RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-Blinded, Controlled Trial Evaluating Recombinant Human Platelet-Derived Growth Factor B (rhPDGF-BB)-Enhanced Wound Matrix in the Reconstruction of Full-Thickness Head or Neck Defects Following Skin Cancer Excision

Quick Facts

Study Start:2025-04-01
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06634030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Margins of the wound cannot be approximated or closed with stitches, sutures, staples, or glue
  3. * Surgeon does not plan for immediate skin graft or flap
  4. * Aged \>21 years old
  5. * Willing and able to provide informed consent for study participation and compliance with study protocol
  6. * Stated willingness to comply with all study procedures and availability for the duration of the study
  1. * 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
  2. * The device will not fit the contour of the base of the wound bed
  3. * 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)
  4. * Prior radiation therapy at the application site
  5. * Known allergic reactions to porcine tissue, porcine collagen, or yeast-derived products
  6. * 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
  7. * Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

Contacts and Locations

Study Contact

Jacob J Smith
CONTACT
615-875-7466
jacob.smith@vumc.org
Cyndi R Clark, PhD
CONTACT
cyndi.r.clark@vumc.org

Principal Investigator

Wesley P Thayer
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Wesley P Thayer, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Complex Surgical Defect
  • Skin Cancer Excision
  • Platelet-Derived Growth Factor
  • Skin Graft

Additional Relevant MeSH Terms

  • Wound Healing
  • Surgical Wound
  • Graft Failure