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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06031337 -
Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
|
||
Completed |
NCT00158678 -
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
|
Phase 3 | |
Completed |
NCT00933387 -
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
|
Phase 2 | |
Enrolling by invitation |
NCT05030597 -
Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
|
N/A | |
Completed |
NCT03682562 -
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
|
||
Recruiting |
NCT03684707 -
Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
|
Phase 4 | |
Recruiting |
NCT06130332 -
Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)
|
Phase 2 | |
Recruiting |
NCT04372914 -
Prevention of Oral DNA Damage by Black Raspberries
|
N/A | |
Active, not recruiting |
NCT03529422 -
Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN
|
Phase 2 | |
Recruiting |
NCT03686020 -
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
|
||
Not yet recruiting |
NCT06060288 -
Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
|
||
Withdrawn |
NCT00951470 -
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT00964977 -
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
|
Phase 3 | |
Completed |
NCT01418118 -
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery
|
Phase 4 | |
Active, not recruiting |
NCT00232960 -
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC
|
N/A | |
Recruiting |
NCT05429099 -
Mandibular Reconstruction Preplanning (ViPMR)
|
Phase 2/Phase 3 | |
Completed |
NCT04614896 -
Use of Ultrasound for Measuring Size of Oral Tongue Cancers
|
N/A | |
Recruiting |
NCT03685409 -
Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions
|
Phase 3 | |
Completed |
NCT00402779 -
Erlotinib Prevention of Oral Cancer (EPOC)
|
Phase 3 | |
Recruiting |
NCT05153733 -
Improved Implant for Reconstruction Purposes After Mandibular Resection
|
N/A |