Early Versus Late Upper Extremity Mobilization After Autograft (EXTREMA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Burns
• Intervention / Treatment: Other: Early Mobilization; Other: Late Mobilization

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early mobilization	Other: 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.
ACTIVE_COMPARATOR: Late mobilization	Other: Late Mobilization; The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2018
• Primary Completion (ACTUAL): February 10, 2022
• Study Completion (ACTUAL): February 10, 2022

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 009-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No