Both SynePure and Catasyn are wound care medical devices that have secured 510(k) clearance from the FDA
Synedgen has commenced the randomised controlled trial (RCT) to evaluate the safety and efficacy of SynePure wound cleanser in combination with Catasyn advanced technology hydrogel to treat superficial partial-thickness burn wounds.
The investigator-initiated randomised trial will compare SynePure and Catasyn (intervention group) to the current gold standard treatment Silvadene (control group).
According to the company, the two groups will receive the same care other than cleansing treatment.
Dr Peter Rubin is the principal investigator for the study, which will recruit the patients from the University of Pittsburgh Medical Centre (UPMC) Mercy Burn Centre. Rubin is the chair of plastic surgery at UPMC.
The subjects will consist of the adult patient population who have sustained superficial partial- thickness burn wounds.
Synedgen secured funding for the trail from the Defense Health Agency (DHA) through the US Army Medical Research and Development Command’s (USAMRDC) Small Business Innovation Research (SBIR) programme.
Synedgen president and CEO Dr Shenda Baker said: “We believe the combination of our two wound care products is not only safe but improves time-to-heal and infection rates in superficial partial-thickness burn wounds versus the current standard of care treatment.
“We are thankful to our partners at the DHA and USAMRDC for funding this important study, which we hope will introduce an improved standard of care for partial thickness burns.”
Both SynePure and Catasyn are wound care medical devices, which have secured 510(k) clearance from the US Food and Drug Administration (FDA).
The products are suitable for the treatment of initial trauma within the acute care gap of the minutes or hours immediately following traumatic injury.
Both devices are formulated with a novel glycopolymer, which are biocompatible and protective of dermal surfaces.
SynePure is optimised for the cleansing and debridement of wounds and thermal injuries, while Catasyn is a protective gel dressing that offers an environment to support wound healing.
The biocompatible SynePure and Catasyn are shelf-stable up to two years and non-staining.