Lynch Regenerative Medicine has completed participant enrolment in a Phase II clinical trial assessing the recombinant human pure platelet-derived growth factor-BB (rhPDGF-BB) as an adjunctive therapy for surgical wounds following skin cancer excision.
The randomised, double-blind, controlled study is sponsored by Vanderbilt Health and funded by Lynch Regenerative Medicine.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It is assessing whether rhPDGF-BB can promote faster healing in full-thickness head and neck defects. These types of wounds can occur after procedures such as Mohs micrographic surgery or wide local excision.
They are often complex and may not be suitable for immediate closure using sutures, staples or glue, particularly in older or medically vulnerable patients.
The trial has enrolled 34 patients in total, nine presenting with full-thickness scalp wounds and 25 with wounds on the face or neck following skin cancer excision.
It compares the effects of an rhPDGF-BB-enhanced collagen wound matrix against the standard of care, which in this study is a saline-treated collagen wound matrix.
Assessment measures include time to and rate of granulation tissue formation, overall healing rate, time to and rate of wound closure, scar appearance, aesthetics, pain levels and quality of life.
Blinded expert review, standardised wound imaging, and quantitative digital analysis are being used to evaluate the data over the trial’s eight-week follow-up period.
Lynch Regenerative Medicine founder and CEO Dr Samuel Lynch said: “For patients with complex wounds following skin cancer excision, the time it takes to become ready for reconstruction is a debilitating part of the recovery process.
“This study is asking an important clinical question: can pure PDGF accelerate healing of large head and neck surgical wounds and help move patients toward wound closure sooner and with less scarring? With enrolment complete, we are one step closer to understanding the potential of pure PDGF to enhance patient outcomes in this challenging setting.”
According to the company, the rhPDGF-BB use in this trial remains investigational and has not received the US Food and Drug Administration approval for this indication.
Enrolled patients will be followed during an eight-week assessment period before data analysis is initiated.
