| 9 |
Clinical Research
|
Time to 50% reduction in wound area as a significant predictor of complete wound closure in patients with partial diabetic foot amputationsÑresults from a randomized controlled trial comparing vacuum assisted closure* to standard therapy (ST) Jose Ayala, DPM, Valley Baptist Medical Center, Wound Center, Brownsville, TX; Wyatt Payne, MD, FACS, Bay Pines VA Medical Center, Bay Pines, FL; Michael S. Keith, PhD, PharmD, KCI USA, San Antonio, TX PURPOSE: .Foot wounds are one of the most common sequelae of diabetes mellitus. The value of wound area reduction relative to outcome continues to be of major interest. The prognostic value of this measurement was an objective in this study to quantify the relationship between wound area reduction and complete wound closure between patients treated with two different modalities. .METHODOLOGY: .In this 16-week multicenter, randomized controlled trial, data were analyzed using a time-to-event strategy with Kaplan-Meier estimates. Median time to 50% and complete wound closure were also calculated and compared. Relative risk was assessed with a logistic regression model. .RESULTS:.Seventy-seven percent (77%) of the 162 randomized patients achieved a 50% reduction in wound area; however, less than half of the ST patients later achieved full closure, compared to approximately three-quarters of the NPWT (V.A.C.¨ Therapy) patients. The proportion of patients who achieved a 50% reduction in wound area was similar between groups; however the event-time distribution function favored NPWT patients. Median time to 50% wound closure for the NPWT group was 29 days (95% CI 28,41) and 42 days for the ST group (95% CI 29, 46). Once a 50% reduction in wound area was observed, NPWT patients. were 1.49 times more likely to achieve complete wound closure than ST patients (P=0.011, 95% CI: 1.12, 2.00). .CONCLUSION:.Time to 50% wound area reduction is a meaningful predictor of outcome in interventional treatments. In this trial, the strength of the relationship between wound area reduction and complete wound closure observed in NPWT patients appears to be a function of the healing trajectory. In this study of diabetic foot amputation patients, NPWT was associated with a shorter time to achieve 50% reduction in wound area and a greater likelihood of subsequent complete wound closure This project was funded by KCI, USA..*V.A.C.¨ KCI USA, San Antonio, TX |
|