Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
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 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 PDGFR having a higher incidence of chronic skin ulcers, skin grafts, and other skin and connective tissue disorders suggesting that the loss of PDGF signaling may impair healing following trauma. rhPDGF-BB, a recombinant human platelet derived growth factor protein-based therapy, signals through PDGFR 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. These data suggest rhPDGF-BB may be a viable therapeutic strategy to augment the reconstruction of these complex defects by accelerating granulation, epithelialization, and wound closure.
Head/Neck
Phase II
Adults
Not Available
Not Available
Thayer, Wesley
Local
Vanderbilt University
04-01-2025
Eligibility
22 Years and older
ALL
false
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
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
