title: A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients.
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.
authors.affiliation: Department of Orthopaedic Surgery, King George's Medical University (KGMU), Lucknow, India.
authors.forename: Rajeshwar N
authors.initials: RN
authors.lastname: Srivastava
authors.affiliation: Department of Orthopaedic Surgery, King George's Medical University (KGMU), Lucknow, India.
authors.forename: Mukesh K
authors.initials: MK
authors.lastname: Dwivedi
authors.affiliation: Department of Surgical Gastroenterology, King George's Medical University (KGMU), Lucknow, India.
authors.forename: Amit K
authors.initials: AK
authors.lastname: Bhagat
authors.affiliation: MS Ramiyah Medical College, Bangalore, India.
authors.forename: Saloni
authors.initials: S
authors.lastname: Raj
authors.affiliation: Department of Plastic Surgery, King George's Medical University (KGMU), Lucknow, India.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
authors.affiliation: Department of Surgical Gastroenterology, King George's Medical University (KGMU), Lucknow, India.
authors.forename: Abhijit
authors.initials: A
authors.lastname: Chandra
mesh_terms: D001458:Bandages; D006801:Humans; D054843:Negative-Pressure Wound Therapy; D010264:Paraplegia; D003668:Pressure Ulcer; D011446:Prospective Studies
keywords: Negative pressure wound therapy; Out patient department procedure; Pressure ulcer; Traumatic paraplegia