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.

Management of Grade IV Pressure Ulcers With a Novel Negative Pressure Device in Traumatic Paraplegia Subjects

“…Except in a sub-set of PUs, the authors did not find any statistically significant differences in the time to closure between the two treatment groups. They found a significant difference in time to closure of PU (mean 10±7.11 days) between the treatment and control groups (27±10.6 days, p=0.05) [1,2,4]. In our study, the reduction in surface area and depth of PUs treated by our NPD was faster than the PUs treated by standard wound care.…”

“…PUs are complex and chronic wounds in patients with SCI and no gold standard has yet been established for their prevention and treatment. PUs are difficult to prevent and manage and can lead to a decline in the overall well-being of patients in SCI [2,4,5,16]. In this study, the novel NPD proposed by us showed a statistically significant improvement in PU healing in terms of reduction in the surface area and depth, slough clearance, granulation tissue formation, and removal of exudate as compared with standard wound care.…”

“…This shows that PUs heal primarily from depth followed by length and width. The application of negative pressure over the wound bed allows the arterioles to dilate, increasing the effectiveness of local circulation, promoting angiogenesis, which assists in the proliferation of granulation tissue [4,9]. We observed that the patients on NPWT had the early appearance of granulation tissue as compared to the patients treated by conventional dressings.…”

“…Pressure ulcers (PUs) are wounds initiated by pressure on the skin that blocks circulation, causing the skin and underlying tissues to die [1,2]. PUs are a major health problem for bedridden patients with reduced mobility; patients with spinal cord injury (SCI) and associated co-morbidities are more prone to developing PUs with the incidence of 25%-66% [3][4][5][6]. Chronic wounds such as PUs are difficult to treat with available standard medical therapy and represent a burden on health care systems and also have a socio-economic impact on the patients and their caregivers.…”

Wound Healing Devices Brief Vignettes

“…A nonrandomized controlled trial comparing NPWT to conventional dressings showed a significant reduction in wound size with NPWT. 30 Another RCT that compared NPWT to modern dressings reported a reduction in the mean ulcer volume from 42% in controls to 52% for NPWT, not statistically significant ( p = 0.46). 31 Finally, a pro- Figure 1.…”