Non-silicone Gel Sheet for Burn Scars

Recruiting at 1 trial location

Overseen By Bernadette Nedelec

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Keloid scars, Psychiatric illness, Dermatological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-silicone gel sheet to determine if it improves burn scars, known as hypertrophic scars, by reducing thickness, redness, pain, and itchiness. Researchers will compare scars treated with the gel sheet to untreated scars on the same person to identify differences. Individuals with burn scars from a thermal injury receiving treatment at CHUM or Villa Medica might be suitable candidates. Incorrect use of the gel may cause minor skin redness, but this resolves quickly once use is stopped.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance scar treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this non-silicone gel sheet is safe for treating burn scars?

Research has shown that non-silicone gel sheets are generally safe for treating burn scars. Earlier studies identified minor redness as the main side effect, occurring in about 10-25% of cases when the gel sheets were not used properly. This redness typically resolves quickly after discontinuing use.

The gel sheets aid scar healing by maintaining skin moisture and stability. As a non-invasive option, they do not involve surgery or needles, enhancing their safety profile. Although some studies have shown positive results, the overall evidence remains weak due to limitations in past trials.

In summary, non-silicone gel sheets appear well-tolerated with only minor side effects, making them a relatively safe option for those considering participation in a clinical trial for burn scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for burn scars, which typically involves silicone gel sheets, the non-silicone gel sheet offers a unique alternative. Researchers are excited about this treatment because it provides a new approach for individuals who may have sensitivities or allergies to silicone-based products. This gel sheet might offer similar scar improvement benefits without the potential drawbacks associated with silicone, making it a promising option for a broader range of patients.

What evidence suggests that this non-silicone gel sheet is effective for burn scars?

Research has shown that silicone gel sheets are the best option for treating hypertrophic scars, which are thick, raised scars that can form after a burn. However, this trial is studying a different type of gel sheet that does not contain silicone. Participants will be in one of two groups: one receiving the non-silicone gel sheet treatment and the other receiving standard care with no intervention. Although strong data on these non-silicone gel sheets is limited, some early studies have shown promising results. These gel sheets are designed to be placed over scars to help reduce their thickness, redness, and itchiness. The current study aims to use better tools to more accurately measure the effectiveness of these sheets. Although the evidence is still developing, the goal is to find a non-silicone option for scar treatment. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for burn survivors aged 16 or older with hypertrophic scars from thermal burns, who can understand French or English and have signed the consent form. It's not for those with certain psychiatric illnesses, mature scars, non-thermal burn injuries, allergies to ultrasound gel, keloid scars formation tendencies, or skin conditions like psoriasis near the scar.

Inclusion Criteria

I understand French or English.

I am of any gender and race.

I am 16 or older and was treated for a burn injury at the Montreal Burn Centre.

Exclusion Criteria

You have keloid scars.

Diagnosed with a psychiatric illness that will impair the subjects ability to participate in the study or provide informed consent

My injury was caused by electricity, chemicals, or cold.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply a non-silicone gel sheet to hypertrophic scars with a gradual increase in wear time until reaching over 21 hours per day

3 months

Baseline, 1 month, 2 months, 3 months

Follow-up

Participants are monitored for changes in skin elasticity, thickness, and erythema after treatment

1 month

1 month post intervention

What Are the Treatments Tested in This Trial?

Interventions

• Non-silicone Gel Sheet

Trial Overview The study tests a non-silicone based gel sheet on one part of a patient's scar compared to an untreated part. It aims to measure changes in scar vascularity, thickness, pain and itchiness over time using precise electronic instruments in a controlled environment at Villa Medica Rehabilitation Hospital.

How Is the Trial Designed?

Group I: Gel treated scar Experimental Treatment 1 Intervention

Gel treated scar

Group II: Control scar Active Control 1 Intervention

No intervention, standard of care

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Topical silicone gel sheeting has been shown to effectively improve hypertrophic and keloid scars, resulting in moderate reductions in scar thickness and color.

