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

NCT06143683 | Not Yet Recruiting

• 1 other identifier: 16820
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Wound healing measured as percent graft take on POD5 (± 2 days)

  From autografting until five days afterwards

Secondary Outcomes (7)

• Percent graft healed at POD 14 (± 2 days)

  From autografting until 14 days afterwards

• Incidence of post-operative local complications (seroma, hematoma, infection, graft loss) or systemic complications (infection, deep vein thrombosis, pulmonary embolism, mortality)

  From autografting until 14 days afterwards

• Severity of graft site pain

  From autografting until five days afterwards

• Range of motion of the elbow joint

  From autografting until 14 days afterwards

• Range of motion of the hand

  From autografting until 14 days afterwards

Study Arms (2)

Early Mobilization

EXPERIMENTAL

Procedure: Early Mobilization

Usual Care

ACTIVE COMPARATOR

Procedure: Late Mobilization

Interventions

Early Mobilization 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.

Early Mobilization

Late Mobilization 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.

Usual Care

Eligibility Criteria

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

You may qualify if:

• 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:
• 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.
• The hand that will undergo sheet STSG

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

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 Officials

• Shahriar Shahrokhi, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahriar Shahrokhi, MD

CONTACT

9055212100; shahrokhi@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 8, 2023

Record last verified: 2023-12