Volume 33 Number 4

Clinical question

What is the best available evidence for silicone gel sheeting (SGS) for healing existing hypertrophic scars?

Summary

Silicone gel sheeting (SGS) (also referred to as silicone gel patch or silicone gel dressing) is a semi-occlusive, flexible dressing made of medical-grade, cross-linked silicone polymers that has been used widely as a first-line, non-invasive therapy for treatment of existing hypertrophic scars.^1-3
Silicone gel sheeting is described as having properties that maintain hydration, modulate fibroblast activity, and reduce transepidermal water loss (TEWL).^1-5 Level 1 evidence indicates that SGS might reduce scar pain compared with no SGS or using pressure garments alone. Level 1 evidence indicates that SGS may slightly improve scar severity of existing hypertrophic scars. The evidence is of low to very low certainty.⁶ Factors such as duration of treatment, adherence to the regimen and age of the scarring may influence outcomes.^{6, 7}

Clinical practice recommendations

All recommendations should be applied with consideration to the clinical presentation, the person, the health professional and the clinical context.

 

Silicone gel sheeting might be used to reduce pain and scar severity of existing hypertrophic scars. Clinical decisions should consider the severity of the individual’s signs and symptoms, their personal preferences, ability to adhere to the treatment regimen and the scar characteristics. (Grade B, weak recommendation)

 

Sources of evidence

This summary was conducted using methods published by the Joanna Briggs Institute.^8-10 The summary is based on a systematic literature search combining search terms related to ‘hypertrophic scar’ and ‘topical ‘silicone dressing’ and ’silicone gel sheeting’. First, a search was conducted in the Cochrane Database of Systematic Reviews for any relevant systematic reviews. One review⁶ published in 2021 was identified. Next, a search was made in Medline (Ovid), PubMed and Scopus for studies published in English that met the inclusion criteria for the identified Cochrane review (i.e., randomised controlled trials [RCTs].

 

Table 1. Levels of evidence for intervention studies reporting on silicone gel sheeting

 

Background

Hypertrophic scarring arises from abnormal wound healing characterised by excessive fibroblast proliferation and collagen deposition, leading to raised, erythematous, and often pruritic lesions confined to the original wound margin. When scarring extends beyond the initial wound margin, it is referred to as keloid (also known as cheloid) scar. Hypertrophic scars and keloid scars are common in surgical wounds and burn injuries.^1-5 Hypertrophic scars can cause significant physical discomfort, functional impairment, and psychological distress due to their appearance and symptoms such as pain and itching.^1-5

Silicone-based therapies, are used widely for non-invasive treatment for hypertrophic scars.^1,2,11 Although the precise mechanism of action is not fully understood, it is proposed that silicone occludes and hydrates the stratum corneum, reducing TEWL and modulating fibroblast activity and collagen synthesis, thereby promoting scar maturation.^{1-3, 5, 11-13}

Clinical evidence

Clinical evidence on SGS for treating hypertrophic scar comes from a Cochrane review⁶ at low risk of bias and an additional RCT at moderate risk of bias. The studies were generally small and included people with hypertrophic scars from burns or other trauma (see Table 2). With respect to clinical outcomes, the body of evidence reports on the effectiveness of SGS in reducing pain and scar severity. Across studies, adherence with treatment varied considerably, and its impact on clinical outcomes was not systematically evaluated.⁶ However, in one study adherence was correlated with better clinical outcomes.⁷

 

Table 2. Silicone gel sheeting/patch regimens reported in the research

 

Pain

A Cochrane review⁶ at low risk of bias reported low-certainty evidence from one RCT¹⁴ (n = 34 participants) that SGS reduces pain compared with not using SGS (mean difference [MD] −1.26, 95% confidence incidence [CI] −2.26 to −0.26). The review⁶ also reported low-certainty evidence from one RCT¹⁴ showing a mean reduction in pain for SGS with pressure garments versus pressure garments alone (MD −1.90, 95% CI −2.99 to −0.81) (Level 1). It is uncertain if this is a clinically important mean difference.¹⁵ The Cochrane review⁶ reported that it is uncertain if SGS reduces pain compared with self-adhesive propylene glycol and hydroxyethyl cellulose sheeting (MD −0.12, 95% CI −0.18 to −0.06; 1 study¹⁶, very low-certainty evidence).

