title: 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.
authors.affiliation: Department of Anesthesiology, The University of Texas Health Science Center, Houston, TX 77030, USA. caroline.e.fife@uth.tmc.edu
authors.forename: Caroline E
authors.initials: CE
authors.lastname: Fife
authors.forename: David
authors.initials: D
authors.lastname: Walker
authors.forename: Brett
authors.initials: B
authors.lastname: Thomson
authors.forename: Gordon
authors.initials: G
authors.lastname: Otto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care / Q000379:methods*; D000704:Analysis of Variance; D002908:Chronic Disease; D015897:Comorbidity; D003428:Cross Infection / Q000209:etiology; D017719:Diabetic Foot / Q000453:epidemiology / Q000209:etiology / Q000628:therapy*; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D016014:Linear Models; D016347:Medical Records Systems, Computerized; D008875:Middle Aged; D054843:Negative-Pressure Wound Therapy / Q000009:adverse effects / Q000379:methods*; D010146:Pain / Q000209:etiology; D011446:Prospective Studies; D012307:Risk Factors; D012449:Safety; D012720:Severity of Illness Index; D012907:Smoking / Q000009:adverse effects; D013781:Texas / Q000453:epidemiology; D016896:Treatment Outcome; D014945:Wound Healing