Silicone gel for Burn Scars

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Villa Medica Rehabilitation Hospital, Montréal, Canada
Burn Scars+2 More
Silicone gel - Other
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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: 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. 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.

Eligible Conditions

  • Burn Scars

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Baseline, 1month, 2months, 3months, 1month post intervention

Baseline, 1month post intervention
Patient reported treatment efficacy
Baseline, 1month, 2months, 3months, 1month post intervention
Skin Elasticity Changes
Skin Erythema Changes
Skin Thickness Changes

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control scar
1 of 2
Gel treated scar
1 of 2
Active Control
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Silicone gel · No Placebo Group · N/A

Gel treated scar
Other
Experimental Group · 1 Intervention: Silicone gel · Intervention Types: Other
Control scarNoIntervention Group · 1 Intervention: Control scar · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1month, 2months, 3months, 1month post intervention
Closest Location: Villa Medica Rehabilitation Hospital · Montréal, Canada
2008First Recorded Clinical Trial
2 TrialsResearching Burn Scars
1 CompletedClinical Trials

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
319 Previous Clinical Trials
112,213 Total Patients Enrolled
2 Trials studying Burn Scars
84 Patients Enrolled for Burn Scars

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Scar sites that show clinical evidence of HSc (>2.
You must understand French or English.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.