Radial Forearm Donor Site Closure

Oral Cancer Clinical Trial

Official title:

Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740033
• Other study ID #: H22-02104
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: Eitan Prisman, MD, FRCSC
• Phone: 6048754126
• Email: eitan.prisman[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Donor Site Complication
• Mouth Neoplasms
• Oral Cancer
• Oral Cavity Cancer

Intervention

Procedure:
• Split-Thickness Skin Graft for Radial Forearm Donor Site Closure
This method is performed by harvesting a 0.014-inch skin graft harvested from the anterolateral thigh on the side of the RFFF to reconstruct the forearm donor site. This skin graft is then used to cover the donor defect. The skin graft is sutured in place with 4-0 chromic suture, and a standard bolster dressing will be applied, and a partial splint will be left in place for five days post-operation.
• Hatchet Flap for Radial Forearm Donor Site Closure
The hatchet flap closures will be performed based on prior description by Lane et al. (12), except no drain is placed in situ. A back cut of 3 to 4 cm is made to aid closure (Figure 1). Tension will be minimized by maintaining the wrist in flexion. A mepore dressing will be applied to the donor site post-operatively for two days.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Michigan Hand Outcomes Questionnaire (MHOQ) Measure	A questionnaire that measures symptoms, function, aesthetics, and patient satisfaction in regards to the function of their hands. Responses are recorded on a 5-point Likert scale ranging from very good (1) to very poor (5).	Measure documented at 1 month post-surgery.
Primary	Second MHOQ Measure	A questionnaire that measures symptoms, function, aesthetics, and patient satisfaction in regards to the function of their hands. Responses are recorded on a 5-point Likert scale ranging from very good (1) to very poor (5).	Measure documented between 3-6 months post-surgery.
Primary	First Patient and Observer Scale Assessment Scale (POSAS) Measure	A questionnaire measuring both the patient's aesthetic perception and the trial coordinator's aesthetic and physical assessment of the scar formation along the donor site wound. Responses to questions are measured on a 10-point Likert scale ranging from the worst scarring imaginable (10) to the best scar imaginable (feels like normal skin, not scar tissue; 1).	Measure documented at 1 month post-surgery.
Primary	Second POSAS Measure	A questionnaire measuring both the patient's aesthetic perception and the trial coordinator's aesthetic and physical assessment of the scar formation along the donor site wound. Responses to questions are measured on a 10-point Likert scale ranging from the worst scarring imaginable (10) to the best scar imaginable (feels like normal skin, not scar tissue; 1).	Measure documented between 3-6 months post-surgery.
Primary	First Decision Regret Scale (DRS) Measure	A questionnaire measuring a patient's decisional regret related to receiving the surgery. Responses are measured on a 5-point Likert scale, ranging from extreme decisional regret (5) to no decisional regret (1).	Measure documented at 1 month post-surgery.
Primary	Second DRS Measure	A questionnaire measuring a patient's decisional regret related to receiving the surgery. Responses are measured on a 5-point Likert scale, ranging from extreme decisional regret (5) to no decisional regret (1).	Measure documented between 3-6 months post-surgery.
Secondary	Localized Hematoma at Donor Site	A severe pooling of blood at the donor site.	Patients will be monitored for 6 months post-operatively.
Secondary	Donor Site Infection	Infection at the donor site or anywhere along the forearm scar.	Patients will be monitored for 6 months post-operatively.
Secondary	Donor Site Wound Dehiscence	A re-opening of the donor site wound.	Patients will be monitored for 6 months post-operatively.
Secondary	Donor Site Tendon Exposure	Exposure of the forearm tendons at the donor site.	Patients will be monitored for 6 months post-operatively.
Secondary	Donor Site Skin Necrosis	Significant amount of dead or dying skin tissue overlying or abutting the donor site and scar.	Patients will be monitored for 6 months post-operatively.
Secondary	Donor Site Contractures	A persistent tightening or contraction of skin, ligaments, tendons, or muscles at the forearm donor site.	Patients will be monitored for 6 months post-operatively.
Secondary	Keloid Scarring at Donor Site Wound	Excessive scar tissue formation along the donor site wound.	Patients will be monitored for 6 months post-operatively.
Secondary	Divot Formation into Skin at Donor Site	Visible and persistent depressions into the skin surface of the forearm.	Patients will be monitored for 6 months post-operatively.
Secondary	Skin Graft Irregularities at Donor Site	Additional irregularities such as bumps, roughness, or changes to colour will be recorded.	Patients will be monitored for 6 months post-operatively.