BACKGROUND CONTEXT Treatment of pressure injury (PI) is an ongoing clinical challenge particularly in people with SCI in developing countries where socioeconomic conditions often dictate treatment modalities. When negative pressure wound therapy (NPWT) was introduced, there were a series of devices (V.A.C., KCI, San Antonio, TX) manufactured. These devices for NPWT are costly and hard to afford by patients in developing countries like India and others. Commercially available devices are typically rented and require costly consumables. This study focuses on a novel, bellows-powered negative pressure device (NPD) that is easy to apply and does not require electricity. PURPOSE The purpose of this study was to evaluate wound-healing outcome measures (length, width, and depth, exudate amount, and tissue type) in PIs of spinal cord-injured patients treated with NPWT using a novel negative pressure device versus PI treated with wet-moist gauze (conventional wound care). STUDY DESIGN/SETTING Randomized controlled clinical trail (RCT) Department of Orthopaedic Surgery, King George's Medical University, Lucknow, India. This RCT was registered and approved by our institutional ethics committee. PATIENT SAMPLE Thirty-four (34) spinal cord injury subjects resulting traumatic paraplegia. OUTCOME MEASURES The outcome measures were surface area (length X width) and depth of PI, granulation tissue formation, exudates, microorganisms and cost effectivenes sat week 0, 3, 6 and week 9. METHODS Conventional therapy in our facility comprises wet to moistgauze dressings, and this intervention was used for comparison to the experimental intervention (NPWT via bellows enhanced vacuum device). The NPD dressing was changed weekly or more often if the dressing became saturated or loss of suction occurred. RESULTS Significantly reduced length of PI in NPWT group was observed at week 6 (p=.04) which further reduced at week 9 (p=.001) as compared to conventionally treated group. Similarly significant reduction of width and depth of PI was observed in NPWT at week 9 (p CONCLUSIONS NPWT by our locally constructed indigenized novel NPD is better wound care procedure and cost effective for management of pressure injury. We also found that the NPD reduced wound exudate, cleared slough, and accelerated the formation of red granulation tissue. Improving basic knowledge of NPWT in the management of PIs may help clinicians and wound care researchers identify and proactively intervene in an effort to minimize the time and cost associated with PI healing in SCI patients.
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