Early Versus Late Upper Extremity Mobilization After Autograft

Not Applicable

Terminated

• Conditions: Burns
• Interventions: Other: Late Mobilization; Other: Early Mobilization

• Registration Number: NCT04132180
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-14
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Status Verified: 2022-02
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late mobilization	Late Mobilization	-
Early mobilization	Early Mobilization	-

Primary Outcome Measures

Name	Time	Method
Wound healing	Post-operative day 5	Percent graft take

Secondary Outcome Measures

Name	Time	Method
Post-operative clinical outcomes	Post-operative day 5 and 14	Graft site pain measured using visual analogue scale (0 - no pain to 10 - worst possible pain)
Wound healing	Post-operative day 14	Percent graft take
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).
Discharge outcome - disposition	Acute hospital stay, up to one year	Discharge disposition
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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada