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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel treated scar | Experimental | Gel treated scar |
|
| Control scar | No Intervention | No intervention, standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported treatment efficacy | Visual analog scale (score 0-none to 10-worse) | Baseline, 1month post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Villa Medica Rehabilitation Hospital | Montreal | Canada |
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| ID | Term |
|---|---|
| D020034 | Silicone Gels |
| ID | Term |
|---|---|
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
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|
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |