Skip to main content
OpenTrials
Completed

NCT Number: NCT05429411

Nonsilicone Gel Sheet for Burn Hypertrophic Scars

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burn Scar

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Villa Medica Rehabilitation Hospital

Montreal, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Skin Erythema Changes

    Time frame: Baseline, 1month, 2months, 3months, 1month post intervention

    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.

  2. Skin Elasticity Changes

    Time frame: Baseline, 1month, 2months, 3months, 1month post intervention

    Skin elasticity measures (r0- cutometer), mm

  3. Skin Thickness Changes

    Time frame: Baseline, 1month, 2months, 3months, 1month post intervention

    Ultrasound skin measures, mm

Secondary outcomes

  1. Patient reported treatment efficacy

    Time frame: Baseline, 1month post intervention

    Visual analog scale (score 0-none to 10-worse)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.