Burn ScarNCT07645664
Scar Management Through Serial Casting
A study testing Serial casted scar in people with Burn Scar, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial summary
Scar management remains one of the major clinical challenges for burn survivors with hypertrophic scars. Beyond their visible appearance, hypertrophic scars can significantly impair physical function, reduce life satisfaction, and affect overall quality of life. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Burn Scar
- What is being tested?
- Serial casted scar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult burn survivors who have two scars that meet the diagnostic criteria of a HSc (erythema index greater than 300 and thickness greater than 2.034 mm) and with no more than 0.5 mm thickness difference between each other;
- are proficient in English and/or French;
- provide informed consent.
Who cannot join
- patients who sustained electrical or cold injury;
- formed keloid scars or have only mature scars (erythema index less than 300);
- have a a dermatological condition that could interfere with measurement reliability (eczema, psoriasis);
- have a cognitive/psychiatric condition that could impaired understanding of the consent process or adherence to protocol procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Scar management remains one of the major clinical challenges for burn survivors with hypertrophic scars. Beyond their visible appearance, hypertrophic scars can significantly impair physical function, reduce life satisfaction, and affect overall quality of life. According to the results of a recently completed study, the application of serial casts appears promising for the treatment of hypertrophic scars in adults who have survived a burn injury. However, this therapeutic approach has not yet been evaluated objectively in terms of scar characteristics within the context of a study with sufficient statistical power. The present project is the first study with sufficient statistical power to objectively evaluate the beneficial effects of serial casting on the characteristics of hypertrophic scars in adult burn survivors. The objective of this study is to characterize changes in thickness, elasticity, vascularization, transepidermal water loss (TEWL), itching, and pain in hypertrophic burn scars in adults after one week of treatment with serial dressings, compared to an intra-individual control scar. Our hypothesis is that relative to baseline measures the scar thickness (primary outcome), erythema index, TEWL, itch, and pain will decrease at treatment sites compared to control sites. Conversely, elasticity will increase at the treatment sites compared to control sites. This will be a prospective, longitudinal, evaluator-blinded, randomized intra-individual controlled trial.
Read the detailed description
This will be a prospective, longitudinal, evaluator-blinded, randomized intra-individual controlled trial. Participants will start serial casting on selected scars during 7 days for 24 hrs/day. The objective scar characteristics and the subjective scar quality appreciation level will be evaluated immediately before and immediately after serial casting, and then 3 weeks after the cast has been removed.
- Conditions
- Burn Scar
- Being tested
- Serial casted scar
- Keywords
- Burns, Burn Rehabilitation, Serial Casting
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial casted scarOther
At the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Treated scar | Experimental | Serial casting treatment Receives: Other: Serial casted scar |
| Control scar | No intervention | No intervention, standard of care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Thickness Changes
Ultrasound skin thickness (mm) measured by Dermascan
Measured: right before intervention, right after intervention, three weeks after intervention
Secondary outcomes (5)
Subjective Scar Satisfaction Level
Subjective Scar Satisfaction Level evaluated by POSAS (Patient and Observer Scar Assessment Scale) v. 2.0 modified; visual analog scale (score 0-identical to- 10-very different from normal skin).
Measured: right before intervention, right after intervention, three weeks after intervention
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 skin type. The measurements are generally used to determine changes before and after a treatment.
Measured: right before intervention, right after intervention, three weeks after intervention
Trans-epidermal water loss (TEWL)
Trans-epidermal water loss (TEWL) measured by Tewameter.
