Przemyslaw Rys1, Sebastian Borys2,3, Jerzy Hohendorff2,3, Aleksandra Zapala1, Przemyslaw Witek2,3, Magdalena Monica1, Claudia Frankfurter4, Agnieszka Ludwig-Slomczynska5, Beata Kiec-Wilk2,3, Maciej T Malecki6,7. 1. HTA Consulting, Krakow, Poland. 2. Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland. 3. Department of Metabolic Diseases, University Hospital in Krakow, Krakow, Poland. 4. Faculty of Medicine, University of Toronto, Toronto, ON, Canada. 5. Center for Medical Genomics OMICRON, Jagiellonian University Medical College, Krakow, Poland. 6. Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland. maciej.malecki@uj.edu.pl. 7. Department of Metabolic Diseases, University Hospital in Krakow, Krakow, Poland. maciej.malecki@uj.edu.pl.
Abstract
PURPOSE: Negative-pressure wound therapy (NPWT) is an adjunct modality in diabetic foot ulcerations (DFUs). Randomized controlled trials (RCTs) have shown its advantage over standard approaches; however, data from observational studies remain scarce.We performed a systematic review of observational non-RCTs evaluating NPWT efficacy and safety in patients with DFU. METHODS: Electronic databases were searched for observational studies involving NPWT. The results of single-arm studies were presented as percentages of patients with the outcome of interest. A meta-analysis of comparative studies provided point estimates of outcomes. Continuous outcomes were reported as either weighted or standardized mean differences and dichotomous data as relative risks (RR). RESULTS: The search identified 16 relevant observational studies, 12 single-arm, and 4 comparative, reporting on a total of 18,449 patients with DFU, of whom 1882 were managed with NPWT. In the NPWT-treated patients, ulcers were larger (average size range 6.6-27.9 cm2), as compared with controls (≤3 cm2). The pooled results showed healing and major amputation in 51% and 5% of NPWT patients, respectively. The meta-analysis of comparative studies revealed lower risk of major amputation [RR = 0.23 (0.07; 0.80)] in NPWT-treated patients. The pooled results for healing rate and risk of any amputation were inconclusive due to large between-study heterogeneity. Overall, 6 deaths out of 158 patients were reported, none of them related to NPWT. Serious adverse events occurred in 6% of patients on NPWT. CONCLUSIONS: This systematic review of observational studies provided supportive evidence that NWPT is an efficient and safe adjunct treatment in the management of DFUs.
PURPOSE: Negative-pressure wound therapy (NPWT) is an adjunct modality in diabetic foot ulcerations (DFUs). Randomized controlled trials (RCTs) have shown its advantage over standard approaches; however, data from observational studies remain scarce.We performed a systematic review of observational non-RCTs evaluating NPWT efficacy and safety in patients with DFU. METHODS: Electronic databases were searched for observational studies involving NPWT. The results of single-arm studies were presented as percentages of patients with the outcome of interest. A meta-analysis of comparative studies provided point estimates of outcomes. Continuous outcomes were reported as either weighted or standardized mean differences and dichotomous data as relative risks (RR). RESULTS: The search identified 16 relevant observational studies, 12 single-arm, and 4 comparative, reporting on a total of 18,449 patients with DFU, of whom 1882 were managed with NPWT. In the NPWT-treated patients, ulcers were larger (average size range 6.6-27.9 cm2), as compared with controls (≤3 cm2). The pooled results showed healing and major amputation in 51% and 5% of NPWT patients, respectively. The meta-analysis of comparative studies revealed lower risk of major amputation [RR = 0.23 (0.07; 0.80)] in NPWT-treated patients. The pooled results for healing rate and risk of any amputation were inconclusive due to large between-study heterogeneity. Overall, 6 deaths out of 158 patients were reported, none of them related to NPWT. Serious adverse events occurred in 6% of patients on NPWT. CONCLUSIONS: This systematic review of observational studies provided supportive evidence that NWPT is an efficient and safe adjunct treatment in the management of DFUs.