title: 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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  Our NPD is better than standard wound care procedures and cost-effective for management of PU.
authors.affiliation: Department of Orthopaedic Surgery, King George's Medical University, Lucknow, U.P., India.
authors.forename: M K
authors.initials: MK
authors.lastname: Dwivedi
authors.affiliation: Department of Orthopaedic Surgery, King George's Medical University, Lucknow, U.P., India.
authors.forename: R N
authors.initials: RN
authors.lastname: Srivastava
authors.affiliation: Department of Surgical Gastroenterology, King George's Medical University, Lucknow, U.P., India.
authors.forename: A K
authors.initials: AK
authors.lastname: Bhagat
authors.affiliation: Sanjai Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow, India.
authors.forename: R
authors.initials: R
authors.lastname: Agarwal
authors.affiliation: Department of Orthopaedic Surgery, King George's Medical University, Lucknow, U.P., India.
authors.forename: K
authors.initials: K
authors.lastname: Baghel
authors.affiliation: Department of Microbiology, King George's Medical University, Lucknow, U.P., India.
authors.forename: A
authors.initials: A
authors.lastname: Jain
authors.affiliation: MS Ramiyah Medical College, Bangalore, India.
authors.forename: S
authors.initials: S
authors.lastname: Raj
mesh_terms: D000328:Adult; D001458:Bandages; D019468:Disease Management; D005122:Exudates and Transudates; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D054843:Negative-Pressure Wound Therapy / Q000295:instrumentation* / Q000379:methods; D010264:Paraplegia / Q000150:complications; D003668:Pressure Ulcer / Q000150:complications / Q000628:therapy*; D012445:Sacrococcygeal Region; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
keywords: negative pressure device; negative pressure wound therapy; pressure ulcer