Burn ScarNCT05429411
Nonsilicone Gel Sheet for Burn Hypertrophic Scars
A study testing Silicone gel in people with Burn Scar, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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 Cochrane review of the data concluded that the trials were of poor quality therefore only provided weak evidence for their… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Burn Scar
- What is being tested?
- Silicone gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2016to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Within-patient Study to Evaluate the Efficacy of a Nonsilicone Gel Sheet for the Treatment of Hypertrophic Scar in Adult Burn Survivors
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 Cochrane review of the data concluded that the trials were of poor quality therefore only provided weak evidence for their benefit. One of the limitations of previous studies has been the subjectivity and potential bias of the evaluation tools that were used. The validation of electronic instrumentation for the measurement of hypertrophic scar and determination of their superior clinometric properties provides the basis from which precise, systematic, evaluations can now be performed that will allow for confident conclusions to be made. Thus, the objective of this study is to evaluate the efficacy of a non-silicone gel sheet relative to a patient-matched control site in a prospective, randomized, controlled, within-patient study. This study has been piloted and the data used to establish the number of participants that will be required for an adequately powered study.
Specific Objectives:
Read more
- To characterize the changes in vascularity, thickness, pain and itch in adult burn hypertrophic scar (HSc) following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars.
- To characterize the changes in pliability of adult burn HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars.
Recruitment: Burn survivors aged 14 years and more, who have developed HSc and are being treated at CHUM and Villa Medica Rehabilitation Hospital.
Risks: There is a minimal risk that the gel used in this project might cause minor redness (10-25% if the use instructions are not followed). The rash quickly resolves once the gel sheet is removed.
Study Site: This study will be carried out at Villa Medica Rehabilitation Hospital.
Read the 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 progression has been completed the gel sheet will be applied daily by the subjects for as close to 21+ hours as possible.
- Conditions
- Burn Scar
- Being tested
- Silicone gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone gelOther
At the selected treatment sites the 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 progression has been completed the gel sheet will be applied daily by the subjects for as close to 21+ hours as possible. The gel will be removed for exercise and treatment interventions as well as personal hygiene
| Study group | Role | What they receive |
|---|---|---|
| Gel treated scar | Experimental | Gel treated scar Receives: Other: Silicone gel |
| Control scar | No intervention | No intervention, standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Erythema Changes
Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Measured: Baseline, 1month, 2months, 3months, 1month post intervention
Skin Elasticity Changes
Skin elasticity measures (r0- cutometer), mm
Measured: Baseline, 1month, 2months, 3months, 1month post intervention
Skin Thickness Changes
Ultrasound skin measures, mm
Measured: Baseline, 1month, 2months, 3months, 1month post intervention
Secondary outcomes (1)
Patient reported treatment efficacy
Visual analog scale (score 0-none to 10-worse)
Measured: Baseline, 1month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start22 Apr 2016
- Primary completion20 Jun 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429411
- Sponsor's protocol ID
- 15.386
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nedelec B, Edger-Lacoursiere Z, Calva V, Sawicki J, Marois-Page E, Jean S, Schneider G, Malo-Leclerc I, Shashoua D, Correa JA. Within-Patient, Evaluator-Blinded, Randomized Controlled Clinical Trial to Assess the Efficacy of Gel Sheets in the Treatment of Hypertrophic Scar in Adult Burn Survivors. J Burn Care Res. 2026 Jan 6;47(1):255-265. doi: 10.1093/jbcr/iraf151.
PubMed 40747996
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Within-patient Study to Evaluate the Efficacy of a Nonsilicone Gel Sheet for the Treatment of Hypertrophic Scar in Adult Burn Survivors
- ClinicalTrials.gov ID
- NCT05429411
- Acronym / sponsor ID
- 15.386
- Conditions
- Burn Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Cochrane review of the data concluded that the trials were of poor quality therefore only provided weak evidence for their benefit. One of the limitations of previous studies has been the subjectivity and potential bias of the evaluation tools that were used. The validation of electronic instrumentation for the measurement of hypertrophic scar and determination of their superior clinometric properties provides the basis from which precise, systematic, evaluations can now be performed that will allow for confident conclusions to be made. Thus, the objective of this study is to evaluate the efficacy of a non-silicone gel sheet relative to a patient-matched control site in a prospective, randomized, controlled, within-patient study. This study has been piloted and the data used to establish the number of participants that will be required for an adequately powered study.
Specific Objectives:
- To characterize the changes in vascularity, thickness, pain and itch in adult burn hypertrophic scar (HSc) following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars.
- To characterize the changes in pliability of adult burn HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars.
Recruitment: Burn survivors aged 14 years and more, who have developed HSc and are being treated at CHUM and Villa Medica Rehabilitation Hospital.
Risks: There is a minimal risk that the gel used in this project might cause minor redness (10-25% if the use instructions are not followed). The rash quickly resolves once the gel sheet is removed.
Study Site: This study will be carried out at Villa Medica Rehabilitation Hospital.
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 progression has been completed the gel sheet will be applied daily by the subjects for as close to 21+ hours as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel treated scar | Experimental | Other: Silicone gelGel treated scar |
| Control scar | No intervention | –No intervention, standard of care |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone gelAt the selected treatment sites the 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 progression has been completed the gel sheet will be applied daily by the subjects for as close to 21+ hours as possible. The gel will be removed for exercise and treatment interventions as well as personal hygiene | Other | Gel treated scar |
Primary outcome
Skin Erythema Changes
Time frame: Baseline, 1month, 2months, 3months, 1month post intervention
Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Skin Elasticity Changes
Time frame: Baseline, 1month, 2months, 3months, 1month post intervention
Skin elasticity measures (r0- cutometer), mm
Skin Thickness Changes
Time frame: Baseline, 1month, 2months, 3months, 1month post intervention
Ultrasound skin measures, mm
1 secondary outcome
Patient reported treatment efficacy
Time frame: Baseline, 1month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 40747996Nedelec B, Edger-Lacoursiere Z, Calva V, Sawicki J, Marois-Page E, Jean S, Schneider G, Malo-Leclerc I, Shashoua D, Correa JA. Within-Patient, Evaluator-Blinded, Randomized Controlled Clinical Trial to Assess the Efficacy of Gel Sheets in the Treatment of Hypertrophic Scar in Adult Burn Survivors. J Burn Care Res. 2026 Jan 6;47(1):255-265. doi: 10.1093/jbcr/iraf151.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone gel in people with Burn Scar, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Erythema Changes (time frame: Baseline, 1month, 2months, 3months, 1month post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05429411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.