Closed incision negative pressure therapy (ciNPT) was found to reduce surgical site infections (SSI) in vascular surgery, according to the results of a prospective, randomized, industry-sponsored trial of patients who underwent vascular surgery for peripheral artery disease (PAD) published online in the European Journal of Vascular and Endovascular Surgery.
The investigator-initiated Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System trial (NCT02395159) included 204 patients who underwent vascular surgery involving longitudinal groin incision to treat the lower extremity or the iliac arteries between July 2015 and May 2017 at two study centers.
The primary endpoint was the occurrence of SSI assessed by the Szilagyi classification (grades I-III). The mean patient age was nearly 67 years and 70% were men. In terms of PAD staging, 52% were stage 2B, 28% were stage 3, and 19% were stage 4. Among the patients, 45% had a previous groin incision and 42% had diabetes.
All patients underwent similar preoperative treatment: hair shaving and preparation with Poly Alcohol (Antiseptica, Pulheim, Germany) and Braunoderm (Braun, Melsungen, Germany). At 30 minutes preincision, patients received intravenous antibiotic treatment (1.5 g cefuroxime or 600 mg clindamycin, if allergic to penicillin). After closure, the incision and surrounding skin area was cleaned and dried using sterile gauze. In the control group, a sterile adhesive wound dressing was applied to the wound, which was changed daily. In the treatment group, ciNPT was applied under sterile conditions in the operating room using the Prevena device, which exerts a continuous negative pressure of 125 mm Hg on the closed incision during the time of application. The device was removed at 5-7 days postoperatively, and no further wound dressings were used in the treatment group unless an SSI occurred.
The control group experienced more frequent SSIs (33.3%) than the intervention group (13.2%) (P =.0015). This difference was based on an increased rate of Szilagyi grade I SSI in the control group (24.6% vs. 8.1%, P = .0012), according to Alexander Gombert, MD, of the University Hospital Aachen (Germany), and his colleagues. The absolute risk difference based on the Szilagyi classification was –20.1 per 100 (95% confidence interval, –31.9 to –8.2).
In addition, there was a statistically significantly lower rate of SSI when using ciNPT within the subgroups at greater risk of infection, compared with controls: PAD stage greater than or equal to 3 (P less than .001), body mass index greater than 25 kg/m2 (P less than .001), and previous groin incision (P = .016).
There were no statistical differences between the two groups in Szilagyi grade II and III SSIs (which occurred in 5.8% of all procedures).
No potentially device-related complications were observed in the trial and there were no failures of the device seen.
“The use of ciNPT rather than standard wound dressing after groin incision as access for vascular surgery was associated with a reduced rate of superficial SSI classified by Szilagyi, suggesting that ciNPT may be useful for reducing the SSI rate among high-risk patients,” the researchers concluded.
The trial was funded by Acelity. Dr. Gombert received travel grants from Acelity.
SOURCE: Gombert A et al. Eur J Vasc Surg. 2018 Jul 2. doi: 10.1016/j.ejvs.2018.05.018.