Early Versus Late Upper Extremity Mobilization After Autograft

Burns Clinical Trial

— EXTREMA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04132180
• Other study ID #: 009-2018
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Percent graft take	Post-operative day 5
Secondary	Wound healing	Percent graft take	Post-operative day 14
Secondary	Post-operative clinical outcomes	Elbow range of motion measured using a goniometer.	Post-operative day 5 and 14
Secondary	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
Secondary	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
Secondary	Discharge outcome - disposition	Discharge disposition	Acute hospital stay, up to one year
Secondary	Discharge outcome - readiness	Timing of readiness for discharge.	Acute hospital stay, up to one year
Secondary	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