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| Name | Class |
|---|---|
| Hôpital de réadaptation Villa Medica, Montreal | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated scar | Experimental | Serial casting treatment |
|
| Control scar | No Intervention | No intervention, standard of care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Thickness Changes | Ultrasound skin thickness (mm) measured by Dermascan | right before intervention, right after intervention, three weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | right before intervention, right after intervention, three weeks after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakub Sawicki, MSc | Contact | 514-288-8201 | 4229 | jakub.sawicki.chum@ssss.gouv.qc.ca |
| Geneviève Schneider, MSc, OT | Contact | 514-288-8201 | genevieve.schneider.vmed@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Bernadette Nedelec, PhD, OT(c) | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 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. |
| right before intervention, right after intervention, three weeks after intervention |
| Trans-epidermal water loss (TEWL) | Trans-epidermal water loss (TEWL) measured by Tewameter. | right before intervention, right after intervention, three weeks after intervention |
| Skin Melanin Changes | Melanin index measured by Mexameter | right before intervention, right after intervention, three weeks after intervention |
| Skin Elasticity Changes | Skin elasticity measures (mm) measured by Cutometer (r0) | right before intervention, right after intervention, three weeks after intervention |