Scar Management Through Serial Casting

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Skin Thickness Changes [Срок оценки: right before intervention, right after intervention, three weeks after intervention]

Вторичные конечные точки (5)

• Subjective Scar Satisfaction Level [Срок оценки: right before intervention, right after intervention, three weeks after intervention]
• Skin Erythema Changes [Срок оценки: right before intervention, right after intervention, three weeks after intervention]
• Trans-epidermal water loss (TEWL) [Срок оценки: right before intervention, right after intervention, three weeks after intervention]
• Skin Melanin Changes [Срок оценки: right before intervention, right after intervention, three weeks after intervention]
• Skin Elasticity Changes [Срок оценки: right before intervention, right after intervention, three weeks after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07645664 · 2027-13669

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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