Early Versus Late Upper Extremity Mobilization After Autograft

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2022-02-10

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.

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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early mobilization

Group Type EXPERIMENTAL

Early Mobilization

Intervention Type OTHER

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.

Late mobilization

Group Type ACTIVE_COMPARATOR

Late Mobilization

Intervention Type OTHER

The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.

Interventions

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Early 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.

Intervention Type OTHER

Late Mobilization

The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No