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Report of Phase I Results of a Simplified Negative Pressure Wound Therapy Device for Use in Low Resource Settings
Gita N. Mody, MD1, Danielle R. Zurovcik, MD2, Grace Kansayisa, MD3, Gemimah Uwimana, MD4, Dominque Mugenzi, MD3, Georges Natkiyiruta, MD3, Robert Riviello, MD1
1Department of Surgery and the Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, MA; 2Massachusetts Institute of Technology, Cambridge, MA; 3Central University Teaching Hospital, National University of Rwanda; 4Department of Nursing, Rwinkwavu District Hospital, Rwinkwavu, Rwanda
Background: Negative pressure wound therapy (NPWT) has been shown to heal wounds faster than conventional dressings; however, NPWT is too costly for application in low-resource settings (LRSs). A simplified NPWT (sNPWT) device was tested for safety and feasibility in Rwanda.
Methods: Study endpoints were the maintenance of negative pressure and occurrence of adverse events. Twenty-six patients were enrolled over 6 months. An occlusive dressing was sealed over the gauze-packed wound cavity, and a drainage tube was attached to a bellows, which generated 75 mmHg negative pressure. Negative pressure delivery was measured twice a day.
Results: The initial dressing prototype was iteratively modified 4 times over the course of the study. 100% of the first 10 dressings failed within 24 hours, resulting in modifications to the method of sealing the dressing. 46% of the next 13 dressings failed within 24 hours, prompting a change in integrating the tubing into the dressing. 33% of the next 9 dressings applied failed in 24 hours, however tube occlusion was detected, and the tube connector and tip were modified. The final dressing prototype maintained negative pressure for 24 hours or more in 74% of 19 applications with 4 dressings reaching the target of 72 hours. Mean duration of negative pressure was 37.2 hours (SD +/-26.3). There was one adverse event.
Conclusion: This is the first report of NPWT device performance as measured by maintenance of negative pressure during application to patients. These results show sNPWT is feasible and safe for use in LRSs.
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