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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1month, 2months, 3months, 1month post intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1month, 2months, 3months, 1month post intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Skin Elasticity Changes

Skin Erythema Changes

Skin Thickness Changes

Secondary outcome measures

Patient reported treatment efficacy

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,601 Total Patients Enrolled

2 Trials studying Burn Scars

84 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants does this trial require?

"Affirmative. Per the information on clinicaltrials.gov, enrolment for this experiment is underway; it was first listed on April 22nd 2016 and last updated June 21st 2022. The research necessitates 36 participants to be recruited from 1 location in total."

Answered by AI

Does this clinical trial enroll individuals aged 25 or older?

"This clinical trial restricts applicants to those between 16 and 100 years old. To accommodate patients younger than 16, there are 21 different trials; for individuals over 65, 70 diverse studies are available."

Answered by AI

Is this experiment still taking on participants?

"Affirmative. Records available on clinicaltrials.gov demonstrate that this experiment is actively recruiting participants, having been initially posted April 22nd 2016. To meet their requirements 36 patients must be sourced from a single location."

Answered by AI

What criteria must an individual meet in order to be eligible for this research?

"This medical investigation is seeking 36 volunteers, aged 16 to 100, who are suffering from burn scars. The research demands that the potential participants meet all of the following criteria: Male or female; any ethnicity; able to comprehend either French or English language; and gave their consent for participation with a signed informed patient form. Additionally, they must exhibit hyperaemic skin thicker than 2.034 mm as measured by high frequency ultrasound through Mexameter erythema index readings exceeding 300."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nonsilicone Gel Sheet for Burn Hypertrophic Scars

Bernadette Nedelec 2016. "Nonsilicone Gel Sheet for Burn Hypertrophic Scars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429411.

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