Clinical trial NCT05740033: Radial Forearm Donor Site Closure
Official title: Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Cancer
Oral Cavity Cancer
Donor Site Complication
Keywords: Oral Cancer
Oral Cavity Cancer
Radial Forearm
Donor Site
Surgical Complications
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have two arms: one with participants receiving a split-thickness skin graft from the thigh to close the radial forearm donor site, and the other using a local (hatchet) flap to close this site. These two arms will be populated randomly and in parallel.
Primary purpose: TREATMENT

Brief summary: The radial forearm free flap (RFFF) is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction. Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site, two of which are the split-thickness skin graft (STSG), taken from the thigh, and the hatchet flap, which uses a local flap within the radial forearm. This RCT will determine whether retrospectively reported improvements to aesthetic and functional outcomes for STSG patients are greater compared to hatchet flap patients.

Detailed description: The radial forearm free flap (RFFF), introduced by Yang et al. in 1981, is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction. Since the survival rate of the RFFF has reached more than 95%, the clinical focus has gradually shifted to the postoperative quality of life, particularly in terms of donor site morbidity.

Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site of a RFFF. Many possibilities of donor site closures have been described, ranging from direct closure to skin grafting, tissue expansion, use of acellular dermal matrix and local flaps. Each of these techniques has its own advantages and drawbacks and the debate regarding the optimal method for closing the RFFF donor site continues.

Split-thickness skin graft (STSG) is a very thin strip of skin that is typically taken from the upper thigh and is the most commonly used method to cover the forearm after taking the RFFF. Advantages of this technique include reducing the amount of tension that is on the forearm which may lead to a better scar and better mobility while disadvantages include the need of an additional scar on the thigh and possible mismatch of the color of the skin graft when compared to the forearm.

Due to these potential limitations, surgeons have attempted to close the forearm directly by means of local flaps, which use nearby skin, soft tissue, and blood vessels to cover the forearm. The hatchet flap is a triangular local rotation flap, first described by Emmet in 1977, with a greater or lesser degree of advancement and with a back cut at the base of the flap through which it derives its vascular supply. This method may allow for quicker wound healing by primary intention and improved coverage of the tendons which should theoretically decrease donor site morbidity; however, since only tissue from the forearm is used this may lead to increased tension and therefore increased scar formation.

Risks and complications for both types of closure are the same which include bleeding, infection, hypertrophic scars, tendon exposure, divot formation, irregular skin graft surface, prolonged wound healing, and loss of skin graft. There are only a few studies on the functional and visual outcomes of forearm closure after RFFF removal using the hatchet flap or similar local flaps, warranting the need for further studies on these closure techniques.

It is hypothesized that donor site closure using the STSG flap will result in greater functional and aesthetic outcomes for the radial forearm donor site as measured by an improved scores to the 3 given questionnaires. Post-operative complication rates are also hypothesized to be lower for STSG flap closure when compared to hatchet flap closure.

The literature currently remains in a state of clinical equipoise, and at the study site (Vancouver General Hospital) the STSG and hatchet flap are the two most common methods of donor site closure. Based on a retrospective data analysis at the study site, functional and patient-reported scar aesthetic outcomes were improved for STSG flap closure patients when compared to hatchet flap patients. As a retrospective analysis, objective assessments of the scar could not be performed, nor could the immediate post-operative outcomes be taken and compared over a consistent post-operative time frame schedule. This study aims to address this knowledge gap by conducting a parallel-group randomized controlled trial for the study site's two common donor site closure techniques, STSG and hatchet flap.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 or older
* Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction

Exclusion Criteria:

* Serious medical comorbidities including metastatic disease or other contraindications to surgery
* Any pre-existing condition affecting the use of both hands, including previous major scars
* Unable or unwilling to complete post-operative questionnaires in English
* Pregnant or lactating women

Primary outcomes:
measure: First Michigan Hand Outcomes Questionnaire (MHOQ) Measure
timeFrame: Measure documented at 1 month post-surgery.
measure: Second MHOQ Measure
timeFrame: Measure documented between 3-6 months post-surgery.
measure: First Patient and Observer Scale Assessment Scale (POSAS) Measure
timeFrame: Measure documented at 1 month post-surgery.
measure: Second POSAS Measure
timeFrame: Measure documented between 3-6 months post-surgery.
measure: First Decision Regret Scale (DRS) Measure
timeFrame: Measure documented at 1 month post-surgery.
measure: Second DRS Measure
timeFrame: Measure documented between 3-6 months post-surgery.
Secondary outcomes:
measure: Localized Hematoma at Donor Site
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Donor Site Infection
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Donor Site Wound Dehiscence
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Donor Site Tendon Exposure
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Donor Site Skin Necrosis
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Donor Site Contractures
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Keloid Scarring at Donor Site Wound
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Divot Formation into Skin at Donor Site
timeFrame: Patients will be monitored for 6 months post-operatively.
measure: Skin Graft Irregularities at Donor Site
timeFrame: Patients will be monitored for 6 months post-operatively.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References: