Scar Management Through Serial Casting

NCT07645664 | Not Yet Recruiting

• 1 other identifier: 2027-13669
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Burn Scar

Keywords

Burns; Burn Rehabilitation; Serial Casting

Outcome Measures

Primary Outcomes (1)

• Skin Thickness Changes

  Ultrasound skin thickness (mm) measured by Dermascan

  right before intervention, right after intervention, three weeks after intervention

Secondary Outcomes (5)

• Subjective Scar Satisfaction Level

  right before intervention, right after intervention, three weeks after intervention

• Skin Erythema Changes

  right before intervention, right after intervention, three weeks after intervention

• Trans-epidermal water loss (TEWL)

  right before intervention, right after intervention, three weeks after intervention

• Skin Melanin Changes

  right before intervention, right after intervention, three weeks after intervention

• Skin Elasticity Changes

  right before intervention, right after intervention, three weeks after intervention

Study Arms (2)

Treated scar

EXPERIMENTAL

Serial casting treatment

Other: Serial casted scar

Control scar

NO INTERVENTION

No intervention, standard of care only.

Interventions

Serial casted scar OTHER

At the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days.

Treated scar

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Hôpital de réadaptation Villa Medica, Montreal: collaborator

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Bernadette Nedelec, PhD, OT(c)

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub Sawicki, MSc

CONTACT

514-288-8201; jakub.sawicki.chum@ssss.gouv.qc.ca

Geneviève Schneider, MSc, OT

CONTACT

514-288-8201; genevieve.schneider.vmed@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, McGill University

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share