MedPath

Nonsilicone Gel Sheet for Burn Hypertrophic Scars

Not Applicable
Recruiting
Conditions
Burn Scar
Registration Number
NCT05429411
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
36
Inclusion Criteria

Inclusion Criteria:<br><br> - Females and males, of any race<br><br> - 16 years or older who were admitted to the Montreal Burn Centre for the treatment of<br> a thermal burn injury<br><br> - Scar sites that show clinical evidence of HSc (>2.034 mm thick as measured by high<br> frequency ultrasound and hyperaemic - defined as Mexameter erythema index >300)<br><br> - Understand French or English<br><br> - Signed the informed patient consent form.<br><br>Exclusion Criteria:<br><br> - Suspected or known allergy to ultrasound gel<br><br> - Formed keloid scars<br><br> - Scar site that are mature (defined as Mexameter erythema index <300 and <2.034 mm<br> thick)<br><br> - Diagnosed with a psychiatric illness that will impair the subjects ability to<br> participate in the study or provide informed consent<br><br> - Mechanism of injury is an electrical, chemical, or cold injury<br><br> - Dermatological condition such as psoriasis, eczema, etc., in the region of the<br> evaluation site, which in the investigator's opinion, may interfere with the study<br> results.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Skin Erythema Changes;Skin Elasticity Changes;Skin Thickness Changes
Secondary Outcome Measures
NameTimeMethod
Patient reported treatment efficacy
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