An interventional study of Serial casted scar in Burn Scar, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 38 is close to the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serial casting treatment
Other: Serial casted scar
No intervention, standard of care only.
At the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days.
Skin Thickness Changes
Ultrasound skin thickness (mm) measured by Dermascan
Time frame: right before intervention, right after intervention, three weeks after intervention
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).
Time frame: 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.
Time frame: right before intervention, right after intervention, three weeks after intervention
Trans-epidermal water loss (TEWL)
Trans-epidermal water loss (TEWL) measured by Tewameter.
Time frame: right before intervention, right after intervention, three weeks after intervention
Skin Melanin Changes
Melanin index measured by Mexameter
Time frame: right before intervention, right after intervention, three weeks after intervention
Skin Elasticity Changes
Skin elasticity measures (mm) measured by Cutometer (r0)
Time frame: right before intervention, right after intervention, three weeks after intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Nov 2028, 29 months later.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 29 months is above that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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