Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction

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 wounds requiring reconstructive surgery to restore function and aesthetics. Older, frail patients are particularly vulnerable to complications from these invasive procedures often leaving them to care for chronic wounds until a split-thickness skin graft can be placed. Recombinant human platelet-derived growth factor (rhPDGF) is a manufactured protein that signals through the PDGF receptor, PDGFRβ, to mediate inflammation, granulation, angiogenesis, and remodeling during wound healing and skin repair and is FDA-cleared for diabetic neuropathic ulcers and periodontal bone and soft tissue reconstructions. Preclinical and clinical data suggest that rhPDGF may be a viable therapeutic strategy to augment the reconstruction of these complex surgical wounds by accelerating healing and reducing the time-to-readiness for skin graft placement.

Eligibility

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 the safety of the individual with study participation and/or the ability of the individual to follow study protocol
* The device will not fit the contour of the base of the wound bed
* Evidence of current clinical infection as demonstrated by the invasion of bacteria into the healthy viable tissue on the periphery of the wound (colonization of wound bed due to normal flora or environment is not exclusionary)
* Prior radiation therapy at the application site
* Known allergic reactions to porcine tissue, porcine collagen, or yeast-derived products
* Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in wound bed or may potentially interact with study treatment
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

Conditions4

Locations1 site

Browse More Trials