A randomized controlled clinical trial of innovative negative pressure device for the management of stage 3 and 4 pressure ulcer in traumatic paraplegia patients [CTRI/2014/09/0050]

Objective: A randomized controlled clinical trial to compare negative pressure wound therapy (NPWT) by our innovative negative pressure device (NPD) to conventional wound dressing of pressure ulcer (PU) in traumatic paraplegia patients.

Settings:This study was conducted in the Department of Orthopaedic Surgery at King George’s Medical University, Lucknow, India from March 2012 to March 2014.

Patients/Participants:44 traumatic paraplegia patients with sacral pressure ulcers of stage 3 & 4 were randomized into two groups: one (n=23) received conventional dressing and the other (n=21) received NPWT with NPD.

Main outcome variables: 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 to conventional group at 9^th week. At 1^st, 2^nd & 3^rd week, depth was significantly (p<0.05) higher in NPWT group, whereas at 9^th week significant reduction (p=0.01) was observed. Exudates were significantly (p=0.001) less in NPWT group at 4^th to 9^th week. 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 2^nd week and no discharge after 6^thweek. In all parameters, decrease was higher in NPWT group compared to conventional, which was significant for exudates type (p=0.03) and tissue type (p=0.004).

Conclusion: NPWT by our NPD is better wound care procedure and cost effective for management of PU.