The EXTREMA Trial: The Impact of Early Versus Late Upper Extremity Mobilization After Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Wound healing
Study Overview
Brief Summary
Rationale: There is currently no observational study or randomized clinical trial published evaluating the impact of early versus late mobilization in the upper extremity after split thickness skin autograft. As the current post-operative care protocols vary based on physician preference, evidence is needed to optimize post-operative rehabilitation protocols guided by evidence which optimize wound healing, extremity range of motion, graft site pain, as well as minimize risks of complications and length of stay in hospital.
Objective: To determine if early mobilization is non-inferior to late mobilization of the upper extremity after split thickness skin autograft with regards to wound healing measured as percent graft take on post-operative day 5 in adult burn patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years and older at the time of surgery.
- •Injury: Acute (within 72h of injury) thermal flame or scald burn.
- •Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed.
- •Location: Upper extremity burn - distal to the axilla and proximal to the wrist.
Exclusion Criteria
- •Injury: Electrical and chemical burn.
- •Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity.
- •Patients on vasopressors the day of the operation.
- •Pre-existing comorbidities causing upper extremity mobility restrictions.
- •Patient unable to comply with mobilization protocol.
Outcomes
Primary Outcomes
Wound healing
Time Frame: Post-operative day 5
Percent graft take
Secondary Outcomes
- Wound healing(Post-operative day 14)
- Post-operative complications(Acute hospital stay, up to one year)
- Discharge outcome - disposition(Acute hospital stay, up to one year)
- Discharge outcome - readiness(Acute hospital stay, up to one year)
- Discharge outcome - length of stay(Acute hospital stay, up to one year)
- Post-operative clinical outcomes(Post-operative day 5 and 14)
Investigators
Dr. Shahriar Shahrokhi
Principal Investigator
Sunnybrook Health Sciences Centre