Tailored serial casting intercention for Burn Contracture of Skin

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montreal Burn Unit, Montreal, Canada
Burn Contracture of Skin+2 More
Tailored serial casting intercention - Other
Eligibility
Any Age
All Sexes
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Study Summary

The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in adults and a lack of studies using strong methodological approaches. There are also no studies investigating the effect of casting on hypertrophic scars (HSc) and on self-reported UE function. This study is a longitudinal case series design with a criteria for change on the use of serial casting for the treatment of upper extremity burn contractures. The purpose of this study is to estimate the extent to which range of motion (AROM and PROM), scar characteristics and patient-reported upper-extremity function changes following an individually-tailored serial casting treatment program after switching from one week of usual care and to determine if these changes can be maintained 3 weeks after stopping serial casting, for adult burn survivors who developed an upper-extremity joint contracture greater than 15% normal range of motion within 1-year post-burn. This study will be a longitudinal case series design with a criteria for change. A minimum of 12 participants will be recruited from the "Centre d'expertise pour les victimes de brûlures graves de l'ouest du Québec" (CEVBGOQ) and will undergo one week of "usual care". If the PROM of the joint does not improve after one week of usual care, the participant will start the serial casting process, which will be prescribed by the treating OT. PROM/AROM and scar characteristics will be measured using a revised goniometry protocol that incorporates cutaneokinematics (CKM) principles and precise skin measures (DermaScan C, Cutometer®, Mexameter® and Tewameter®) at baseline, every Monday and Friday of the treatment weeks and 3 weeks after treatment cessation. Self-reported UE function and satisfaction related to scarring will be assessed at baseline and 3 weeks after treatment cessation using the QuickDASH and the patient satisfaction assessment scale (PSAS). Analysis on ROM and scar characteristic will be conducted using a graphical representation with a projected "usual care" regression line to count how many outcomes were over the line once the treatment was introduced. This study will contribute to building evidence for the use of serial casting following UE burn contractures in the adult population.

Eligible Conditions

  • Burn Contracture of Skin

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Baseline, 3 weeks post intervention

Week 3
Patient reported upper-extremity function changes
Scar patient satisfaction
Week 3
Active range of motion changes
Passive range of motion changes
Skin Elasticity Changes
Skin Erythema Changes
Skin Melanin Changes
Skin Thickness Changes
Trans-epidermal water loss (TEWL)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Serial casted joint
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Tailored serial casting intercention · No Placebo Group · N/A

Serial casted joint
Other
Experimental Group · 1 Intervention: Tailored serial casting intercention · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 weeks post intervention

Trial Background

Prof. Bernadette Nedelec, Professor
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Closest Location: Montreal Burn Unit · Montreal, Canada
Photo of montreal  1Photo of montreal  2Photo of montreal  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Burn Contracture of Skin
0 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a fire, flame or scald burn injury.
You have provided informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.