NCT06143683

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

The Impact of Early Versus Late Upper Extremity Mobilization After Meshed / Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2028-05-01
• Completion: 2028-07-01
• First posted: 2023-11-22
• Last updated: 2023-12-08