Radial Forearm Donor Site Closure

NCT05740033 | Recruiting

• 1 other identifier: H22-02104
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Oral Cavity Cancer; Donor Site Complication

Keywords

Oral Cancer; Oral Cavity Cancer; Radial Forearm; Donor Site; Surgical Complications

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (9)

• Localized Hematoma at Donor Site

  Patients will be monitored for 6 months post-operatively.

• Donor Site Infection

  Patients will be monitored for 6 months post-operatively.

• Donor Site Wound Dehiscence

  Patients will be monitored for 6 months post-operatively.

• Donor Site Tendon Exposure

  Patients will be monitored for 6 months post-operatively.

• Donor Site Skin Necrosis

  Patients will be monitored for 6 months post-operatively.

Study Arms (2)

STSG arm

ACTIVE COMPARATOR

Patient demographics will be recorded during the enrollment visit. During the participant's surgery in which the radial forearm free flap (RFFF) has been used, surgeons will perform a split-thickness thigh graft to close the forearm donor site. A photograph will be taken of the participants' forearm upon the removal of the dressing and splint. On each of the two follow-up clinic visits, another photo will be taken of the forearm scar and patient-reported outcome questionnaires will be provided for completion.

Procedure: Split-Thickness Skin Graft for Radial Forearm Donor Site Closure

Hatchet flap arm

ACTIVE COMPARATOR

Patient demographics will be recorded during the enrollment visit. The hatchet flap closure of the forearm donor site will be performed following the RFFF's usage. A photograph will be taken of the participants' forearm upon the removal of the dressing and splint. On each of the two follow-up clinic visits, another photo will be taken of the forearm scar and patient-reported outcome questionnaires will be provided for completion.

Procedure: Hatchet Flap for Radial Forearm Donor Site Closure

Interventions

Split-Thickness Skin Graft for Radial Forearm Donor Site Closure PROCEDURE

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.

STSG arm

Hatchet Flap for Radial Forearm Donor Site Closure PROCEDURE

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.

Hatchet flap arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Eitan Prisman, MD, FRCSC

CONTACT

6048754126; eitan.prisman@ubc.ca

Tayo Steininger

CONTACT

6048754111; tstein12@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will become aware of what arm they were randomly assigned to: those in the STSG arm will be to see their additional thigh scar; those in the local flap arm will lack this scar. As such, participants will only be blinded prior to their treatment. The surgeons may not be blinded as they will be performing the procedure on the participants and following up with them as per standard of care post-operatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: February 22, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CA (1)