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Pressure ulcer management in paraplegic patients with a novel negative pressure device: a randomised controlled trial

    Abstract

    Objective:

    A randomised controlled trial to compare negative pressure wound therapy (NPWT) using our innovative negative pressure device (NPD) and the standard pressure ulcer (PU) wound dressing of in traumatic paraplegia patients.

    Method:

    This study was conducted in the Department of Orthopaedic Surgery at King George's Medical University, Lucknow, India. Traumatic paraplegia patients with sacral pressure ulcers of stage 3 and 4 were randomised into two groups, receiving either standard wound dressings or NPWT with NPD. The outcomes monitored were length, width (surface area), depth of PU, exudates, discharge, tissue type (necrotic, slough and red granulating tissue), and cost-effectiveness during 0 to 9 weeks follow-up.

    Results:

    Length and width were significantly (p<0.01) decreased in NPWT group as compared with standard care group at week 9. At weeks 1, 2 and 3, depth was significantly (p<0.05) higher in NPWT group, whereas at week 9 a significant reduction (p=0.01) was observed. Exudates were significantly (p=0.001) lower in NPWT group at weeks 4 and 9. Conversion of slough into red granulation tissue was significantly higher in NPWT group (p=0.001). Discharge became significantly (p=0.001) lower in NPWT at week 2 and no discharge was observed after week 6. In all parameters, decrease was larger in NPWT group compared with standard care, which was significant for exudates type (p=0.03) and tissue type (p=0.004).

    Conclusion:

    Our NPD is better than standard wound care procedures and cost-effective for management of PU.

