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NPWT resource use compared with standard moist wound care in diabetic foot wounds: DiaFu randomized clinical trial
Dörthe Seidel1, Rolf Lefering2,
1Institut für Forschung in der Operativen Medizin (IFOM), University of Witten/Herdecke, Ostmerheimerstraße 200 Haus 38, 51109, Köln, Germany. DoertheSeidel@gmx.de.
Background:
Diabetic foot ulcers not only have a negative impact on patient mortality, morbidity and quality of life, but also require high resource utilization to achieve complete wound healing. The aim of this evaluation was to compare resource utilization of negative pressure wound therapy (NPWT) and standard moist wound care (SMWC) for diabetic foot wounds after amputation, surgical debridement or wound cleansing.
Methods:
The multicenter clinical DiaFu study enrolled 368 adults with diabetic foot ulcers between December 23, 2011 and October 21, 2014. Patients were randomly assigned to NPWT and SMWC. Evaluation of direct resource use comprised inpatient and outpatient treatment time, and personnel and material for wound treatment within 16 weeks. This resource use analysis was primarily based on the per protocol population (NPWT 44; SMWC 110).
Results:
Treatment duration was 16 days shorter with NPWT (mean (SD) 82.8 (31.6), SMWC 98.8 (24.6); U test, p = 0.001) with 14.9 days shorter outpatient treatment (mean (SD) NPWT 68.3 (31.1), SMWC 83.2 (29.7)). The number of dressing changes per study participant was lower with NPWT (mean (SD) 35.1 (18.6), SMWC (42.9 (21.4); U test, p = 0.067). Time per dressing change was significantly lower with SMWC (mean (SD) 19.7 (12.8), NPWT (16.5 (8.2) minutes; U test, p < < 0.0001). Time for surgical debridements per study participant was 23.3 minutes shorter with NPWT (mean (SD) 20.5 (20.5), SMWC (43.8 (46.7); U test, p = 0.395).
Conclusions:
Resource use was lower for NPWT, which may be an efficient treatment alternative to SMWC for diabetic foot wounds, to be demonstrated in subsequent cost analyses.
Trial Registration:
clinicaltrials.gov NCT01480362 on November 28, 2011.
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