The review⁶ also reported no difference between two different silicone products (elastic silicone sheeting versus nanostructured silicone bandaging) for treating pain (MD 0.70, 95% CI −0.28 to 1.68; 1 study¹⁷, very low-certainty evidence)⁶ (Level 1).

Scar severity (clinician-rated)

A Cochrane review⁶ at low risk of bias reported very low-certainty evidence that is uncertain regarding the effect of SGS in reducing scar severity compared with not using SGS (MD −1.83, 95% CI −3.77 to 0.12; 2 studies^{18, 19}) (Level 1).

The review⁶ reported low certainty evidence suggesting that using SGS may slightly reduce scar severity compared with using topical onion extract (MD −1.30, 95% CI −2.58 to −0.02; 1 study.²⁰). The review⁶ also reported that there is no clear difference in scar severity between SGS with massage versus a topical silicone-based gel (MD 0.40, 95% CI −0.88 to 1.68; 1 study¹⁴; very low-certainty evidence) or between SGS and a polyurethane dressing (MD 0.50, 95% CI −2.96 to 3.96; 1 study;²⁰ very low-certainty evidence) (Level 1).

Scar severity (clinimetrics)

The evidence published since the Cochrane review comes from a within-patient, evaluator-blinded RCT⁷ at moderate risk of bias. This study found no statistically significant differences in objective measures (see Table 2) of scar thickness, elasticity, erythema, or TEWL between SGS plus usual care and usual care alone. However, improved elasticity was observed in participants who adhered to SGS use for more than 16 hours per day (p < 0.05), suggesting that treatment adherence may influence outcomes.⁷

Considerations for use

• Silicone gel sheeting might be more effective when used for at least 16 hours/day.⁷
• The regimens generally involved treatment for six months.⁶ Level of adherence to the treatment over this duration may impact the effectiveness of treatment.
• In some of the regimens,^{19, 20} participants either had immature scars⁷ (defined based on thickness) or were within six months of acquiring the initial injury that resulted in hypertrophic scarring, The influence of time since injury on the effectiveness of treatment was not clear.
• Silicone gel sheeting is generally well tolerated, with a low incidence of mild adverse effects,^{6, 7} including minor local skin irritation.^{6, 20}

Funding

The development of this WHAM evidence summary is supported by a grant from Curtin University School of Nursing.

Conflicts of interest

The author declares no conflicts of interest in accordance with International Committee of Medical Journal Editors (ICMJE) standards.

About WHAM evidence summaries

WHAM evidence summaries are consistent with methodology published in Munn Z, Lockwood C, Moola S. The development and use of evidence summaries for point of care information systems: A streamlined rapid review approach, Worldviews Evid Based Nurs. 2015;12(3):131-8. Methods are provided in detail in resources published by the Joanna Briggs Institute as cited in this evidence summary and on the WHAM website. WHAM evidence summaries undergo peer-review by an international multidisciplinary Expert Reference Group. More information: https://www.whamwounds.com

WHAM evidence summaries provide a summary of the best available evidence on specific topics and make suggestions that can be used to inform clinical practice. Evidence contained within this summary should be evaluated by appropriately trained professionals with expertise in wound prevention and management, and the evidence should be considered in the context of the individual, the professional, the clinical setting and other relevant clinical information.

Copyright © 2025 Wound Healing and Management Collaborative, Curtin University.

Author(s)

Katrina Hulsdunk, RN, STN, P Grad Dip Wound, Ostomy and Continence Nurs, Curtin University, Wound Healing and Management (WHAM) Collaborative

Emily Haesler, PhD, P Grad Dip Adv Nurs (Gerontics), BN, Fellow Wounds Australia
Adjunct Professor, Curtin University, Curtin Medical Research Institute, Wound Healing and Management (WHAM) Collaborative

References

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