Comparative Effectiveness of Clostridial Collagenase Ointment to Medicinal Honey for Treatment of Venous Leg Ulcers in the Hospital Outpatient Department Setting

Objective: The objective of this study was to assess the clinical effectiveness of enzymatic debridement with clostridial collagenase ointment (CCO) relative to autolytic debridement with medicinal honey (MH) in the hospital outpatient department (HOPD) setting for the treatment of VLU.

Methods: Retrospective de-identified electronic medical records from 2007-2013 were extracted from the U.S. Wound Registry (USWR). The USWR is a longitudinal observation database of chronic wounds from more than 100 HOPD wound centers in the U.S. A propensity score matching method was used to adjust for selection bias and to test for treatment effects between wounds treated with CCO versus MH.

Results: A total of 9,313 patients, 22,312 wounds, and 186,023 visits for VLU were identified. The majority of patients were female (51.9%) with an average age of 61.6 (SD=17.7). Approximately 21.3% had a history of hypertension, 8.3% had a history of venous insufficiency with diabetes. Mean baseline wound surface area was 7.9cm² (SD=14.4). The average wound age at baseline was 8.5 months (SD=27.8) and average treatment duration was 2.9 months (SD=4.9). Of the 22,312 VLU, approximately 13.2% received CCO (n=2,954) and 2.2% received medicinal honey (n=495). VLU treated with medicinal honey were significantly more likely (p<0.0001) to be active and chronic after 60 days relative to wounds treated with CCO (13% versus 9%, respectively). Furthermore, VLU treated with CCO were significantly more likely (p<0.01) to achieve 100% granulation by the end of therapy compared to wounds treated with medicinal honey (30% versus 19%, respectively). Finally, VLU treated with CCO were significantly more likely (p<0.0001) to close by the end of therapy relative to wounds treated with MH (45% versus 31%, respectively).

Conclusion: Over the course of therapy VLU treated with CCO demonstrate greater clinical improvement with respect to granulation and closure than VLU treated with MH.