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General product and regulatory information only, not medical advice. Decisions about treating an individual scar belong to a clinician.
Short answer: what is a silicone scar sheet?
A silicone scar sheet (silicone gel sheeting) is a soft silicone sheet used in the management of closed hyperproliferative scars, meaning hypertrophic and keloid scars. In the United States it is a Class I device under 21 CFR 878.4025, exempt from 510(k) premarket notification. A 2021 Cochrane review found low or very low certainty evidence for every outcome it assessed.
Definition and scope
The FDA regulation titled “Silicone sheeting” states that the device “is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.” Two words in that sentence set the scope for anyone reading a product label: management, not removal, and closed, meaning scars where the skin has already healed over.
The Cochrane review describes silicone gel sheeting as made from medical-grade silicone reinforced with a silicone membrane backing, and as one of the most commonly used treatments for hypertrophic scars. The FDA product code for the category is MDA, listed in the agency’s Total Product Life Cycle database as “Elastomer, silicone, for scar management”, regulation number 878.4025, Class 1.
How it is thought to work
The mechanism is not settled. The authors of the Cochrane protocol write that “the potential mechanism of action of silicone therapy has not been completely determined.” The protocol says the mechanism is suggested to involve occlusion and hydration of the outer layer of the epidermis. It also notes that a slight rise in skin surface temperature could be involved, which it presents as a possibility, not a settled finding.
Wear and care details for any particular product are set by that manufacturer’s instructions for use.
Types and related concepts
| Term | What the sources say |
|---|---|
| Silicone sheeting (regulatory name) | Defined in 21 CFR 878.4025 for closed hypertrophic and keloid scars; Class I; exempt from 510(k). |
| Silicone gel sheeting (SGS) | The term used in the Cochrane review: medical-grade silicone with a silicone membrane backing. |
| Hypertrophic scar | Per the Cochrane review: a visible, elevated scar that does not spread into surrounding tissues. |
| Silicone creams or custom-made silicone products | Not the subject of the Cochrane review, which assessed silicone gel sheeting. |
What the evidence shows
The 2021 Cochrane review by Jiang and colleagues included 13 randomised controlled trials of 10 to 60 participants each. The largest comparison, silicone gel sheeting against no treatment, pooled seven studies and 177 participants.
- Against no treatment, the difference in scar severity rated by health professionals was uncertain.
- Silicone gel sheeting may slightly reduce pain.
- Certainty of evidence was low or very low for every outcome, because of imprecision and risk of bias (see GRADE evidence ratings).
- No included study measured participant-rated scar severity, quality of life or cost-effectiveness.
The review concluded that there is limited rigorous randomised evidence on the clinical effectiveness of silicone gel sheeting and that more trials are needed. For how such reviews are built, see the CASRAI entry on systematic reviews.
Where it matters for labs, clinics and supply decisions
Regulatory identity and evidence grade are the two facts a procurement or clinic-supply reader can check against primary sources. The table below lists what each check rests on.
| Check | What it rests on |
|---|---|
| Label intended use matches the regulation: management of closed hypertrophic and keloid scars | 21 CFR 878.4025(a) |
| Product sits in the Class I, general-controls category | 21 CFR 878.4025(b); FDA product code MDA |
| No premarket notification (510(k)) is required for the category, subject to the limitations in 21 CFR 878.9 | 21 CFR 878.4025(b) |
| Claims of effectiveness are read against the review evidence: low or very low certainty | Cochrane review CD013357 (2021) |
| Care and sizes come from the supplier’s instructions for use, not from general descriptions | The manufacturer’s labelling for that product |
Other CASRAI pages cover neighbouring supplies in the same way, for example hydrocolloid wound care and the Class I classification of a vinyl mattress cover. Silicone is also used as an adhesive material, covered in what is silicone adhesive.
Common misunderstandings
“Silicone sheets are the gold standard”
The Cochrane review does not support that wording. It found limited rigorous evidence and low or very low certainty for every outcome, and it called for more trials.
“FDA approved”
The classification regulation describes a Class I device, subject to general controls and exempt from 510(k) premarket notification. It describes classification and exemption, not a product-by-product approval.
“It treats any scar or wound”
The regulation’s wording is limited to closed hyperproliferative scars. It does not describe use on open wounds.
“Silicone sheets and silicone creams are the same evidence”
The Cochrane review assessed silicone gel sheeting, so its findings are not evidence about creams or other silicone products.
Frequently asked questions
What is silicone scar sheet?
It is a soft silicone sheet, usually self-adhesive, that falls under the FDA category “silicone sheeting” (21 CFR 878.4025) for the management of closed hypertrophic and keloid scars. It is a Class I device exempt from 510(k) notification.
How is it thought to work?
The leading proposal is occlusion and hydration of the outer skin layer. The Cochrane protocol states that the mechanism has not been completely determined.
How strong is the evidence?
The 2021 Cochrane review found low or very low certainty evidence for all outcomes across 13 small randomised trials, with a possible slight reduction in pain compared with no treatment.
Sources
- 21 CFR 878.4025, Silicone sheeting, eCFR, checked 2026-10-30.
- FDA Total Product Life Cycle, product code MDA, checked 2026-10-30.
- Jiang Q, Chen J, Tian F, Liu Z. Silicone gel sheeting for treating hypertrophic scars. Cochrane Database Syst Rev 2021;9:CD013357, PubMed 34564840, abstract checked 2026-10-30.
- Jiang Q, Chen J, Liu Z. Silicone gel sheeting for treating hypertrophic scars (protocol), Cochrane 2019, PMC6580700, checked 2026-10-30.
