Closed‐incision negative pressure therapy to reduce groin wound infections in vascular surgery: a randomised controlled trial

Abstract

Groin wound infections pose a major problem in vascular surgery. Closed-incision negative pressure therapy (ciNPT) was especially designed for the management of incisions at risk of surgical site infections. The aim of this study was to investigate whether ciNPT is able to reduce the incidence of wound infections after vascular surgery. Data on 132 consecutive patients, scheduled for vascular surgery with a longitudinal femoral cutdown, were collected prospectively. All patients were randomised either to the ciNPT group (n = 64) or the control group (n = 68) with conventional dressing. In the ciNPT group, the foam dressing was applied intraoperatively and removed after 5 days. The control group received an absorbent dressing. All wounds were evaluated after 5 and 42 days. Infections were graded according the Szilagyi classification (I-III°). There were no significant differences between both groups considering patient characteristics. Indications for surgery were peripheral arterial disease in 95% (125/132) and aneurysm in 5% (7/132). The overall infection rates were 14% (9/64) in the ciNPT group and 28% (19/68) in the control group (P = 0·055). Early infections were observed in 6% (4/64) of the ciNPT group and 15% (10/68) of the control group (P = 0·125). ciNPT did not reduce infection rates associated with different risk factors for infection. While the experiences with the ciNPT device were encouraging, the study fails to provide evidence of the efficacy of the device to reduce groin wound infections after vascular surgery. It illustrates far more that larger multicentre studies are required and appear promising to provide further evidence for the use of ciNPT.

A systematic review and meta-analysis of randomized controlled trials for the reduction of surgical site infection in closed incision management versus standard of care dressings over closed vascular groin incisions

“…Two studies were at high risk of outcomes assessment bias as the outcomes assessments were not blinded. 11,18 Assessment bias was low in all five published manuscripts 3,11,15,16,18 compared to the published abstract which did not provide sufficient information to correctly make an assessment. 17 Three studies 11,16,18 were low risk for selective reported, but it was unclear for the remaining three studies (Table 3).…”

“…Of the six studies, two reported no device failures or adverse effects of the device. 11,15 One study reported that one patient had the device removed early owing to an inability to achieve an adequate seal postoperatively. 16 Three studies did not include information on device failure or adverse effects of the device.…”

“…Two studies did not restrict patient enrollment to patients deemed at high risk for SSI development. 15,17 Despite randomization, three studies reported significant differences in baseline characteristics. Higher rates of possible SSI risk factors were found in the ciNPT treatment arms.…”

“…One RCT was multicenter, 11 while the rest were performed at a single center. 3,15–18 The Kwon et al. study was an interim analysis conducted after 80% of planned enrollment; the study met the prespecified stopping guideline and was stopped at the interim analysis prior to full enrollment.…”

“…In four of the six studies, the authors adequately described the randomization methods and the allocation masking and were considered low risk of selection bias. 11,15,16,18 All six studies had a high risk for bias due to the inability to blind participants and personnel to treatment due to the ciNPT device. Two studies were at high risk of outcomes assessment bias as the outcomes assessments were not blinded.…”