Non-silicone Gel Sheet for Burn Scars
Trial Summary
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 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.12345
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.12345
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.13456
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.
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for changes in skin elasticity, thickness, and erythema after treatment
Treatment Details
Interventions
- Non-silicone Gel Sheet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor