Burn Scar
Conditions
Keywords
Burns, Burn Rehabilitation, Serial Casting
Brief summary
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
OTHERSerial casted scar
At the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Hôpital de réadaptation Villa Medica, Montreal
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Thickness Changes | right before intervention, right after intervention, three weeks after intervention | Ultrasound skin thickness (mm) measured by Dermascan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Scar Satisfaction Level | right before intervention, right after intervention, three weeks after intervention | 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). |
| Skin Erythema Changes | right before intervention, right after intervention, three weeks after intervention | 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. |
| Trans-epidermal water loss (TEWL) | right before intervention, right after intervention, three weeks after intervention | Trans-epidermal water loss (TEWL) measured by Tewameter. |
| Skin Melanin Changes | right before intervention, right after intervention, three weeks after intervention | Melanin index measured by Mexameter |
| Skin Elasticity Changes | right before intervention, right after intervention, three weeks after intervention | Skin elasticity measures (mm) measured by Cutometer (r0) |
Contacts
CONTACTJakub Sawicki, MSc
CONTACTGeneviève Schneider, MSc, OT
PRINCIPAL_INVESTIGATORBernadette Nedelec, PhD, OT(c)
Centre hospitalier de l'Université de Montréal (CHUM)
Outcome results
None listed