The Use of Iodine Impregnated Incision Drape in Knee Arthroplasty Surgery – A Prospective, Randomized Trial

Abstract

Background Periprosthetic joint infection (PJI) is a serious adverse event for the patient and has large socio-economic costs. Despite several efforts the infection rate has been the same for years. We performed an RCT study to investigate the effect of an iodine impregnated incision drape (IIID) on contamination rates with the intention to reduce subsequent infections.

Methods The investigation was a non-blinded, multicentre, randomised, controlled trial at five different hospitals in the capitol region (Region H) and the central Denmark Region (Region M). Twenty-four surgeons participated in the study. Participants were patients above 18 years of age, undergoing primary knee arthroplasty. Exclusion criteria were iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken four weeks prior to surgery and if the patient were unable to understand the implications of participating in the study. Patients were randomly assigned to operation with IIID (intervention group) or without IIID (control group). Patients were intraoperatively swabbed for bacteria at the surgical site and a rinse from the surgeons’ gloves was also sent for cultivation.

Findings Between Mar 1, 2016 and April 13, 2018, 1,187 patients were randomly assigned to treatment groups (603 to surgery with IIID, 584 to surgery without IIID). The overall contamination rate was 12·6% (150/1187). In the IIID group 60/603 (10%) patients were contaminated and 90/584 (15·4%) in the control group, OR 0·61 (95% CI 0·43-0·87, p=0·0048). Logistic regression analysis found that not using IIID increased risk of contamination by a factor of 1·6 (95% CI 1·08-2·35, p=0·02). Female sex and undergoing surgery in Region M had significantly lower odds of contamination, 0·53 (95% CI 0·36-0·78, p=0·0015) and 0·42 (95% CI 0·23-0·77, p=0·0048) respectively.

Interpretation The use of IIID results in significantly lower contamination rates compared with operation without IIID. Our findings show that the effect is measurable in males only.

Funding University of Copenhagen and 3M Health Care (St. Paul, Minnesota) funded the study. 3M did not participate in the design of the study, data collection, data analysis, data interpretation, or writing of the manuscript.

Keywords: intraoperative contamination, iodine impregnated incision drape