Nonsilicone Gel Sheet for Burn Hypertrophic Scars

NCT05429411 | Completed

• 1 other identifier: 15.386
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Burn Scar

Outcome Measures

Primary Outcomes (3)

• 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

• Skin Elasticity Changes

  Skin elasticity measures (r0- cutometer), mm

  Baseline, 1month, 2months, 3months, 1month post intervention

• Skin Thickness Changes

  Ultrasound skin measures, mm

  Baseline, 1month, 2months, 3months, 1month post intervention

Secondary Outcomes (1)

• Patient reported treatment efficacy

  Baseline, 1month post intervention

Study Arms (2)

Gel treated scar

EXPERIMENTAL

Gel treated scar

Other: Silicone gel

Control scar

NO INTERVENTION

No intervention, standard of care

Interventions

Silicone gel OTHER

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

Gel treated scar

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males, of any race
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Villa Medica Rehabilitation Hospital

Montreal, Canada

Location

MeSH Terms

Interventions

Silicone Gels

Intervention Hierarchy (Ancestors)

Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, McGill University

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 23, 2022
• Study Start: April 22, 2016
• Primary Completion: June 20, 2025
• Study Completion: October 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)