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

Abstract

BackgroundIn 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.MethodsThis 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).ResultsThe 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.ConclusionPreheated 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 registrationThe study is registered at ClinicalTrials.gov (NCTO2260479).

Povidone-iodine vs chlorhexidine alcohol for skin preparation in malignant and premalignant gynaecologic diseases: A randomized controlled study

“…In addition, pre-anesthetic skin warming will help to reduce the initial postinduction hypothermia and could prevent intraoperative hypothermia and postoperative shivering [36]. Wistrand et al compared preheated (36 C) and room temperature (20 C) chlorhexidine solutions on patients with pacemaker device implantation but did not find any difference in bacterial colonization or SSI rates [37]. The same authors investigated heat loss, bacterial growth and patient experiences with warm and cold chlorhexidine alcohol, and reported heat loss of 1.4 C and 2.5 C from baseline skin temperature, respectively.…”

Positive impact on heat loss and patient experience of preheated skin disinfection: a randomised controlled trial

“…The aim of the first part of the study was to evaluate bacterial growth (Wistrand et al . ). The study was performed at the Department of Cardiothoracic and Vascular Surgery at the University Hospital in Örebro, Sweden, between January 2013 and November 2014.…”

“…A sample size of 220 participants was chosen in the first part of this randomised controlled study and was based on the expected proportion of bacterial growth [(Wistrand et al . ) and (http://ClinicalTrials.gov, NCTO2260479)] following a power analysis and on experience gleaned from a previous pilot study (Wistrand & Nilsson ). The pilot study detected significant differences in both patients’ experiences and skin temperature; thus, we decided that 220 participants were sufficient to investigate patients’ experiences and skin temperature in the present study.…”

Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial

“…10,12 Preheated skin disinfectant can prevent heat loss on the skin and be as effective at reducing bacterial growth as room temperature skin disinfectant. 10,12,13 However, studies focusing on the sensations that patients experience during skin disinfection are lacking, and no other studies have investigated sensations other than temperature.…”