About this trial
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 a higher incidence of chronic skin ulcers, skin grafts, and other skin and connective tissue disorders suggesting that the loss of PDGFβ signaling may impair healing following trauma. rhPDGF-BB, a recombinant human platelet derived growth factor protein-based therapy, signals through 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. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
RhPDGF-BB
Drug0.3 mg/mL rhPDGF-BB
Saline
DrugNormal saline
Treatment groups
Trial outcomes
Primary outcomes
Time-to-Readiness for Skin Graft in Days
Time to 81-100% granulation of wounds as assessed by expert clinical review of photographs taken daily starting at day 7
Secondary outcomes
Granulation Rate
Percent granulation versus time in days as determined by clinical assessment of the percent granulation of the wound bed in photographic images taken daily starting at day 7 following the baseline procedure.
Change in Granulation on a 5-Point Scale
Weekly ordinal scale outcomes of granulation as determined by clinical review of wound bed granulation in photographs taken daily starting at day 7 following the baseline procedure. Ordinal scale ranges from 1 to 5 in the increments below. * 0-20% granulation = 1 * 21-40% granulation = 2 * 41-60% granulation = 3 * 61-80% granulation = 4 * 81-100% = 5
Time to re-epithelialization
Time to 100% re-epithelialization as assessed by expert clinicians utilizing the NetHealth Tissue Analytics software to measure the percent of new epithelial tissue formed on the wound in daily photographs
Re-epithelialization rate
Percent re-epithelialization versus time as assessed by expert clinicians utilizing the NetHealth Tissue Analytics software to measure the percent of new epithelial tissue formed on the wound in daily photographs
Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
Lynch Regenerative Medicine
Collaborator