The treatment is easy to use and painless, making it a practical option for managing challenging scars from surgical procedures or trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical silicone gel sheeting in the treatment of hypertrophic scars and keloids. A dermatologic experience. Gold, MH.[2019]

In a clinical trial involving 23 patients and 46 burn scars, topical silicone gel was found to significantly improve the surface roughness of scars after 3 months of treatment, indicating its effectiveness in scar maturation.

Patients using the silicone gel also reported significantly less itching at 3 and 6 months, suggesting that the gel not only improves scar appearance but also enhances comfort during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical silicone gel versus placebo in promoting the maturation of burn scars: a randomized controlled trial. van der Wal, MBA., van Zuijlen, PP., van de Ven, P., et al.[2021]

In a study involving 16 adult burn patients with 18 hypertrophic scars, silicone gel sheets did not significantly change blood flow in the scars or surrounding normal skin, suggesting that their mechanism of action may not be related to altering blood perfusion.

However, the application of silicone gel sheets did significantly increase the surface temperature of the hypertrophic scars, indicating that temperature changes might play a role in how these treatments work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of silicone gel sheets on perfusion of hypertrophic burn scars. Musgrave, MA., Umraw, N., Fish, JS., et al.[2019]

In a study of 25 Saudi patients with hypertrophic scars, treatment with Cica-care silicone gel sheets showed common issues such as persistent itching (80%) and skin rash (28%), but most problems could be managed with better care and hygiene practices.

Despite some patients experiencing poor responses to treatment (24%), the silicone gel sheets are generally effective, with only one patient permanently discontinuing due to lack of improvement, indicating that while side effects are common, the treatment can still be beneficial for many.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problems associated with the use of silicone gel sheeting for hypertrophic scars in the hot climate of Saudi Arabia. Nikkonen, MM., Pitkanen, JM., Al-Qattan, MM.[2019]

This systematic review evaluated the effectiveness of nonsilicone and silicone gels and gel sheets in treating hypertrophic scars and keloids resulting from burn injuries, aiming to establish evidence-based practice guidelines.

The review provides specific recommendations for healthcare providers on using these gel treatments to improve scar management for burn survivors, based on a critical appraisal of the available clinical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice guidelines for the application of nonsilicone or silicone gels and gel sheets after burn injury. Nedelec, B., Carter, A., Forbes, L., et al.[2022]

In a study involving 4 out of 7 enrolled patients, the application of silicone gel sheets on fresh surgical scars significantly reduced the levels of growth factors TGF-β1 and PDGF in both the epidermis and dermis, suggesting a mechanism for scar prevention.

The treatment also resulted in a significant increase in the expression of bFGF in the dermis, indicating that silicone gel sheets may alter growth factor levels, contributing to their effectiveness in managing hypertrophic scars and keloids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of Transforming Growth Factor β1, Platelet-Derived Growth Factor, and Basic Fibroblast Growth Factor by Silicone Gel Sheeting in Early-Stage Scarring. Choi, J., Lee, EH., Park, SW., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05429411

Nonsilicone Gel Sheet for Burn Hypertrophic Scars | ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7647509/

Efficacy of Silicone Gel versus Silicone Gel Sheet in ... This study compared 2 different forms of silicone combined with pressure garment (PG) to determine the efficacy in hypertrophic scar prevention in hand burns.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1748681514001739

Review Updated Scar Management Practical Guidelines Silicone sheets and gels are recommended as the 'gold standard', non-invasive therapies for both the prevention and the treatment of hypertrophic scars and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7539946/

Evidence‐based therapy in hypertrophic scars: An update ... Silicone gel treatment and intralesional injection of immunomodulatory drugs have recently emerged as the most promising treatment regimens, with high quality, ...

5. jkms.org jkms.org/DOIx.php?id=10.3346/jkms.2014.29.S3.S249

Prevention of Postsurgical Scars: Comparsion of Efficacy ... Our results prove that topical silicone gel is as effective as silicone gel sheet for preventing surgical scars and that it is also easier to ...

6. uptodate.com uptodate.com/contents/keloids-and-hypertrophic-scars

Keloids and hypertrophic scars - UpToDate Gel sheeting — The beneficial effects of silicone and nonsilicone sheets may reflect their ability to stabilize and moisturize the scar, thus ...