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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
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
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