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

摘要

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 ).