Chlorhexidine-alcohol versus iodine-alcohol for surgical site skin preparation in an elective arthroplasty (ACAISA) study: a cluster randomized controlled trial.

Surgical site skin preparation is an effective method to prevent wound complications. The optimal agent has not been established, and guidelines contain conflicting recommendations. The aim of alcoholic chlorhexidine or alcoholic iodine skin antisepsis (ACAISA) was to assess the efficacy of surgical site skin preparation with 0.5% chlorhexidine gluconate (w/v) in 70% ethanol (v/v) to 1% iodine (w/v) in 70% ethanol (v/v). This was a cluster randomized, controlled, single-centre, assessor-blinded, superiority trial in patients undergoing elective hip or knee arthroplasty. Each surgeon had a set operating day and the unit of randomization was the day of surgery. The primary outcome was superficial wound complication, defined as a composite endpoint of superficial incisional surgical site infection and/or clinically significant wound ooze in the 30 days following arthroplasty. The secondary outcome was any surgical site infection, including prosthetic joint infection. Outcome ascertainment was undertaken by an independent verification panel. The primary analysis was intention-to-treat, performed at the individual level. Taking into account the clustering effect, analysis of primary and secondary outcomes was undertaken at the level of the surgeon. A total of 780 participants were included; 390 participants were allocated chlorhexidine-alcohol and 390 participants were allocated iodine-alcohol. There was no difference in superficial wound complications: 19 (4.9%) versus 15 (3.8%) respectively (OR 1.28; 95%CI 0.62, 2.63; p 0.50). There was an increased odds of surgical site infection in the chlorhexidine-alcohol group compared to iodine-alcohol: 12 (3.1%) versus four (1.0%) respectively (OR 3.06; 95%CI 1.26, 7.46; p 0.014). The odds of prosthetic joint infection were also increased in the chlorhexidine-alcohol arm compared with iodine-alcohol: seven (1.8%) versus two (0.5%) respectively (OR 3.55; 95%CI 1.20, 10.44; p 0.022). No difference was observed in the primary outcome of superficial wound complications when chlorhexidine-alcohol and iodine-alcohol were compared. However, on a secondary analysis, iodine-alcohol had greater efficacy than chlorhexidine-alcohol for preventing surgical site infection. Australian New Zealand Clinical Trials Registry ACTRN12614000177651.

Peel TN ，Dowsey MM ，Buising KL ，Cheng AC ，Choong PFM ... -  《-》

Alcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis (ACAISA): protocol for cluster randomised controlled trial of surgical skin preparation for the prevention of superficial wound complications in prosthetic hip and knee replacement surgery.

Wound complications following arthroplasty are associated with significant impact on the patient and healthcare system. Skin cleansing prior to surgical incision is a simple and effective method to prevent wound complications however, the question of which agent is superior for surgical skin antisepsis is unresolved. This cluster randomised controlled trial aims to compare the incidence of superficial wound complications in patients undergoing elective prosthetic hip or knee replacement surgery receiving surgical skin antisepsis with either: 0.5% chlorhexidine gluconate (CHG) in 70% alcohol or 10% povidone in 70% alcohol. The trial will be conducted at an Australian tertiary, university affiliated hospital over a 3-year period involving 750 participants. Participants will be drawn from the surgical waiting list. Consent for this study will be 'opt-out' consent. On a given day, all eligible participants will have skin preparation either with 0.5% chlorhexidine in 70% alcohol or 10% povidone iodine in 70% alcohol. The primary outcome is superficial wound complications (comprised of superficial incisional surgical site infections (SSI) and/or prolonged wound ooze) in the first 30 days following prosthetic joint replacement surgery. Secondary outcomes will include the incidence of wound complications according to the joint replaced, assessment of the causative agents of SSI and cost-effectiveness analysis. The primary analysis is an intention-to-treat analysis including all participants who undergo randomisation and will be performed at the individual level taking into account the clustering effect. The study design and protocol was reviewed and approved by the St Vincent's Hospital Human Research Ethics Committee (HREC-A 016/14 10/3/2014). Study findings will be disseminated in the printed media, and learned forums. A written lay summary will be available to study participants on request. The trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000177651.

Peel TN ，Cheng AC ，Buising KL ，Dowsey MM ，Choong PF ... -  《BMJ Open》

A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial.

