Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial

• Published in: European journal of vascular and endovascular surgery 2020-04, Vol.59 (4), p.635-641
• Main Authors: Wübbeke, Lina F., Telgenkamp, Bjorn, van Boxtel, Tiemen, Bolt, Lars J.J., Houthoofd, Sabrina, Vriens, Patrick W.H.E., Bouwman, Lee H., Mees, Barend M.E., Daemen, Jan Willem H.C.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Anti-Bacterial Agents - pharmacology; Antibiotic Prophylaxis - methods; Aortic Aneurysm, Abdominal - drug therapy; Aortic Aneurysm, Abdominal - surgery; Collagen - pharmacology; Endovascular Procedures - adverse effects; Female; Gentamicin containing collagen implant; Gentamicins - pharmacology; Groin - surgery; Humans; Inguinal incision; Male; Middle Aged; Randomised control trial; Surgical site infection; Surgical Wound Infection - drug therapy; Vascular surgery
• ISSN: 1078-5884; 1532-2165
• DOI: 10.1016/j.ejvs.2020.01.010

The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery. Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality. One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p