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Controlled Clinical Trial
. 2016 Jun;13(3):343-8.
doi: 10.1111/iwj.12309. Epub 2014 Jun 3.

A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients

Rajeshwar N Srivastava  1 , Mukesh K Dwivedi  1 , Amit K Bhagat  2 , Saloni Raj  3 , Rajiv Agarwal  4 , Abhijit Chandra  2
Affiliations
Controlled Clinical Trial

A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients

Rajeshwar N Srivastava et al. Int Wound J. 2016 Jun.

Abstract

The conventional methods of treatment of pressure ulcers (PUs) by serial debridement and daily dressings require prolonged hospitalisation, associated with considerable morbidity. There is, however, recent evidence to suggest that negative pressure wound therapy (NPWT) accelerates healing. The commercial devices for NPWT are costly, cumbersome, and electricity dependent. We compared PU wound healing in traumatic paraplegia patients by conventional dressing and by an innovative negative pressure device (NPD). In this prospective, non-randomised trial, 48 traumatic paraplegia patients with PUs of stages 3 and 4 were recruited. Patients were divided into two groups: group A (n = 24) received NPWT with our NPD, and group B (n = 24) received conventional methods of dressing. All patients were followed up for 9 weeks. At week 9, all patients on NPD showed a statistically significant improvement in PU healing in terms of slough clearance, granulation tissue formation, wound discharge and culture. A significant reduction in wound size and ulcer depth was observed in NPD as compared with conventional methods at all follow-up time points (P = 0·0001). NPWT by the innovative device heals PUs at a significantly higher rate than conventional treatment. The device is safe, easy to apply and cost-effective.

Keywords: Negative pressure wound therapy; Out patient department procedure; Pressure ulcer; Traumatic paraplegia.

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Figures

Figure 1
Figure 1
(A) The perforated end of the Romovac drainage tube is placed on the wound surface. (B) Sterilised foam is placed on top of the wound. (C) Opsite covers the wound with an airtight seal. (D) The other end of the drainage tube is connected to Romovac.
Figure 2
Figure 2
Evaluation of discharge and pathogenic organisms (culture positive to culture negative) in both groups at different time intervals [significant reduction (P = 0·0001) from 0 week to weeks 3, 6 and 9 in group A, McNemar's test]. Group A, negative pressure wound therapy; group B, conventional methods of dressing.
See this image and copyright information in PMC

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