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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called rhPDGF-BB, which is designed to help improve healing for patients who have undergone surgery to remove skin cancers from the head and neck. After such surgeries, patients may be left with large wounds that require additional procedures to heal properly. The goal of this trial is to see if using rhPDGF-BB can speed up the healing process and prepare the wound for a skin graft more quickly, especially for older patients who may face more complications.

To participate in this trial, individuals must be over 21 years old and have had surgery to remove skin cancer, leaving a significant wound that cannot be stitched closed. Participants should be willing to follow the study guidelines and be available for the duration of the trial. Those who have certain medical conditions, current infections, or known allergies to specific materials will not be eligible. The trial has not yet started recruiting participants, but if you or someone you know is interested, it could provide an opportunity to help improve healing for complex wounds.

Gender

ALL

Eligibility criteria

• 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