An interventional study of Early Mobilization and Late Mobilization in Burns, sponsored by Hamilton Health Sciences Corporation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment
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:
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:
730 studies on the registry are indexed under Burns; 146 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 534 interventional studies indexed under Burns.
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Location:
Exclusion Criteria:
Procedure: Early Mobilization
Procedure: Late 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.
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.
Wound healing measured as percent graft take on POD5 (± 2 days)
Time frame: From autografting until five days afterwards
Percent graft healed at POD 14 (± 2 days)
Photographs used to evaluate the primary and secondary wound healing outcomes will be reviewed by a blinded and trained researcher to estimate the percentage of the grafted area that has healed. The photographs will be taken by a trained member of the Hamilton General Hospital Burn Unit if the patient is admitted, and by a trained member of the burn clinic if the patient is discharged and presenting for follow-up.
Time frame: 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)
Time frame: From autografting until 14 days afterwards
Severity of graft site pain
Patients will self-report graft site pain at rest and with mobilization using the Visual Analogue Pain Scale. The scale is scored from 0 (no pain) to 10 (worst possible pain).
Time frame: From autografting until five days afterwards
Range of motion of the elbow joint
Active range of motion (ROM) for flexion and extension of the elbow will be measured using a goniometer.
Time frame: From autografting until 14 days afterwards
Range of motion of the hand
Active range of motion (ROM) for flexion and extension of the hand joints (metacarpals, IP, PIP, and DIP joints) will be measured using a goniometer.
Time frame: From autografting until 14 days afterwards
Days to discharge from the Burn Unit
The staff physician responsible for the care of the patient in collaboration with the members of the multidisciplinary team will evaluate on a daily basis the patient readiness for discharge based on a list of criteria and determine most appropriate discharge location.
Time frame: From admission to the burn unit until discharge (approximately 2 days for every 1% total body surface area burn).
Days between admission to the burn unit and the date of discharge.
Time frame: From admission to the burn unit until discharge (approximately 2 days for every 1% total body surface area burn).
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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