Nonsilicone Gel Sheet for Burn Hypertrophic Scars

Burn Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429411
• Other study ID #: 15.386
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2016
• Est. completion date: December 20, 2026

Study information

• Verified date: July 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Bernadette Nedelec
• Email: bernadette.nedelec[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 20, 2026
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion Criteria:

• Females and males, of any race
• 16 years or older who were admitted to the Montreal Burn Centre for the treatment of a thermal burn injury
• Scar sites that show clinical evidence of HSc (>2.034 mm thick as measured by high frequency ultrasound and hyperaemic - defined as Mexameter erythema index >300)
• Understand French or English
• Signed the informed patient consent form.

Exclusion Criteria:

• Suspected or known allergy to ultrasound gel
• Formed keloid scars
• Scar site that are mature (defined as Mexameter erythema index <300 and <2.034 mm thick)
• Diagnosed with a psychiatric illness that will impair the subjects ability to participate in the study or provide informed consent
• Mechanism of injury is an electrical, chemical, or cold injury
• Dermatological condition such as psoriasis, eczema, etc., in the region of the evaluation site, which in the investigator's opinion, may interfere with the study results.

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix, Hypertrophic

Intervention

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

Locations

Country	Name	City	State
Canada	Villa Medica Rehabilitation Hospital	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Erythema Changes	Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.	Baseline, 1month, 2months, 3months, 1month post intervention
Primary	Skin Elasticity Changes	Skin elasticity measures (r0- cutometer), mm	Baseline, 1month, 2months, 3months, 1month post intervention
Primary	Skin Thickness Changes	Ultrasound skin measures, mm	Baseline, 1month, 2months, 3months, 1month post intervention
Secondary	Patient reported treatment efficacy	Visual analog scale (score 0-none to 10-worse)	Baseline, 1month post intervention