Simplified Negative Pressure Wound Therapy Device for Application in Low-Resource Settings

Abstract

Negative pressure wound therapy (NPWT) provides proven wound healing benefits and is often a desirable wound treatment. Unfortunately, NPWT devices are not widely available in low-resource settings (LRSs). In order to overcome identified NPWT barriers, a simplified NPWT (sNPWT) system was designed and iteratively improved during field-based testing. The sNPWT technology, our device design iterations, and the design-based results of our field tests are described. The sNPWT system includes a bellows hand pump, an occlusive drape, and a tube with tube connectors, connecting the drape to the pump. The most critical property of a sNPWT system is that it must be airtight. The details of the design iterations needed to achieve an occlusive system are explained. During the design process, the sNPWT system was tested during the earthquake relief in Haiti. This testing found that a liquid sealant was necessary to seal the drape to the peri-wound skin. A study conducted in Rwanda verified that a liquid latex sealant was safe to use and that the tube connector must be connected to the drape with an airtight method during the manufacturing process. This work has shown that sNPWT is feasible in LRSs. Since the completion of the clinical testing, the design has been further evolved and the developers are working with contract manufactures to produce the final design and preparing for regulatory approval applications.