A Randomized, Double-Blinded, Controlled Trial Evaluating rhPDGF-BB-Enhanced Wound Matrix for Reconstruction of Full-Thickness Head or Neck Defects After Skin Cancer Excision

What this Trial Is About

Researchers are evaluating recombinant human platelet-derived growth factor B (rhPDGF-BB) enhanced wound matrix to improve healing in patients with full-thickness head or neck defects after skin cancer removal. The study focuses on wounds that cannot be closed with stitches or other simple methods and require complex reconstruction. This Phase II trial aims to compare rhPDGF-BB with a wound matrix saturated in normal saline to see if it can speed up granulation, re-epithelialization, wound closure, and improve pain and quality of life. Participants will be randomly assigned to receive either the rhPDGF-BB-enhanced wound matrix or a normal saline-saturated wound matrix in a double-blinded manner. The wound matrix is placed into the wound bed during a baseline procedure, and the randomization is stratified by location and wound size. Follow-up visits occur on day 6 for clinical examination and dressing changes, then at weeks 4 and 8 for further assessment and photographs. Daily wound photos will be taken at home using a special mobile app from day 7 to day 56. Participants will be closely monitored through clinical exams, photography, pain assessments, and quality of life surveys throughout the 8-week study period. Wound experts will review photos to measure the rate and extent of wound healing, including time to readiness for skin graft. Weekly tracking of adverse events and pain will be done using electronic health records, phone calls, or emails. The study starts upon informed consent and ends after the final follow-up visit.

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