Nonsilicone Gel Sheet for Burn Hypertrophic Scars

  • End date
    Dec 20, 2026
  • participants needed
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 15 July 2022


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.


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.

Condition Burn Scar
Treatment Silicone Gel
Clinical Study IdentifierNCT05429411
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on15 July 2022


Yes No Not Sure

Inclusion Criteria

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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