Using gel sheets to treat burn scars
Randomized, Controlled, Within-patient Study to Evaluate the Efficacy of a Nonsilicone Gel Sheet for the Treatment of Hypertrophic Scar in Adult Burn Survivors
This study is testing whether a special gel sheet can help prevent and improve scars from deep burns in people who have experienced these injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 16 Years to 100 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montréal) |
| Trial ID | NCT05429411 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a non-silicone gel sheet in preventing and treating hypertrophic scars resulting from deep dermal burn injuries. Participants will wear the gel sheets for increasing durations, starting from 4 hours and gradually progressing to over 21 hours daily. The study employs a randomized, controlled, within-patient design, comparing the treatment site with a patient-matched control site to ensure accurate assessment of outcomes. The use of validated electronic measurement tools aims to provide objective data on scar improvement.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who have been admitted for thermal burn treatment and exhibit clinical signs of hypertrophic scars.
Not a fit: Patients with mature scars, keloid scars, or those with specific dermatological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of hypertrophic scars, enhancing patient quality of life.
How similar studies have performed: Previous studies on gel sheets for scar treatment have shown mixed results, indicating a need for more rigorous evaluation like this one.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montréal
- Villa Medica Rehabilitation Hospital — Montréal, Canada (Recruiting)
Study contacts
- Study coordinator: Bernadette Nedelec
- Email: bernadette.nedelec@mcgill.ca
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.