 months, pigmentation, vascularity, and height of the scars were statistically significantly improved in the silicone gel group compared to the control group.
Level of evidence: III-2
Tan et al16 performed a prospective, non-randomized patient-controlled study aimed to assess the effectiveness of topical silicone gel sheet used for 12 weeks and intralesional injections of triamcinolone acetonide (40 mg/ml) in the treatment of keloids in 20 patients with multiple keloids. In each patient, three keloids of similar size were selected. One was assigned to no treatment (control) and one to each active treatment. None of the untreated control lesions showed any spontaneous reduction in size. Of the lesions treated with silicone gel sheet dressing, only 2 of 17 (12) showed a significant reduction in size (i.e. at least 50 reduction in size) at week 12. Of the lesions treated with intralesional injections of triamcinolone acetonide (40mg/ml), 16 of 17 (94) showed a significant reduction in size at week 12. Their results do not support the use of occlusive silicone gel sheet as an effective treatment of chronic keloid scars
Level of evidence: III-2
Majan17 compared the efficacy of a self-adherent soft silicone dressing (Mepiform) with ‘left-alone’ management of hypertrophic scars after cosmetic surgery in a non-blinded randomised controlled clinical investigation on 11 female patients aged 21–43 years. Treatment was initiated between two weeks and two months (mean 4.7 weeks) after surgery. All parameters in the Vancouver Scar Scale improved in both groups, Patients treated with the soft silicone dressing showed greater and more rapid improvements compared with the non-treated patients. Unfortunately, there was no statistical analysis of evaluating the significance of their findings. One subject had local skin irritation at the site of the scar.
Level of evidence:IV
Hirshowitz et al18 developed a silicone cushion with the purpose of increasing a negative static electric charge to accelerate the scar regression process. Thirty patients enrolled in the study (27 completed). Treatment with the silicone cushions yielded 63.3 percent cessation of itching and burning followed by pallor and flattening of the scar, some markedly so, over a few weeks to 6-month period. An additional 26.6 percent had their scars resolved in up to 12 months of treatment. This study is limited by a lack of a control group.
Level of evidence:IV
Eishi et al19 evaluated 6 patients with hypertrophic scars treated
With silicone gel sheeting (Cica-Care) for 24 weeks. They found that pain and pruritus decreased after 4 weeks and resolved after 12 weeks. Reduction of redness and elevation was observed after 12 weeks.
Level of evidence: IV
Brown20 published a case involving an 18-month-old child whose burn scar was treated for a period of 15 months with silicone gel sheets. The Vancouver Burn Scar Scale assessment showed improvement in the scar (score improved from 9 to 2). Unfortunately, the natural history of this scar without treatment is unknown.
Level of evidence: IV
Section 1b: Safety
Nikkonen et al21 examined twenty five consecutive Saudi patients who underwent treatment of hypertrophic scars using Cica-care silicone gel sheets. The scars were secondary to burns or traumatic friction injuries. The authors reported that problems associated with gel sheeting were common and included persistant pruritis (80%), skin breakdown (8%), skin rash (28%), skin maceration (16%), foul smell from the gel (4%), poor durability of the sheet (8%), failure of the sheet to improve hydration of dry scars (52%), poor patient compliance (12%) and poor response of the scar to treatment (24%). Most of these problems were eliminated by temporary interruption of treatment, more frequent washings of the gel sheet, better skin hygiene and occasionally by changing the brand of gel sheets. Permanent discontinuation of treatment occurred in only one patient and was because of lack of response to treatment.
Level of evidence:IV
Alexander and Ebrahim22 reported spontaneous bleeding in a keloidal scar treated with intralesional triamcinolone and silicone sheeting (Cica-care). It is impossible to discern from this report whether the bleeding was related to the silicone sheeting.
Level of evidence: IV
Section 2
Mustoe2, in 2008, reviewed the available literature on silicone therapy for scars. Results from clinical trials in that review suggest that silicone gel is equivalent in efficacy to traditional silicone gel sheeting but easier to use. Although high quality comparative clinical trials are lacking, the reported clinical studies suggest that silicone gel is at least as effective as SGS in scar management. There have been no reported safety issues.
Level of evidence: 1
Chan et al23 conducted a randomized, placebo-controlled, double-blind, prospective clinical trial comparing a silicone gel (Scarfade ) to a placebo gel in adult Asian patients with sternotomy scars after cardiac surgery. One hundred wounds in 50 patients were randomized into two arms with each patient serving as his/her own control with either the upper of the lower half of the scar receiving active or control gel twice a day. No side effect caused by the silicone gel was reported. Ninety-eight percent of patients had moderate to good compliance. The incidence of sternotomy scar was 94 percent. At the third month postoperatively, the silicone gel wounds were scored lower (better) when compared with the control wounds. The differences were statistically significant in all parameters, including pigmentation (p =0.02), vascularity (p = 0.001), pliability (p = 0.001), height (p = 0.001), pain (p = 0.001), and itchiness (p = 0.02).
