RecruitingPhase 2NCT06634030

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

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


Sponsor

Vanderbilt University Medical Center

Enrollment

40 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wound-healing product containing a growth factor (rhPDGF-BB) for repairing skin wounds on the head and neck after skin cancer removal surgery (Mohs surgery or wide excision). After removing skin cancer, some wounds are too large to close with stitches and need an alternative. This product is designed to stimulate healing in those difficult-to-close wounds. **You may be eligible if...** - You are over 21 years old - You had surgery to completely remove skin cancer from the head or neck - The wound is between 1.5 and 10 cm and could not be closed with stitches or sutures - The surgeon is not planning an immediate skin graft or flap procedure - You are willing and able to follow the study protocol for the full duration **You may NOT be eligible if...** - You have a medical condition that would make participation unsafe - There is an active infection in the wound tissue - The wound site previously received radiation therapy - You have an allergy to porcine (pig) tissue, porcine collagen, or yeast-derived products - You are pregnant, breastfeeding, or planning to become pregnant during the trial - You are currently in another drug or device trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRhPDGF-BB

0.3 mg/mL rhPDGF-BB

DRUGSaline

Normal saline


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06634030


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