Organogenesis said today that it launched its PuraPly Antimicrobial clinical research program, which will evaluate patients treated with PuraPly AM for up to 12 weeks. The 1st studies have started enrolling patients, according to Organogenesis.
The Canton, Mass.-based company’s PuraPly AM is a 510(k)-cleared device indicated for the management of acute and chronic wounds. The device is made of a bi-layered purified Type I collagen sheet, loaded with a broad spectrum antimicrobial agent that acts as a barrier against microbial colonization within wound dressings.
The NY-based studies will evaluate the device as an antimicrobial wound management therapy, as well as its ability to manage bioburden, support granulation tissue formation and support wound closure, Organogenesis reported.
“Up until now, we’ve seen encouraging case studies showing individual patient results following treatment with PuraPly AM,” co-principal investigator Dr. Harold Brem said in prepared remarks. “While those studies have yielded valuable information, the completion of this 100 patient prospective research program will provide wound care clinicians with important clinical data regarding how PuraPly AM is utilized in various wound types and the associated clinical outcomes.”
“We are very excited to be at the forefront of this important research initiative to further our understanding of this unique product,” co-principal investigator Dr. Alisha Oropallo added. “With biofilm being implicated in the majority of chronic wounds, a product like PuraPly AM holds great promise and we look forward to generating data to assess the clinical benefit.”
The company also said it launched a nationwide patient registry that is slated enroll 300 patients. Organogenesis plans to use the Respond registry to assess the use of its PuraPly AM device in real-world clinical settings.
The company said it will evaluate the effectiveness of the its device according to percent reduction in wound size, time to wound closure and improvements in wound bed condition. Researchers will follow up with the patients enrolled in the registry for up to 24 weeks, Organogenesis said.
The registry will also gather patient-reported data about pain and quality of life measures, including economic outcome information.
“Organogenesis is committed to developing and manufacturing innovative products backed by sound clinical research and scientific data, that serve our customers’ needs,” president & CEO Gary Gillheeney, Sr., said. “We look forward to sharing the valuable findings of both the PuraPly Antimicrobial clinical research program and the Respond registry with the entire wound care community.”