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Non-silicone Gel Sheet for Burn Scars

N/A
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Must not have
Mechanism of injury is an electrical, chemical, or cold injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1month, 2months, 3months, 1month post intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the efficacy of a non-silicone gel sheet for the treatment of hypertrophic scars. The study will compare the gel sheet to a matched control site.

Who is the study for?
This trial is for burn survivors aged 16 or older with hypertrophic scars from thermal burns, who can understand French or English and have signed the consent form. It's not for those with certain psychiatric illnesses, mature scars, non-thermal burn injuries, allergies to ultrasound gel, keloid scars formation tendencies, or skin conditions like psoriasis near the scar.
What is being tested?
The study tests a non-silicone based gel sheet on one part of a patient's scar compared to an untreated part. It aims to measure changes in scar vascularity, thickness, pain and itchiness over time using precise electronic instruments in a controlled environment at Villa Medica Rehabilitation Hospital.
What are the potential side effects?
There's a small chance (10-25%) that the gel might cause minor redness if instructions aren't followed properly. This side effect typically goes away quickly after removing the gel sheet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 16 or older and was treated for a burn injury at the Montreal Burn Centre.
Select...
My scar is thick and redder than usual, confirmed by a special scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My injury was caused by electricity, chemicals, or cold.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1month, 2months, 3months, 1month post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1month, 2months, 3months, 1month post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Skin Elasticity Changes
Skin Erythema Changes
Skin Thickness Changes
Secondary study objectives
Patient reported treatment efficacy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Gel treated scarExperimental Treatment1 Intervention
Gel treated scar
Group II: Control scarActive Control1 Intervention
No intervention, standard of care

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,484 Total Patients Enrolled
2 Trials studying Burn Scars
55 Patients Enrolled for Burn Scars

Media Library

Non-silicone Gel Sheet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05429411 — N/A
Burn Scars Research Study Groups: Control scar, Gel treated scar
Burn Scars Clinical Trial 2023: Non-silicone Gel Sheet Highlights & Side Effects. Trial Name: NCT05429411 — N/A
Non-silicone Gel Sheet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429411 — N/A
~2 spots leftby Jun 2025
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