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Scar Management Through Serial Casting

NCT07645664 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-06-12

No results posted yet for this study

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

Interventions

OTHER

Serial casted scar

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

Sponsors & Collaborators

  • Hôpital de réadaptation Villa Medica, Montreal

    collaborator UNKNOWN

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Bernadette Nedelec, PhD, OT(c) · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-11-30
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645664 on ClinicalTrials.gov