- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740033
Radial Forearm Donor Site Closure
Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Harkaran S Dial
- Phone Number: 22935 6048754111
- Email: harkaran.dial@vch.ca
Study Contact Backup
- Name: Eitan Prisman, MD, FRCSC
- Phone Number: 6048754126
- Email: eitan.prisman@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital
-
Contact:
- Diane Pan
- Phone Number: 22935 (604) 875-4111
- Email: diane.pan@vch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: STSG arm
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. |
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.
|
Active Comparator: Hatchet flap arm
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
First Michigan Hand Outcomes Questionnaire (MHOQ) Measure
Time Frame: Measure documented at 1 month post-surgery.
|
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
Time Frame: Measure documented between 3-6 months post-surgery.
|
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
Time Frame: Measure documented at 1 month post-surgery.
|
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
Time Frame: Measure documented between 3-6 months post-surgery.
|
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
Time Frame: Measure documented at 1 month post-surgery.
|
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
Time Frame: Measure documented between 3-6 months post-surgery.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Localized Hematoma at Donor Site
Time Frame: Patients will be monitored for 6 months post-operatively.
|
A severe pooling of blood at the donor site.
|
Patients will be monitored for 6 months post-operatively.
|
Donor Site Infection
Time Frame: Patients will be monitored for 6 months post-operatively.
|
Infection at the donor site or anywhere along the forearm scar.
|
Patients will be monitored for 6 months post-operatively.
|
Donor Site Wound Dehiscence
Time Frame: Patients will be monitored for 6 months post-operatively.
|
A re-opening of the donor site wound.
|
Patients will be monitored for 6 months post-operatively.
|
Donor Site Tendon Exposure
Time Frame: Patients will be monitored for 6 months post-operatively.
|
Exposure of the forearm tendons at the donor site.
|
Patients will be monitored for 6 months post-operatively.
|
Donor Site Skin Necrosis
Time Frame: Patients will be monitored for 6 months post-operatively.
|
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.
|
Donor Site Contractures
Time Frame: Patients will be monitored for 6 months post-operatively.
|
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.
|
Keloid Scarring at Donor Site Wound
Time Frame: Patients will be monitored for 6 months post-operatively.
|
Excessive scar tissue formation along the donor site wound.
|
Patients will be monitored for 6 months post-operatively.
|
Divot Formation into Skin at Donor Site
Time Frame: Patients will be monitored for 6 months post-operatively.
|
Visible and persistent depressions into the skin surface of the forearm.
|
Patients will be monitored for 6 months post-operatively.
|
Skin Graft Irregularities at Donor Site
Time Frame: Patients will be monitored for 6 months post-operatively.
|
Additional irregularities such as bumps, roughness, or changes to colour will be recorded.
|
Patients will be monitored for 6 months post-operatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-02104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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