Comparison of Single Use and Traditional Negative Pressure Wound Therapy Devices in Lower Extremity Ulcers: A US Real-World Evidence Analysis of NetHealth Data.

Annually, 49 million people worldwide are impacted by lower extremity ulcers (LEUs). Diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) are the most common LEUs. Negative pressure wound therapy (NPWT) has emerged as an effective intervention for complex wounds, offering numerous favourable wound healing outcomes. The objective of this study was to evaluate the effectiveness of single-use NPWT (sNPWT) versus traditional NPWT (tNPWT) for wound closure in LEUs. Real-world data was obtained from the US-based Net Health outpatient database between January 2014 and October 2020 and included patients with LEUs (DFU or VLU) who had been treated with sNPWT or tNPWT. The rate of wound closure and time to wound closure were selected as endpoints. The wound closure rate was significantly higher for all LEUs (p = 0.039), VLUs alone (p = 0.003) and there was no difference for DFU (p = 0.90) that were treated with sNPWT versus tNPWT. The median time to wound closure was significantly shorter for sNPWT (114 days) compared to tNPWT (140 days, p < 0.01). Using sNPWT was associated with significantly higher wound closure rates and shorter time to wound closure. The results provide supportive evidence for using sNPWT for LEUs, demonstrating the opportunity to directly decrease the clinical burden of LEUs on patients. Subgroup analysis revealed a significant difference in wound closure rates for VLU, while no significant difference was observed for DFU. The overall LEU findings may be attributed to differences in the mechanisms of action between the two devices.