    References

    • 1 Thomas, D.R Prevention and treatment of pressure ulcers: What works? What doesn't? Cleveland Clin J Med 2001; 68: 8, 704–707. Crossref, MedlineGoogle Scholar
    • 2 Srivastava, R.N, Dwivedi, M.K, Bhagat, A.K et al. A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients. Int Wound J 2014; DOI: https://doi.org/10.1111/iwj.12309. Google Scholar
    • 3 Venturi, M.L, Attinger, C.E, Mesbahi, A.N et al. Mechanisms and clinical applications of the vacuum-assisted closure (VAC) device: a review. Am J Clin Dermatol 2005; 6: 3, 185–194. Crossref, MedlineGoogle Scholar
    • 4 Majumdar, R., Kothari, S.Y, Gupta, A. Challenges in the Management of Pressure Ulcers. IJPMR. 2006; 17: 1, 1–4. Google Scholar
    • 5 Basson, M.D, Burney, R.E Defective wound healing in patients with paraplegia and quadriplegia. Surg Gynecol Obstet 1982; 155: 1, 9–12. MedlineGoogle Scholar
    • 6 1 Morykwas, M.J, Argenta, L.C, Shelton-Brown, E.I, McGuirt, W. Vacuum-assisted closure: A new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg 1997; 38: 6, 553–562. Crossref, MedlineGoogle Scholar
    • 7 Plikaitis, C.M, Molnar, J.A Subatmospheric pressure wound therapy and the vucuum-assisted closure device: basic science and current clinical successes. Expert Rev Med Devices 2006; 3: 2, 175–184. Crossref, MedlineGoogle Scholar
    • 8 Genecov, D.G, Schneider, A.M, Morywas, M.J et al. A controlled subatmospheric dressing increases the rate of skin graft donor site re-epithelialization. Ann Plast Surg 1998; 40: 3, 219–225. Crossref, MedlineGoogle Scholar
    • 9 Dealey, C., Posnett, J., Walker, A. The cost of pressure ulcers in the United Kingdom. J Wound Care 2012; 21: 6, 261–264. LinkGoogle Scholar
    • 10 Fisher, A., Brady, B. (2003) Vacuum assisted closure therapy. Canadian Coordinating Centre for Health Technology Assessment. Available at: bit.ly/1nIKSXn (accessed March 2016). Google Scholar
    • 11 Pham, C., Middleton, P., Maddern, G. Vacuum-assisted closure for the management of wounds: an accelerated systematic review. ASERNIP-S Report No. 37. ASERNIP-S, 2003. Google Scholar
    • 12 Ashby, R.L, Dumville, J.C, Soares, M.O et al. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers. Trials 2012; 13: 119. MedlineGoogle Scholar
    • 13 National Pressure Ulcer Advisory Panel & European Pressure Ulcer Advisory Panel (2014). Prevention and treatment of pressure ulcers: Clinical Practice Guideline. NPUAP and EPUAP Avaialble at: http://bit.ly/17A4p4b (accessed December 2015). Google Scholar
    • 14 Pressure Ulcer Scale for Healing (PUSH Tool) Version 3.0. (2003) Reprinted with permission from NPUAP. Available at: bit.ly/1lzb3wU (accessed March 2016). Google Scholar
    • 15 Xakellis, G.C, Frantz, R., Lewis, A. Cost of pressure ulcer prevention in long-term care. J Am Geriatr Soc 1995; 43: 5, 496–501. Crossref, MedlineGoogle Scholar
    • 16 Argenta, L.C, Morykwas, M.J Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg 1997; 38: 6, 563–576. Crossref, MedlineGoogle Scholar
    • 17 Deva, E.K, Buckland, G.H, Fisher, E. et al. Topical negative pressure in wound management. Med J Aust 2000; 173: 3, 128–131. Crossref, MedlineGoogle Scholar
    • 18 Mody, G.N, Nirmal, I.A, Duraisamy, S., Perakath, B. A Blinded, Prospective, Randomised Controlled Trial of Topical Negative Pressure Wound Closure in India. Ostomy Wound Manage 2008; 54: 12, 36–46. MedlineGoogle Scholar
    • 19 Moues, C.M, Van Den Bemd, G.J, Hovius, S.E Comparing conventional gauze therapy to vacuum-assisted closure wound therapy: a prospective randomised trial. J Plast Reconstr Aesthet Surg 2007; 60: 6, 672–681. Crossref, MedlineGoogle Scholar
    • 20 Wanner, M.B, Schwarzl, F., Strub, B. et al. Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: a prospective study. Scand J Plast Reconstr Surg Hand Surg 2003; 37: 1, 28–33. Crossref, MedlineGoogle Scholar
    • 21 Yarkony, G.M, Chen, D. Rehabilitation of patients with spinal cord injuries. In: Braddom, R.L (eds). Physical medicine and rehabilitation. WB Saunders. 1996; 1149–1179. Google Scholar
    • 22 Stechmiller, J.K, Kilpadi, D.V, Childress, B., Schultz, G.S Effect of Vacuum-Assisted Closure Therapy on the expression of cytokines and proteases in wound fluid of adults with pressure ulcers. Wound Repair Regen 2006; 14: 3, 371–374. Crossref, MedlineGoogle Scholar
    • 23 Apelqvist, J., Armstrong, D.G, Lavery, L.A, Boulton, A.J Resource utilization and economic costs of care based on a randomised trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am J Surg 2008; 195: 6, 78–28. Crossref, MedlineGoogle Scholar
    • 24 Philbeck, T.E Jr., Whittington, K.T, Millsap, M.H et al. The clinical and cost effectiveness of externally applied negative pressure wound therapy in the treatment of wounds in home healthcare Medicare patients. Ostomy Wound Manage. 1999; 45: 11, 41–50. MedlineGoogle Scholar
    • 25 Armstrong, D.G, Lavery, L.A, Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation. A multicentre, randomized controlled trial. Lancet 2005; 366: 9498, 1704–1710. Crossref, MedlineGoogle Scholar
    • 26 Greene, A.K, Puder, M., Roy, R. et al. Microdeformational wound therapy: effects on angiogenesis and matrix metalloproteinases in chronic wounds of 3 debilitated patients. Ann Plast Surg 2006; 56: 4, 418–422. Crossref, MedlineGoogle Scholar
    • 27 Weed, T., Ratliff, C., Drake, D.B Quantifying bacterial bioburden during negative pressure wound therapy: does the wound VAC enhance bacterial clearance? Ann Plast Surg 2004; 52: 3, 276–279. Crossref, MedlineGoogle Scholar

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