Early Versus Late Upper Extremity Mobilization After Autograft (EXTREMA)

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Burns

Treatments: Other: Early Mobilization; Other: Late Mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04132180

009-2018

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Early mobilization

Experimental group

Treatment:

Other: Early Mobilization

Late mobilization

Active Comparator group

Treatment:

Other: Late Mobilization