Increased Healing Rates of Venous Leg Ulcers Treated with Native Type I Collagen Matrix plus Polyhexamethylene biguanide (PHMB) Antimicrobial in Addition to Standard Practices: Interim Results from the RESPOND Registry
George J. Koullias, MD.
SUNY Stony Brook University Hospital, Stony Brook NY, NY, USA.
OBJECTIVES: Bacterial bioburden and biofilm in the wound can result in elevated protease activity and extracellular matrix degradation, which have been associated with prolonging the inflammatory phase in venous leg ulcers (VLUs). (Purified) native type 1 collagen matrix, in combination with polyhexamethylene biguanide (PHMB) antimicrobial (PCMP), is believed to manage bacterial bioburden and prevent biofilm reformation. The aim of this abstract is to present an analysis of the effect of PCMP on the management of VLUs in subjects from a prospective registry of patients treated with PCMP on a variety of wounds
METHODS: The RESPOND Registry is a prospective registry of 300 patients from 30 centers in the US. Patients, with a variety of wound types, are treated with PCMP in addition to standard wound care practices and are followed for 24 weeks. Interim analysis of data from the first 18 VLU patients who participated in the registry was performed. All patients received noninvasive venous studies and appropriate endovenous interventions in addition to compression, venous ulcer debridements, and weekly PCMP applications on the ulcer as indicated.
RESULTS: A total of 18 patients with 18 VLUs (mean age 79.2, 67% Female, BMI 26.7, mean ulcer area 14.95 cm2, mean duration 3.92 months prior to study enrollment) were treated. By week 4, a total of 7 VLUs (38.8%) healed and 11 showed greater than 40% reduction in wound area. By week 8, a total of 12 VLUs (66.6%) showed greater than 80% reduction in wound area. By week 12, 11 VLUs (61.1%) healed completely. Of the remaining 7 VLUs that did not close by week 12, 4 were significantly reduced in size; so, by week 12, 15 VLUs (83.3%) either healed or improved.
CONCLUSIONS: PCMP with appropriate adjunct local care, compression and endovenous interventions showed improved VLU healing rates. The success of this VLU management strategy demonstrates the importance of managing bioburden and preventing biofilm reformation. This, in addition to the significance of applying an integrated strategy involving endovenous interventions and standard VLU practices, can improve VLU healing outcomes and reduce related complications
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