PMID- 18577134 OWN - NLM STAT- MEDLINE DCOM- 20081003 LR - 20211020 IS - 1742-481X (Electronic) IS - 1742-4801 (Print) IS - 1742-4801 (Linking) VI - 5 Suppl 2 IP - Suppl 2 DP - 2008 Jun TI - The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. PG - 17-22 LID - 10.1111/j.1742-481X.2008.00467.x [doi] AB - 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. FAU - Fife, Caroline E AU - Fife CE AD - Department of Anesthesiology, The University of Texas Health Science Center, Houston, TX 77030, USA. caroline.e.fife@uth.tmc.edu FAU - Walker, David AU - Walker D FAU - Thomson, Brett AU - Thomson B FAU - Otto, Gordon AU - Otto G LA - eng PT - Journal Article PL - England TA - Int Wound J JT - International wound journal JID - 101230907 SB - IM MH - Aged MH - Aged, 80 and over MH - Ambulatory Care/*methods MH - Analysis of Variance MH - Chronic Disease MH - Comorbidity MH - Cross Infection/etiology MH - Diabetic Foot/epidemiology/etiology/*therapy MH - Hemorrhage/etiology MH - Humans MH - Linear Models MH - Medical Records Systems, Computerized MH - Middle Aged MH - Negative-Pressure Wound Therapy/adverse effects/*methods MH - Pain/etiology MH - Prospective Studies MH - Risk Factors MH - *Safety MH - Severity of Illness Index MH - Smoking/adverse effects MH - Texas/epidemiology MH - Treatment Outcome MH - *Wound Healing PMC - PMC7951348 COIS- This project was funded by KCI. Both Caroline Fife and David Walker hold stock in Intellicure and are major shareholders in Intellicure. Brett Thomson is a minor shareholder in Intellicure. Gordon Otto has declare no conflicts of interest. EDAT- 2008/07/17 09:00 MHDA- 2008/10/04 09:00 PMCR- 2008/06/10 CRDT- 2008/07/17 09:00 PHST- 2008/07/17 09:00 [pubmed] PHST- 2008/10/04 09:00 [medline] PHST- 2008/07/17 09:00 [entrez] PHST- 2008/06/10 00:00 [pmc-release] AID - IWJ467 [pii] AID - 10.1111/j.1742-481X.2008.00467.x [doi] PST - ppublish SO - Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.