Clinical trial NCT06143683: Early Versus Late Upper Extremity Mobilization After Meshed / Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Wound healing measured as percent graft take on POD5 (± 2 days)
timeFrame: From autografting until five days afterwards
Secondary outcomes:
measure: Percent graft healed at POD 14 (± 2 days)
timeFrame: From autografting until 14 days afterwards
measure: Incidence of post-operative local complications (seroma, hematoma, infection, graft loss) or systemic complications (infection, deep vein thrombosis, pulmonary embolism, mortality)
timeFrame: From autografting until 14 days afterwards
measure: Severity of graft site pain
timeFrame: From autografting until five days afterwards
measure: Range of motion of the elbow joint
timeFrame: From autografting until 14 days afterwards
measure: Range of motion of the hand
timeFrame: From autografting until 14 days afterwards
measure: Days to discharge from the Burn Unit
timeFrame: From admission to the burn unit until discharge (approximately 2 days for every 1% total body surface area burn).
measure: Days between admission to the burn unit and the date of discharge.
timeFrame: From admission to the burn unit until discharge (approximately 2 days for every 1% total body surface area burn).
Other outcomes:
Locations:
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Shahriar Shahrokhi, MD
role: PRINCIPAL_INVESTIGATOR
References: