Early Versus Late Upper Extremity Mobilization After Autograft

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Burns

Intervention / Treatment
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* Other: Early Mobilization
* Other: Late Mobilization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilization<br> | Other: Early Mobilization<br>* Range of motion exercises of the upper extremity will be performed under the guidance of the physical therapy team starting on post-operative day 1.<br>|
| Active Comparator: Late mobilization<br> | Other: Late Mobilization<br>* The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Percent graft take | Post-operative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Percent graft take | Post-operative day 14 | 
| Post-operative clinical outcomes | Elbow range of motion measured using a goniometer. | Post-operative day 5 and 14 | 
| Post-operative clinical outcomes | Graft site pain measured using visual analogue scale (0 - no pain to 10 - worst possible pain) | Post-operative day 5 and 14 | 
| Post-operative complications | Local complications (seroma, hematoma, infection, graft loss) and systemic complications (infection, deep vein thrombosis, pulmonary embolism, myocardial infarction, mortality). | Acute hospital stay, up to one year | 
| Discharge outcome - disposition | Discharge disposition | Acute hospital stay, up to one year | 
| Discharge outcome - readiness | Timing of readiness for discharge. | Acute hospital stay, up to one year | 
| Discharge outcome - length of stay | Length of stay in hospital. From date of admission to date of discharge. | Acute hospital stay, up to one year |