The effect of preheated versus room-temperature skin disinfection on bacterial colonization during pacemaker device implantation: A randomized controlled non-inferiority trial

Abstract

Background: In clinical practice, patients who are awake often comment that cold surgical skin disinfectant is unpleasant. This is not only a problem of patients' experience; heat loss during the disinfection process is a problem that can result in hypothermia. Evidence for the efficacy of preheated disinfection is scarce. We tested whether preheated skin disinfectant was non-inferior to room-temperature skin disinfectant on reducing bacterial colonization during pacemaker implantation. Methods: This randomized, controlled, non-inferiority trial included 220 patients allocated to skin disinfection with preheated (36°C) or room-temperature (20°C) chlorhexidine solution in 70% ethanol. Cultures were obtained by swabbing at 4 time-points; 1) before skin disinfection (skin surface), 2) after skin disinfection (skin surface), 3) after the incision (subcutaneously in the wound), and 4) before suturing (subcutaneously in the wound). Results: The absolute difference in growth between patients treated with preheated versus room-temperature skin disinfectant was zero (90% CI -0.101 to 0.101; preheated: 30 of 105 [28.6%] vs. room-temperature: 32 of 112 [28.6%]). The pre-specified margin for statistical non-inferiority in the protocol was set at 10% for the preheated disinfectant. There were no significant differences between groups regarding SSIs three month postoperatively, which occurred in 0.9% (1 of 108) treated with preheated and 1.8% (2 of 112) treated with room-temperature skin disinfectant. Conclusion: Preheated skin disinfection is non-inferior to room-temperature disinfection in bacterial reduction. We therefore suggest that preheated skin disinfection become routine in clean surgery. Trial registration: The study is registered at ClinicalTrials.gov (NCTO2260479).