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Serial Casting for Upper Extremity Burn Contractures

Primary Purpose

Burn Contracture of Skin

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tailored serial casting intercention
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Contracture of Skin focused on measuring Burns, Burn Rehabilitation, Serial Casting

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation.
  • Fire, flame or scald burn injury

    -≥16 years old

  • have provided informed consent.

Exclusion Criteria:

  • Frostbite, chemical or electrical burn injury
  • A premorbid musculoskeletal or neurological disorder that limited their ROM
  • Have sustained a neurological injury secondary to the burn injury
  • A psychiatric or cognitive disorder that limits their ability to follow the research protocol
  • Have been diagnosed with heterotopic ossification
  • PROM is contraindicated for any reason
  • Do not understand English or French.

Sites / Locations

  • Hôpital de réadaptation Villa MédicaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Serial casted joint

Arm Description

Tailored serial casting intervention following 1 week of usual care

Outcomes

Primary Outcome Measures

Passive range of motion changes
PROM measures by goniometer (standard and revised goniometry protocol)
Active range of motion changes
AROM measures by goniometer (standard and revised goniometry protocol)

Secondary Outcome Measures

Patient reported upper-extremity function changes
Short version of The Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); A higher score indicates a greater level of disability and severity, whereas, lower scores indicates a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Scar patient satisfaction
Patient satisfaction assessment scale (PSAS), A higher score indicates a lower satisfaction towards the scar. The score ranges from 6 (Very satisfied) to60 (Not satisfied at all).
Skin Thickness Changes
Ultrasound skin measures, mm
Skin Elasticity Changes
Skin elasticity measures (r0- Cutometer), mm
Skin Erythema Changes
Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Skin Melanin Changes
Melanin index measured by Mexameter
Trans-epidermal water loss (TEWL)
Trans-epidermal water loss (TEWL) measured by Tewameter

Full Information

First Posted
June 14, 2022
Last Updated
November 11, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT05425433
Brief Title
Serial Casting for Upper Extremity Burn Contractures
Official Title
Should Serial Casting be a "First-resort" Conservative Treatment for Adults With Upper Extremity Burn Contractures?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
Participants will undergo a tailored intervention based on their needs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Contracture of Skin
Keywords
Burns, Burn Rehabilitation, Serial Casting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serial casted joint
Arm Type
Experimental
Arm Description
Tailored serial casting intervention following 1 week of usual care
Intervention Type
Other
Intervention Name(s)
Tailored serial casting intercention
Intervention Description
Every participant will undergo 1 week of usual care for the affected joint according to the OT's prescription (static progressive, dynamic or serial static) combined with stretching, moisturizers, pressure therapy, or thermal modalities. After the one week of splinting, if the PROM of the targeted joint does not improve, the participant will start serial casting (Monday to Friday). Patients will have a cast applied on Monday morning and worn for 24hrs/day or for 48hrs according to the OTs and treating physician's decision (rationale documented).The OT will decide how many weeks the participant will be wearing casts and the rationale to stop this treatment will be documented. When the treatment is stopped, patients will be encouraged to wear a maintenance splint for the following 2 weeks.
Primary Outcome Measure Information:
Title
Passive range of motion changes
Description
PROM measures by goniometer (standard and revised goniometry protocol)
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Title
Active range of motion changes
Description
AROM measures by goniometer (standard and revised goniometry protocol)
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Secondary Outcome Measure Information:
Title
Patient reported upper-extremity function changes
Description
Short version of The Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); A higher score indicates a greater level of disability and severity, whereas, lower scores indicates a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
Baseline, 3 weeks post intervention
Title
Scar patient satisfaction
Description
Patient satisfaction assessment scale (PSAS), A higher score indicates a lower satisfaction towards the scar. The score ranges from 6 (Very satisfied) to60 (Not satisfied at all).
Time Frame
Baseline, 3 weeks post intervention
Title
Skin Thickness Changes
Description
Ultrasound skin measures, mm
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Title
Skin Elasticity Changes
Description
Skin elasticity measures (r0- Cutometer), mm
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Title
Skin Erythema Changes
Description
Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Title
Skin Melanin Changes
Description
Melanin index measured by Mexameter
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Title
Trans-epidermal water loss (TEWL)
Description
Trans-epidermal water loss (TEWL) measured by Tewameter
Time Frame
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation. Fire, flame or scald burn injury -≥16 years old have provided informed consent. Exclusion Criteria: Frostbite, chemical or electrical burn injury A premorbid musculoskeletal or neurological disorder that limited their ROM Have sustained a neurological injury secondary to the burn injury A psychiatric or cognitive disorder that limits their ability to follow the research protocol Have been diagnosed with heterotopic ossification PROM is contraindicated for any reason Do not understand English or French.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoë Edger-Lacoursière, MSc
Phone
1 (438) 8681804
Email
zoe.edger-lacoursiere@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Nedelec, PhD
Organizational Affiliation
CRCHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de réadaptation Villa Médica
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1C9
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Serial Casting for Upper Extremity Burn Contractures

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