Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- First Decision Regret Scale (DRS) Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 or older
- •Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction
排除标准
- •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
结局指标
主要结局
First Decision Regret Scale (DRS) Measure
时间窗: 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).
First Patient and Observer Scale Assessment Scale (POSAS) Measure
时间窗: 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).
First Michigan Hand Outcomes Questionnaire (MHOQ) Measure
时间窗: 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).
Second MHOQ Measure
时间窗: 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).
Second POSAS Measure
时间窗: 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).
Second DRS Measure
时间窗: 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).
次要结局
- Donor Site Wound Dehiscence(Patients will be monitored for 6 months post-operatively.)
- Donor Site Skin Necrosis(Patients will be monitored for 6 months post-operatively.)
- Localized Hematoma at Donor Site(Patients will be monitored for 6 months post-operatively.)
- Donor Site Tendon Exposure(Patients will be monitored for 6 months post-operatively.)
- Donor Site Contractures(Patients will be monitored for 6 months post-operatively.)
- Skin Graft Irregularities at Donor Site(Patients will be monitored for 6 months post-operatively.)
- Donor Site Infection(Patients will be monitored for 6 months post-operatively.)
- Divot Formation into Skin at Donor Site(Patients will be monitored for 6 months post-operatively.)
- Keloid Scarring at Donor Site Wound(Patients will be monitored for 6 months post-operatively.)
研究者
Eitan Prisman
Clinical Associate Professor
University of British Columbia