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, Mukesh K Dwivedi, Amit K Bhagat, Saloni Raj, Rajiv Agarwal, Abhijit Chandra, Rajeshwar N Srivastava, Mukesh K Dwivedi, Amit K Bhagat, Saloni Raj, Rajiv Agarwal, Abhijit Chandra

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.

© 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

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.

References

    1. Kuffler DP. Techniques for wound healing with a focus on pressure ulcers elimination. Open Circ Vasc J 2010;3:72–84.
    1. Sella EJ, Barrette C. Staging of Charcot neuroarthropathy along the medial column of the foot in the diabetic patient. J Foot Ankle Surg 1999;38:34–40.
    1. Levine JM. Historical perspective: the neurotrophic theory of skin ulceration. J Am Geriatr Soc 1992;40:1281–3.
    1. Levine JM. Historical perspective on pressure ulcers: the decubitus ominosus of Jean‐Martin Charcot. J Am Geriatr Soc 2005;53:1248–51.
    1. Venturi ML, Attinger CE, Mesbahi AN, Hess CL, Graw KS. Mechanisms and clinical applications of the vacuum‐assisted closure (VAC). Am J Clin Dermatol 2005;6:185–94.
    1. Stover SL, Fine PR. Spinal cord injury. The facts and figures. Birmingham: University of Alabama at Gary M. Yarkony, David Chen. Rehabilitation of patients with spinal cord injuries. Randall LB. Text book of physical medicine and rehabilitation. Philadelphia: WB Saunders; 1996:1149–79.
    1. Basson MD, Burney RE. Defective wound healing in patients with paraplegia and quadriplegia. Surg Gynecol Obstet 1982;155:9–12.
    1. Plikaitis CM, Molnar JA. Subatmospheric pressure wound therapy and the vucuum‐assisted closure device: basic science and current clinical successes. Expert Rev Med Devices 2006;3:175–84.
    1. National Pressure Ulcer Advisory Panel . Pressure ulcers, incidence, economics, risk assessment. West Dundee: National Pressure Ulcer Advisory Panel, 2009.
    1. Deeks JJ, Dinners J, D'Amico R, Swoden AJ, Sakarovitch C, Song F, Pettricrew M, Altman DG. Evaluating non randomized interventional studies. Health Technol Assess 2003;7:P‐2.
    1. Thomas DR. Prevention and treatment of pressure ulcers. J Am Med Dir Assoc 2006;7:46–59.
    1. Genecov DG, Schneider AM, Morywas MJ. A controlled subatmospheric dressing increases the rate of skin graft donor site reepithelialization. Ann Plast Surg 1998;40:219–25.
    1. Morykwas MJ, Argenta LC, Shelton Brown EI, McGuirt W. Vacuum‐assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg 1997;38:553–62.
    1. Moues CM, Vos MC, Van den Bemd GJ, Stijnen T, Hovius SE. Bacterial load in relation to vacuum‐assisted closure wound therapy: a prospective randomized trial. Wound Repair Regen 2004;12:11–7.
    1. Yarkony GM, Chen D. Rehabilitation of patients with spinal cord injuries. In: Randall LB, editor. Text book of physical medicine and rehabilitation. Philadelphia: WB Saunders, 1996:1149–79.
    1. Mody GN, Nirmal IA, Duraisamy S, Perakath B. A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India. Ostomy Wound Manage 2008;54:36–46.
    1. Chen SZ, Li J, Li XY, Xu LS. Effects of vacuum‐assisted closure on wound microcirculation: an experimental study. Asian J Surg 2005;28:211–7.
    1. Hirsch GH, Menard MR, Anton HA. Anemia after traumatic spinal cord injury. Arch Phys Med Rehabil 1991;72:195–201.
    1. Allman RM. Pressure ulcers among the elderly. N Engl J Med 1989;320:850–3.

Source: PubMed

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