Burns
Conditions
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.
Interventions
OTHEREarly Mobilization
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.
OTHERLate Mobilization
The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years and older at the time of surgery. 2. Injury: Acute (within 72h of injury) thermal flame or scald burn. 3. Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed. 4. Location: Upper extremity burn - distal to the axilla and proximal to the wrist.
Exclusion criteria
1. Injury: Electrical and chemical burn. 2. Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity. 3. Patients on vasopressors the day of the operation. 4. Pre-existing comorbidities causing upper extremity mobility restrictions. 5. Patient unable to comply with mobilization protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | Post-operative day 5 | Percent graft take |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative clinical outcomes | Post-operative day 5 and 14 | Elbow range of motion measured using a goniometer. |
| Post-operative complications | Acute hospital stay, up to one year | Local complications (seroma, hematoma, infection, graft loss) and systemic complications (infection, deep vein thrombosis, pulmonary embolism, myocardial infarction, mortality). |
| Wound healing | Post-operative day 14 | Percent graft take |
| Discharge outcome - readiness | Acute hospital stay, up to one year | Timing of readiness for discharge. |
| Discharge outcome - length of stay | Acute hospital stay, up to one year | Length of stay in hospital. From date of admission to date of discharge. |
| Discharge outcome - disposition | Acute hospital stay, up to one year | Discharge disposition |
Countries
Canada
Outcome results
None listed