Scar Management Through Serial Casting

ConditionBurn Scar

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16+

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Treated scarExperimental treatment 1 intervention

Group B: Control scarNo intervention 0 interventions

Trial outcomes