Nonsilicone Gel Sheet for Burn Hypertrophic Scars

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Jun 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new type of gel sheet that does not contain silicone, which is being tested for its ability to help treat and prevent thick, raised scars that can develop after severe burns. Researchers want to find out how effective this gel sheet is compared to similar scar areas that do not receive the treatment. The trial will look at changes in the scars, such as their thickness, color, and how they feel, including any pain or itching.

To participate in this study, you must be at least 16 years old and have developed hypertrophic scars after being treated for a thermal burn injury. Participants will be recruited from the Montreal Burn Centre and must understand either French or English and provide consent to take part. While the gel sheet is generally safe, there is a small chance it could cause some temporary redness if not used as directed. If you meet the eligibility criteria, you could contribute to important research that may help improve treatments for burn scars.

Gender

ALL

Eligibility 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.