Nonsilicone Gel Sheet for Burn Hypertrophic Scars

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05429411
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact	Bernadette Nedelec
Email	bernadette.nedelec@mcgill.ca
Status	Recruiting
Phase	N/A
Start date	April 22, 2016
Completion date	December 20, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.