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Clinical Research
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Equating the clinician's intention with a successful wound care outcomeÑresults from a randomized controlled trial comparing vacuum assisted closure* to standard therapy (ST) in the treatment of diabetic foot amputation wounds Wyatt Payne, MD, FACS. Bay Pines VA Medical Center, Bay Pines, FL; Michael S. Keith, PhD, PharmD, KCI USA, San Antonio, TX PURPOSE:.Diabetic foot amputation wounds can prove difficult to heal. The presence of comorbidities increases the risk of delayed healing. Non-surgical closure, occurring through the natural process of granulation, contraction, and epithialization, should be allowed to continue as long as the wound is healing at a rate commensurate with the clinicianÕs expectation. METHODOLOGY:.In this 16-week multi-center, randomized trial, data were analyzed based on categorization of original treatment intention. Following categorization by original treatment intention, the likelihood of achieving complete wound closure was evaluated using a 2-tailed FisherÕs Exact Test for comparing two independent binomial proportions. Relative risk was also evaluated and was described as the risk of complete wound closure (100%) in the NPWT (V.A.C.¨ Therapy) patient population versus the ST population (alginates, foam, hydrogel, hydrocolloids). RESULTS:.Non-surgical closure was the most common original treatment intention regardless of treatment group. On average, non-surgical closure was the original therapy intention of clinicians in 53.7% of patients enrolled in the present trial (NPWT: 53.3%, ST: 54.1%). .For subjects with non-surgical intervention as the intended treatment course, complete wound closure (100%) was achieved in 61.0% of patients randomized to receive NPWT compared to 37.0% of patients randomized to receive ST (P=0.032). Moreover, clinicians were 1.62 times more likely to achieve complete closure in patients originally identified for non-surgical closure, if they used NPWT when compared to ST (95% CI: 1.03 - 2.51).. .CONCLUSION:.The findings from this study indicate that, after evaluation and determination of the most appropriate treatment algorithm, clinicians have a higher likelihood of achieving success with the pre-planned treatment intention when using NPWT compared to ST. The clinical and economic implications of not achieving planned treatment intentions in wound closure should be further evaluated Study was funded by KCI, USA *V.A.C.¨ KCI USA, San Antonio, TX |
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