Alliqua BioMedical, announces a poster at SAWC meeting on Alliqua's Biovance Human Amniotic Membrane Allograft for wound care

Alliqua BioMedical announced that a poster on their Biovance Human Amniotic Membrane Allograft will be featured at the 2015 Symposium on Advanced Wound Care (SAWC), to be held in Las Vegas on 26–28 September. The poster, titled "Key Factors Influencing Outcomes of Dehydrated, Decellularized Human Amniotic Membrane Allograft (DDHAM) Treated Venous Ulcers in a Real World Experience Study," summarises the results of an observational study demonstrating the clinical benefit of using DDHAM (Biovance) in addition to compression therapy for the treatment of patients with venous stasis ulcers (VSUs). The results featured in this poster came from a registry study conducted across 19 centres in the United States that included 230 patients with 246 acute and chronic wounds.

The study was designed to explore the risk/benefit of using a decellularised, dehydrated, human amniotic membrane (DDHAM) allograft as part of the treatment regimen of any skin ulcer that investigators thought would benefit. The study enrolment inclusion criteria were broad (any non-infected wound), with the only exclusion criterion being known hypersensitivity to DDHAM. Ulcers of venous stasis etiology comprised the largest subset within the chronic wound group with 85 wounds in 78 intent-to-treat (ITT) subjects. The Good Wound Care (GWC) Group represents a subset of the ITT population. Good Wound Care was described as compliance with the use of compression dressings/wraps, maintenance of the applied allograft, no active infection at time of DDHAM initial placement, and no concomitant use of enzymatic debriders.

This observational study demonstrated clinical benefits in a real world, heterogeneous VSU population showing the following:

• 53% of the subjects in the GWC Group completely closed in an average observation period of about 6 weeks.
• The impact of good wound care, as defined in this study, resulted in a 26% increase in the incidence of closure for the GWC Group, compared to the ITT population.
• At an average of 8 weeks, the GWC Group's venous stasis ulcers reduced in size by nearly 68%.
• None of the venous stasis ulcers in the GWC Group that completely closed had reported infection prior to or during treatment while about one-third of those that did not close reported at least one episode of clinically suspected wound infection.

This observational study did not have a control arm. However, published venous leg ulcer studies demonstrate that under a controlled design, with restricted inclusion and exclusion criteria, an incidence of complete closure of 13–29% in 4 weeks to 6 months and a wound size reduction of 21–46% in the control arms over 4 to 12 weeks of treatment could be expected.