The safety of negative pressure wound therapy using vacuum‐assisted closure in diabetic foot ulcers treated in the outpatient setting

Abstract

The purpose of this project was to evaluate the safety of negative pressure wound therapy using the vacuum-assisted closure (V.A.C.) Therapy System (KCI, San Antonio, TX) in diabetic foot ulcers (DFUs) among wound centre outpatients. We defined events that could represent complications or adverse events (AEs) as a result of treatment with the V.A.C., including symptoms of infection, pain, bleeding and periwound skin breakdown. The frequency of these AEs among V.A.C. patients with DFUs was compared with those among similar non V.A.C. patients. This project prospectively queried data collected during routine clinical care from 16 outpatient wound centres using the Intellicure electronic medical record system. The electronic records were de-identified according to HIPAA requirements and pooled to create a data repository dedicated to research (the Intellicure Research Consortium). Analysis was performed on 1331 DFUs representing 16,438 outpatient visits. A total of 1299 non V.A.C. and 72 V.A.C. DFUs were available for analysis. There was either no statistical difference between the AEs of V.A.C. versus non V.A.C. patients or the V.A.C. exerted a protective effect. We conclude that the V.A.C. is safe in outpatient use.

Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: Steps towards an international consensus

“…[30e32], L2: [33], L4: [34]), cost of treatment (L1: [35], L2-: [36], L2: [33,37], L4: [34]), speed of granulation tissue formation (L1: [30e32,38]), lower amputation rates (L1: [30,31], L2: [39], L4: [34]), faster decrease in wound dimensions (L1: [31,32,40]) have all been reported with no detrimental effects on the rate of complications or adverse events (L1: [30,31], L2: [41]). …”

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records

“…A more valid question is whether the clinician, in fact, made the correct diagnosis. One experienced physician preceptor remotely viewed the initial consultations of 952 patients in the USWR, including more than 2,000 associated digital wound photographs, to evaluate the accuracy of the diagnoses assigned by 4 different physician users participating in a remote medical quality management pilot project . Approximately 18% of the wound diagnoses were questioned by the preceptor on the basis of photographs, including possible misclassification of ulcer type (e.g., arterial ulcer misclassified as a venous ulcer), or a missed wound diagnosis, none of which could be confirmed by photographic assessment alone (e.g., possible pyoderma gangrenosum, vasculitis, and skin cancer).…”

“…Although these real‐world patients would likely be excluded from any wound care RCT, both safety and CER with such complex patients are not only possible but also necessary. For example, patients taking anticoagulants were excluded from all negative pressure wound therapy (NPWT) RCTs (Table ) . When the FDA questioned the safety of NPWT in the home setting among patients taking anticoagulants, USWR data were used to demonstrate the safety of NPWT among 200 patients on Coumadin.…”

“…One experienced physician preceptor remotely viewed the initial consultations of 952 patients in the USWR, including more than 2,000 associated digital wound photographs, to evaluate the accuracy of the diagnoses assigned by 4 different physician users participating in a remote medical quality management pilot project. 35 Approximately 18% of the wound diagnoses were questioned by the preceptor on the basis of photographs, including possible misclassification of ulcer type (e.g., arterial ulcer misclassified as a venous ulcer), or a missed wound diagnosis, none of which could be confirmed by photographic assessment alone (e.g., possible pyoderma gangrenosum, vasculitis, and skin cancer). Thus, although this unique electronic system simplifies the process of identifying a very precise wound diagnosis code, it does not prevent errors in diagnosis, which may continue to occur at a predicable rate, even among physicians who underwent precepting for more than a year.…”

“…For example, patients taking anticoagulants were excluded from all negative pressure wound therapy (NPWT) RCTs ( Table 2). 35 When the FDA questioned the safety of NPWT in the home setting among patients taking anticoagulants, USWR data were used to demonstrate the safety of NPWT among 200 patients on Coumadin. USWR data were necessary to assess NPWT safety due to the a priori exclusion criteria of the RCT.…”