Level of evidence:II
Karagoz et al24 compared the efficacy of silicone gel (Scarfade*), silicone gel sheet (Epi-DermTM), and topical onion extract including heparin and allantoin (Contractubex1) for the treatment of hypertrophic scars. Forty-five postburn scars were included in the study. Patients with scars less than 6 months from injury were assigned at random to three groups each containing 15 scars, and treatment with Scarfade, EpidermTM and Contractubex1 was continued for 6 months. Scar assessment was performed at the beginning of the treatment, and at the end of the sixth month when the treatment was completed by using the Vancouver scar scale. The difference between before and after treatment scores for each three groups was statistically significant. The difference between Scarfade group and Epi-DermTM group was not significant; however, the differences of the other groups (Scarfade-Contractubex1 , EpidermTM-Contractubex1) were significant. This study was not blinded.
Level of evidence:III-1
Signorini and Clementoni25 studied fresh surgical scars treated with silicone gel (Dermatix) in a prospective, controlled non-blinded trial in a group of 160 patients. All had undergone surgery 10 days to 3 weeks previously. The treatment group applied Dermatix twice a day for 4 months. The control group had no treatment initially but if there was clear evidence of developing hypertrophies, conventional treatments (pressure garments, intralesional steroids, or traditional silicone gel sheeting) were prescribed. The locations of the scars were controlled for. The patients treated with the self-drying silicone gel evidenced grade 1 (normal) scars in 67% of the cases at the end of the observation period, as compared with 28% of the control cases. Grade 2 (mildly hypertrophic) scars were noted in 26% in the treated group, as compared with 46% of the control group. Grades 3 (hypertrophic) and 4 (keloid) scars were noted in 7% in the treated group and 26% in the control group. These differences were statistically significant (p < 0.001).
Level of evidence:III-1
Lacarrubba et al26 examined 8 patients with hypertrophic scars in an open label trial in which subjects applied a self drying silicone gel (the authors do not state whether this is Dermatix or another self drying silicone gel product) to their scars. Three untreated scars in subjects with multiple scars served as controls. The scars were treated within 90 days of onset twice a day for up to six months. Scar size, redness and textural improvement were evaluated. The scars treated with the silicone gel had a 50-90% improvement in 5/8, had a 30-49% improvement in 2/8, and had a 10 years), and only gives overview of silicones in the rehab of burns.
Bloemen et al, 2009,
Prevention and curative management of hypertrophic scar formation Does not focus on silicone and does not review the literature critically
Fette, 2006,
Influence of silicone on abnormal scarring Does not critically appraise the literature
Gilman et al, 2003,
Silicone sheet for treatment and prevention of hypertrophic scar: a new proposal for the mechanism of efficacy Opinion on mechanism of action not clinical data
Hanasono et al, 2004,
The effect of silicone gel on basic fibroblast growth factor levels in fibroblast cell culture In vitro data on effects of silicone on fibroblasts
Paper – Author, year, title Reason for exclusion
Kloeters et al, 2007,
Hypertrophic scar model in the rabbit ear: a reproducible model for studying scar tissue behavior with new observations on silicone gel sheeting for scar reduction Rabbit ear model not clinical study
O’Shaughnessy et al, 2009,
Homeostasis of the epidermal barrier layer: a theory of how occlusion reduces hypertrophic scarring
Not a clinical study. This report deals with barrier repair, occlusion and scarring in an animal model
Reish et al, 2008,
Scars: a review of emerging and currently available therapies Includes many modalities and does not critically appraise silicone treatments
Reish et al, 2008,
Scar treatments: preclinical and clinical studies Includes many modalities and does not critically appraise silicone treatments
Tandara et al, 2008,
The role of the epidermis in the control of scarring: evidence for mechanism of action for silicone gel Rabbit model of role of epidermis in scarring
Watkins et al, 2008,
When wound healing goes awry. A review of normal and abnormal wound healing, scar pathophysiology, and therapeutics Does not critically appraise literature
Rea et al, 2008,
Use of the Internet by burns patients, their families and friends
Not related to efficacy of the topical silicone gel
Lalonde et al, 2005,
Magnetic resonance imaging of the breast: current indications
Irrelevant to topical silicone gel treatment for scars
Brown et al, 2002,
An association of silicone-gel breast implant rupture and fibromyalgia
Irrelevant to topical silicone gel treatment for scars
Rees-Lee et al,2008,
The indications for Versajet® hydrosurgical debridement in burns Dermatix is not indicated for surgical debridement
Fonseca Capdevila et al, 2007,
Prevention of scar sequels after excision of benign cutaneous lesions: Multicenter, prospective, open label, controlled study comparing a silicone gel versus silicone sheets in 131 patients with melanocytic nevi Not in English. Dermatix is not indicated for melanocytic nevi
Ralston 2003,
Do we need Harry Potter lessons? Letter referring to accessing/supply of Dermatix not efficacy