NCT05429411

Nonsilicone Gel Sheet for Burn Hypertrophic Scars

Randomized, Controlled, Within-patient Study to Evaluate the Efficacy of a Nonsilicone Gel Sheet for the Treatment of Hypertrophic Scar in Adult Burn Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants will wear the gels for 4 hours for the first 2 days, 8 hours for the second 2 days with a gradual increase of at least 2 hours/day until they reach \>21 hours/day. Once the graduate progression has been completed the gel sheet will be applied daily by the subjects for as close to 21+ hours as possible.

Conditions

• Burn Scar

Interventions

Type	Name	Description
OTHER	Silicone gel	At the selected treatment sites the participants will wear the gels for 4 hours for the first 2 days, 8 hours for the second 2 days with a gradual increase of at least 2 hours/day until they reach \>21 hours/day. Once the graduate progression has been completed the gel sheet will be applied daily by the subjects for as close to 21+ hours as possible. The gel will be removed for exercise and treatment interventions as well as personal hygiene

Timeline

• Start date: 2016-04-22
• Primary completion: 2025-06-20
• Completion: 2025-10-31
• First posted: 2022-06-23
• Last updated: 2026-03-18

Locations

1 site across 1 country: Canada