Scar Management Through Serial Casting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serial casted scar.
- Who it may be relevant to
- Registry conditions: Burn Scar. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Skin Thickness Changes [Time frame: right before intervention, right after intervention, three weeks after intervention]
Secondary outcome measures (5)
- Subjective Scar Satisfaction Level [Time frame: right before intervention, right after intervention, three weeks after intervention]
- Skin Erythema Changes [Time frame: right before intervention, right after intervention, three weeks after intervention]
- Trans-epidermal water loss (TEWL) [Time frame: right before intervention, right after intervention, three weeks after intervention]
- Skin Melanin Changes [Time frame: right before intervention, right after intervention, three weeks after intervention]
- Skin Elasticity Changes [Time frame: right before intervention, right after intervention, three weeks after intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07645664 · 2027-13669