Early Versus Late Upper Extremity Mobilization After Meshed / Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients

NCT ID: NCT06143683

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2028-07-31

Brief Summary

STSGs are used to close wounds and minimize infections. After receiving a meshed or sheet split-thickness skin graft (STSG) to the upper extremity or hand for a thermal burn injury, burn surgeons use different methods to improve graft take and reduce complications. This includes different start dates and times for activity.

The goal of this clinical trial is to provide more evidence to improve rehabilitation procedures after STSG operations for patients with burn injuries. The main question[s] it aims to answer are:

• To determine if early mobilization is non-inferior to late mobilization of the upper extremity after meshed STSG with regards to wound healing in adult burn patients.
• To determine if early mobilization is non-inferior to late mobilization of the upper extremity after sheet STSG with regards to wound healing in adult burn patients

Participants will be assigned randomly (like flipping a coin) to one of two groups: early mobilization and late mobilization. Mobilization is the range of motion exercises performed under the supervision of the physical therapy team. Researchers will compare early and late mobilization to see if there are differences in wound healing, range of motion, local and systemic complications, and discharge outcomes.

Participants will be asked to:

• Early mobilization group: begin mobilization of their upper extremity one day after their STSG operation. If their burn includes a graft to your hand, early mobilization of this area will begin three days after their STSG operation.
• Late mobilization group: elevate their elbow in a splint to limit movement until five days after their operation and begin mobilization five days after their STSG operation.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Mobilization

Group Type: EXPERIMENTAL

Early Mobilization

Intervention Type: PROCEDURE

On post-operative day (POD) 1, active range of motion exercises of the elbow joint will be initiated under the observation and guidance of the physical therapy team. On POD 3, the patient will be transitioned to active as well as active-assisted range of motion exercises. The physical therapy team will provide an exercise sheet handout to patients (Appendix 5) and encourage patients to do the exercise for 10 repetitions, 2 times a day, holding each stretch for 30 seconds. On POD3, patients with non-meshed sheet hand grafts will undergo active range of motion exercises of the hands under the observation and guidance of the physical therapy team. On POD 5, the patient will be allowed to move the extremity as tolerated with no restrictions.

Usual Care

Group Type: ACTIVE_COMPARATOR

Late Mobilization

Intervention Type: PROCEDURE

Following surgery, the patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint. From POD 1 to 4, the patient's affected extremity will be kept elevated and immobilized with a flexion blocking splint. On POD 5, the patient will be allowed to move the extremity as tolerated with no restrictions. The physical therapy team will guide the patient on POD5 through range of motion exercises, starting with active, then active assisted, then passive as tolerated.

Interventions

Early Mobilization

On post-operative day (POD) 1, active range of motion exercises of the elbow joint will be initiated under the observation and guidance of the physical therapy team. On POD 3, the patient will be transitioned to active as well as active-assisted range of motion exercises. The physical therapy team will provide an exercise sheet handout to patients (Appendix 5) and encourage patients to do the exercise for 10 repetitions, 2 times a day, holding each stretch for 30 seconds. On POD3, patients with non-meshed sheet hand grafts will undergo active range of motion exercises of the hands under the observation and guidance of the physical therapy team. On POD 5, the patient will be allowed to move the extremity as tolerated with no restrictions.

Intervention Type: PROCEDURE

Late Mobilization

Following surgery, the patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint. From POD 1 to 4, the patient's affected extremity will be kept elevated and immobilized with a flexion blocking splint. On POD 5, the patient will be allowed to move the extremity as tolerated with no restrictions. The physical therapy team will guide the patient on POD5 through range of motion exercises, starting with active, then active assisted, then passive as tolerated.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age: 18 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) and/or sheet split thickness autograft (STSG) applied directly on the wound bed.
• Location:

1. Upper extremity burn - distal to the axilla and proximal to the wrist. The axilla is a difficult area to graft due to its three-dimensional configuration, hence the healing of this area is not comparable to others.

2. The hand that will undergo sheet STSG

Exclusion Criteria

• Injury: Electrical and chemical burn. The pathophysiology of electrical or chemical burns is not comparable to flame or scald burns, hence their exclusion.
• Location: Autograft exclusively to the wrist, axilla, or non-upper extremity. The wrist is a sensitive areas with many joints in close proximity. The loss of graft in this area can be devastating to the patient and will therefore be evaluated only once we have evidence to support the safety of mobilization in upper extremity grafts.
• Patients on vasopressors the day of the operation. Vasopressors cause peripheral vasoconstriction, leading to decreased wound healing capacity. Patients on vasopressors are also usually systemically unwell and should therefore not be included in an elective clinical trial on extremity mobilization.
• Pre-existing comorbidities causing upper extremity mobility restrictions.
• Patient unable to comply with mobilization protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahriar Shahrokhi, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Central Contacts

Shahriar Shahrokhi, MD

Role: CONTACT

Phone: 9055212100

Email: shahrokhi@hhsc.ca

Other Identifiers

16820

Identifier Type: -

Identifier Source: org_study_id