Identification of optimal surgical site antisepsis preparations may reduce cesarean-related surgical site infections. Two recently published investigations examined efficacy of chlorhexidine-alcohol and iodine-alcohol preparations. No previous randomized controlled trial has compared chlorhexidine-alcohol to povidone-iodine aqueous scrub and paint in reduction of cesarean-related surgical site infection. The purpose of the study was to determine if chlorhexidine-alcohol would result in fewer surgical site infections than povidone-iodine when used as skin antisepsis preparation prior to cesarean delivery. This study was a single-center pragmatic randomized controlled trial at an urban tertiary care institution to compare chlorhexidine-alcohol 26-mL single-step applicator to povidone-iodine aqueous scrub and paint 236-mL wet skin tray as preoperative skin antiseptic preparation for women undergoing cesarean delivery. Patients were eligible for study participation if they could provide informed consent in English or Spanish, were ≥18 years of age, did not have clinical chorioamnionitis, were unlikely to be lost to follow-up, and had no sensitivities to chlorhexidine, betadine, or iodine. Treatment was assigned by computer-generated simple 1:1 randomization immediately before skin preparation. The primary outcome was surgical site infection occurring within 30 days of cesarean delivery including ≥1 of: superficial or deep surgical site infection, or endometritis, according to Centers for Disease Control and Prevention definitions. Analysis was by intent to treat. Categorical outcomes were compared using Fisher exact test. The Wilcoxon rank-sum test was performed for continuous outcomes. This trial was institutional review board approved and registered at ClinicalTrials.gov (NCT02202577). In all, 932 subjects (461 assigned to chlorhexidine-alcohol, 471 assigned to povidone-iodine) were randomized from February 2013 through May 2016. Rate of follow-up evaluation after 30 days was 99% (455) in the chlorhexidine-alcohol group and 97% (455) in the povidone-iodine group. Surgical site infection occurred in 29 (6.3%) of the chlorhexidine-alcohol group and 33 (7.0%) in the povidone-iodine group (P = .38). The rates of individual components of the primary outcome were as follows: superficial surgical site infection (4.6% v 5.5%; P = .55), deep surgical site infection (0.0% v 0.4%; P = .50), and endometritis (1.7% v 1.1%; P = .42) in chlorhexidine-alcohol vs povidone-iodine arms, respectively. All results were similar in per protocol analysis. Preoperative antiseptic skin preparation with chlorhexidine-alcohol 26-mL single-step applicator before cesarean did not result in less frequent surgical site infection when compared with povidone-iodine aqueous scrub and paint 236-mL wet skin preparation tray. Povidone-iodine should still be considered as acceptable for preoperative surgical site antisepsis for cesarean delivery.

Springel EH ，Wang XY ，Sarfoh VM ，Stetzer BP ，Weight SA ，Mercer BM ... -  《-》

Antisepsis of the skin before spinal surgery with povidone iodine-alcohol followed by chlorhexidine gluconate-alcohol versus povidone iodine-alcohol applied twice for the prevention of contamination of the wound by bacteria: a randomised controlled trial.

The aim of this study was to determine whether the sequential application of povidone iodine-alcohol (PVI) followed by chlorhexidine gluconate-alcohol (CHG) would reduce surgical wound contamination to a greater extent than PVI applied twice in patients undergoing spinal surgery. A single-centre, interventional, two arm, parallel group randomised controlled trial was undertaken, involving 407 patients who underwent elective spinal surgery. For 203 patients, the skin was disinfected before surgery using PVI (10% [w/w (1% w/w available iodine)] in 95% industrial denatured alcohol, povidone iodine; Videne Alcoholic Tincture) twice, and for 204 patients using PVI once followed by CHG (2% [w/v] chlorhexidine gluconate in 70% [v/v] isopropyl alcohol; Chloraprep with tint). The primary outcome measure was contamination of the wound determined by aerobic and anaerobic bacterial growth from samples taken after disinfection. The detection of viable bacteria in any one of the samples taken after disinfection (culture-positive) was significantly lower in the group treated with both PVI and CHG than in the group treated with PVI alone (59 (29.1%) versus 85 (41.7%), p = 0.009; odds ratio 0.574; 95% confidence interval, 0.380 to 0.866). Antisepsis of the skin with the sequential application of PVI and CHG more effectively reduces the contamination of a surgical wound than PVI alone. Cite this article: Bone Joint J 2017;99-B:1354-65.

Patrick S ，McDowell A ，Lee A ，Frau A ，Martin U ，Gardner E ，McLorinan G ，Eames N ... -  《-》

Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for Preoperative Skin Antisepsis: A Randomized Clinical Trial.

Widmer AF ，Atkinson A ，Kuster SP ，Wolfensberger A ，Klimke S ，Sommerstein R ，Eckstein FS ，Schoenhoff F ，Beldi G ，Gutschow CA ，Marschall J ，Schweiger A ，Jent P ... -  《-》