Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large defects requiring reconstructi
| Condition(s) | Wound Healing, Surgical Wound |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large defects requiring reconstruction to restore function and aesthetics. Rotational flaps and free flaps are techniques used to reconstruct large, complex defects that cannot be closed with sutures, staples, or glue. Older, frail patients are particularly vulnerable to complications from these procedures often leaving them to care for chronic wounds until a skin graft can be placed. Phenome-wide association studies (PheWAS) revealed a cohort of patients with a single nucleotide variant (SNV) in PDGFRβ having |
| Who can participate | Inclusion Criteria: * Underwent surgery to completely remove skin cancer, either Mohs micrographic or wide local excision, that left a full-thickness surgical defect of the head or neck measuring between 1.5-10cm in greatest dimension with clear margins as assessed in the pathology report. * Margins of the wound cannot be approximated or closed with stitches, sutures, staples, or glue * Surgeon does not plan for immediate skin graft or flap * Aged \>21 years old * Willing and able to provide informed consent for study participation and compliance with study protocol * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Medical conditions that would, in the opinion of the Investigator or treating provider, compromise th |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Vanderbilt University Medical Center |
| Locations | Nashville, Tennessee, United States |
| Start date | 2025-04-01 |
| NCT ID | NCT06634030 |
| Official listing | https://clinicaltrials.gov/study/NCT06634030 |