Using a special wound matrix to improve healing after skin cancer surgery on the head and neck
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
This study is testing a special treatment to see if it can help people heal better after having skin cancer surgery on their head and neck.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06634030 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the effectiveness of a recombinant human platelet-derived growth factor (rhPDGF-BB) enhanced wound matrix compared to a saline-saturated matrix for reconstructing surgical defects on the head and neck after skin cancer excision. Participants will be randomly assigned to receive either the rhPDGF-BB treatment or the control, and their healing progress will be monitored over eight weeks through clinical examinations and assessments of granulation rates, skin graft success, and quality of life. The study aims to provide insights into how this treatment can improve wound healing and aesthetic outcomes for patients with complex surgical defects.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 who have undergone surgery for skin cancer, resulting in a non-approximable full-thickness defect on the head or neck.
Not a fit: Patients with medical conditions that compromise their safety or ability to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance wound healing and reduce complications for patients undergoing reconstructive surgery after skin cancer removal.
How similar studies have performed: Previous studies have shown promising results with similar approaches using rhPDGF in wound healing, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Wesley P Thayer — Vanderbilt University Medical Center
- Study coordinator: Jacob J Smith
- Email: jacob.smith@vumc.org
- Phone: 615-875-7466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.