Measured: right before intervention, right after intervention, three weeks after intervention
Skin Melanin Changes
Melanin index measured by Mexameter
Measured: right before intervention, right after intervention, three weeks after intervention
Skin Elasticity Changes
Skin elasticity measures (mm) measured by Cutometer (r0)
Measured: right before intervention, right after intervention, three weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital de réadaptation Villa Medica, Montreal
- Responsible party
- Principal investigator, Bernadette Nedelec, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Bernadette Nedelec, PhD, OT(c), Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645664
- Sponsor's protocol ID
- 2027-13669
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Management Through Serial Casting
- ClinicalTrials.gov ID
- NCT07645664
- Acronym / sponsor ID
- 2027-13669
- Conditions
- Burn Scar
- Keywords
- Burns, Burn Rehabilitation, Serial Casting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Hôpital de réadaptation Villa Medica, Montreal
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 12 Jun 2026 (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.
Scar management remains one of the major clinical challenges for burn survivors with hypertrophic scars. Beyond their visible appearance, hypertrophic scars can significantly impair physical function, reduce life satisfaction, and affect overall quality of life. According to the results of a recently completed study, the application of serial casts appears promising for the treatment of hypertrophic scars in adults who have survived a burn injury. However, this therapeutic approach has not yet been evaluated objectively in terms of scar characteristics within the context of a study with sufficient statistical power. The present project is the first study with sufficient statistical power to objectively evaluate the beneficial effects of serial casting on the characteristics of hypertrophic scars in adult burn survivors. The objective of this study is to characterize changes in thickness, elasticity, vascularization, transepidermal water loss (TEWL), itching, and pain in hypertrophic burn scars in adults after one week of treatment with serial dressings, compared to an intra-individual control scar. Our hypothesis is that relative to baseline measures the scar thickness (primary outcome), erythema index, TEWL, itch, and pain will decrease at treatment sites compared to control sites. Conversely, elasticity will increase at the treatment sites compared to control sites. This will be a prospective, longitudinal, evaluator-blinded, randomized intra-individual controlled trial.
Detailed description
This will be a prospective, longitudinal, evaluator-blinded, randomized intra-individual controlled trial. Participants will start serial casting on selected scars during 7 days for 24 hrs/day. The objective scar characteristics and the subjective scar quality appreciation level will be evaluated immediately before and immediately after serial casting, and then 3 weeks after the cast has been removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated scar | Experimental | Other: Serial casted scarSerial casting treatment |
| Control scar | No intervention | –No intervention, standard of care only. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- adult burn survivors who have two scars that meet the diagnostic criteria of a HSc (erythema index greater than 300 and thickness greater than 2.034 mm) and with no more than 0.5 mm thickness difference between each other;
- are proficient in English and/or French;
- provide informed consent.
Key exclusion criteria (4 listed)
- patients who sustained electrical or cold injury;
- formed keloid scars or have only mature scars (erythema index less than 300);
- have a a dermatological condition that could interfere with measurement reliability (eczema, psoriasis);
- have a cognitive/psychiatric condition that could impaired understanding of the consent process or adherence to protocol procedures.
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 |
|---|---|---|
| Serial casted scarAt the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days. | Other | Treated scar |
Primary outcome
Skin Thickness Changes
Time frame: right before intervention, right after intervention, three weeks after intervention
Ultrasound skin thickness (mm) measured by Dermascan
5 secondary outcomes
Subjective Scar Satisfaction Level
Time frame: right before intervention, right after intervention, three weeks after intervention
Skin Erythema Changes
Time frame: right before intervention, right after intervention, three weeks after intervention
Trans-epidermal water loss (TEWL)
Time frame: right before intervention, right after intervention, three weeks after intervention
Skin Melanin Changes
Time frame: right before intervention, right after intervention, three weeks after intervention
Skin Elasticity Changes
Time frame: right before intervention, right after intervention, three weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
Bernadette Nedelec, PhD, OT(c) principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Questions about this trial
What is this clinical trial studying?
A study testing Serial casted scar in people with Burn Scar, run by Centre hospitalier de l'Université de Montréal (CHUM).
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakub Sawicki, MSc (514-288-8201 ext. 4229, jakub.sawicki.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Thickness Changes (time frame: right before intervention, right after intervention, three weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.