Status:
RECRUITING
Nonsilicone Gel Sheet for Burn Hypertrophic Scars
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Burn Scar
Eligibility:
All Genders
16-100 years
Phase:
NA
Brief Summary
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 Cochr...
Detailed Description
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 progr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05429411
Start Date
April 22 2016
End Date
December 20 2026
Last Update
August 21 2024
Active Locations (1)
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1
Villa Medica Rehabilitation Hospital
Montreal, Canada