Early Versus Late Upper Extremity Mobilization After Autograft

NCT04132180 | Terminated

• 1 other identifier: 009-2018
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Percent graft take

  Post-operative day 5

Secondary Outcomes (7)

• Wound healing

  Post-operative day 14

• Post-operative clinical outcomes

  Post-operative day 5 and 14

• Post-operative clinical outcomes

  Post-operative day 5 and 14

• Post-operative complications

  Acute hospital stay, up to one year

• Discharge outcome - disposition

  Acute hospital stay, up to one year

Study Arms (2)

Early mobilization

EXPERIMENTAL

Other: Early Mobilization

Late mobilization

ACTIVE COMPARATOR

Other: Late Mobilization

Interventions

Early Mobilization 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.

Early mobilization

Late Mobilization OTHER

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

Late mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older at the time of surgery.
• Injury: Acute (within 72h of injury) thermal flame or scald burn.
• Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed.
• Location: Upper extremity burn - distal to the axilla and proximal to the wrist.

You may not qualify if:

• Injury: Electrical and chemical burn.
• Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity.
• Patients on vasopressors the day of the operation.
• Pre-existing comorbidities causing upper extremity mobility restrictions.
• Patient unable to comply with mobilization protocol.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Burns

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 18, 2019
• Study Start: August 14, 2018
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CA (1)