Non-silicone Gel Sheet for Burn Scars

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?

Overview: The application of gel sheets holds promise for both the prevention and treatment of hypertrophic scar after deep dermal injuries. Although some positive results have been published, a Cochrane review of the data concluded that the trials were of poor quality therefore only provided weak evidence for their benefit. One of the limitations of previous studies has been the subjectivity and potential bias of the evaluation tools that were used. The validation of electronic instrumentation for the measurement of hypertrophic scar and determination of their superior clinometric properties provides the basis from which precise, systematic, evaluations can now be performed that will allow for confident conclusions to be made. Thus, the objective of this study is to evaluate the efficacy of a non-silicone gel sheet relative to a patient-matched control site in a prospective, randomized, controlled, within-patient study. This study has been piloted and the data used to establish the number of participants that will be required for an adequately powered study. Specific Objectives: 1. To characterize the changes in vascularity, thickness, pain and itch in adult burn hypertrophic scar (HSc) following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars. 2. To characterize the changes in pliability of adult burn HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars. Recruitment: Burn survivors aged 14 years and more, who have developed HSc and are being treated at CHUM and Villa Medica Rehabilitation Hospital. Risks: There is a minimal risk that the gel used in this project might cause minor redness (10-25% if the use instructions are not followed). The rash quickly resolves once the gel sheet is removed. Study Site: This study will be carried out at Villa Medica Rehabilitation Hospital.

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.

Is the non-silicone gel sheet safe for use on burn scars?

The safety of non-silicone gel sheets specifically isn't detailed, but silicone gel sheets, which are similar, have been associated with some issues like itching, skin rash, and skin breakdown. These problems were often resolved with better hygiene and care, and only one patient stopped using them due to lack of effectiveness, not safety concerns. ^{1 2 3 4 5}

How does the Non-silicone Gel Sheet treatment for burn scars differ from other treatments?

The Non-silicone Gel Sheet treatment is unique because it offers an alternative to silicone-based treatments, which are commonly used for hypertrophic scars and keloids. This treatment may provide similar benefits without the potential limitations of silicone, such as reduced adherence and movement around joints. ^{2 3 4 5 6}

What data supports the effectiveness of the treatment Non-silicone Gel Sheet for Burn Hypertrophic Scars?

While the research specifically on non-silicone gel sheets is limited, silicone gel sheets have been shown to be effective in treating hypertrophic scars, which are thick, raised scars that can form after burns. This suggests that non-silicone gel sheets might also help in managing such scars, as they are designed for similar purposes. ^{1 2 3 4 5}

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

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 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]

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 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Practice guidelines for the application of nonsilicone or silicone gels and gel sheets after burn injury. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Problems associated with the use of silicone gel sheeting for hypertrophic scars in the hot climate of Saudi Arabia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Korea (South) 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Topical silicone gel versus placebo in promoting the maturation of burn scars: a randomized controlled trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of silicone gel sheets on perfusion of hypertrophic burn scars. [2019]