Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial

Obara, Hideaki; Takeuchi, Masashi; Kawakubo, Hirofumi; Shinoda, Masahiro; Okabayashi, Koji; Hayashi, Koki; Sekimoto, Yasuhito; Maeda, Yusuke; Kondo, Takayuki; Sato, Yasunori; Kitagawa, Yuko

doi:10.1016/s1473-3099(20)30225-5

Cited by 36 publications

(51 citation statements)

References 23 publications

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“…While Asukai et al performed a retrospective study in the eld of orthopedics, but found no signi cant difference between OLG and PVP-I [14]. On the other hand, Obara et performed a randomized study in clean contaminated gastrointestinal and hepatobiliary pancreatic surgery, found signi cant difference between OLG and PVP-I, which were nearly equivalent to our study [20]. Almost all clean surgeries performed in the orthopedic department were included in this study, and the rate of SSI was low; therefore, it was di cult to identify a difference.…”

Section: Discussionsupporting

confidence: 76%

Clinical Study of The Novel Antiseptic Olanexidine Gluconate in Gastrointestinal Cancer Surgery

Kubo¹,

Furusawa²,

Takeuchi³

et al. 2021

Preprint

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Background Surgical site infection (SSI) is a common complication of digestive surgery .Olanexidine gluconate (OLG) is a novel developed skin antiseptic and effective against a wide range of bacteria. The purpose of this study is to evaluate the bactericidal efficacy of OLG in gastrointestinal cancer surgery. Methods This retrospective study included a total of 281patients who underwent gastrointestinal cancer surgery (stomach or colon). There were two group: 223 patients were treated with OLG (OLG group), and 58 patients were treated with povidone-iodine (PVP-I) (control group). The efficacy and the safety outcomes were measured as the rate of surgical SSI within 30 days after surgery. In addition, we also conducted subgroups defined according to the surgical approach (open or laparoscopic) or primary lesion (stomach or colon). Results There was a significant difference in the rate of SSI between the control group and OLG group (10.3% vs. 2.7% ; p = 0.02). There was a significant difference in the SSI rate in superficial infection (8.6% vs. 2.2% ; p = 0.0345) but not in deep infection (1.7% vs. 0.5% ; p = 0.371). There was no significant difference between the control group and OLG group in the overall rate of adverse skin reaction (5.2% vs. 1.8% ; p = 0.157). Conclusion This retrospective study demonstrates that OLG is more effective than PVP-I for preventing SSI during gastrointestinal cancer surgery.

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Section: Discussionsupporting

confidence: 76%

Clinical Study of The Novel Antiseptic Olanexidine Gluconate in Gastrointestinal Cancer Surgery

Kubo¹,

Furusawa²,

Takeuchi³

et al. 2021

Preprint

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“…Five studies evaluated the effect on SSI prevention. 26 , 55 , 56 , 57 , 58 Two studies were RCTs, and three were retrospective observational studies. One study included children, and the remaining four studies included adults.…”

Section: Resultsmentioning

confidence: 99%

Clinical application of skin antisepsis using aqueous olanexidine: a scoping review

Shinzato

Sakihara

Kishihara

et al. 2022

Acute Medicine & Surgery

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Surgical site infections (SSIs) and catheter‐related bloodstream infections (CRBSIs) caused by bacteria from surfaces poorly disinfected with chlorhexidine gluconate (CHG) and povidone‐iodine (PVP‐I) are increasing. Olanexidine gluconate (OLG) was developed in 2015 in Japan to prevent SSI and CRBSI caused by bacteria resistant to CHG and PVP‐I. This scoping review aimed to identify the knowledge gap between what is known and what is not known about the disinfection efficacy of OLG. We searched MEDLINE through PubMed, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the International Clinical Trials Registry Platform search database, ClinicalTrials.gov , and the Web‐based database of Japanese medical articles for works published to July 18, 2021. Manual reference searches were also carried out. A total of 131 studies were screened. Forty‐seven studies were included in this review and classified into two major categories: studies on pharmacological effects and spectrum ( n = 29) and studies on clinical and adverse effects ( n = 18). Olanexidine gluconate showed bactericidal activity against methicillin‐resistant Staphylococcus aureus and vancomycin‐resistant enterococci, in addition to common Gram‐positive and Gram‐negative bacteria. In clinical settings, although there is limited evidence on SSI prevention, 1.5% OLG might be more effective than 10% PVP‐I and 1% CHG in preventing SSI. However, the clinical usefulness of OLG is unclear due to the limited number of clinical studies. Also, clinical research is limited to studies targeting SSI prevention, and there are no clinical studies on CRBSI. Further clinical studies are needed on SSI and CRBSI prevention.

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“…Several strategies, including sampling from various venipuncture sites, reliance on a well-trained phlebotomy staff, and the informational intervention and feedback, have been advocated to reduce rates of blood culture contamination 5 , 28 , 29 . Topical disinfection with olanexidine, which already is commercially available in Japan, also is expected to reduce the rate of blood culture contamination, given that this disinfectant recently was shown to exhibit stronger bactericidal activity than PVI for surgical site infection 30 .…”

Section: Discussionmentioning

confidence: 99%

Regression discontinuity of blood culture contamination rate after changing of disinfectants: retrospective observational study

Ota

Nishioka

Ito

et al. 2021

Sci Rep

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Blood cultures are indispensable for detecting life-threatening bacteremia. Little is known about associations between contamination rates and topical disinfectants for blood collection in adults. We sought to determine whether a change in topical disinfectants was associated with the rates of contaminated blood cultures in the emergency department of a single institution. This single-center, retrospective observational study of consecutive patients aged 20 years or older was conducted in the emergency department (ED) of a university hospital in Japan between August 1, 2018 and September 30, 2020. Pairs of blood samples were collected for aerobic and anaerobic culture from the patients in the ED. Physicians selected topical disinfectants according to their personal preference before September 1, 2019; alcohol/chlorhexidine gluconate (ACHX) was mandatory thereafter, unless the patient was allergic to alcohol. Regression discontinuity analysis was used to detect the effect of the mandatory usage of ACHX on rates of contaminated blood cultures. We collected 2141 blood culture samples from 1097 patients and found 164 (7.7%) potentially contaminated blood cultures. Among these, 445 (20.8%) were true bacteremia and 1532 (71.6%) were true negatives. Puncture site disinfection was performed with ACHX for 1345 (62.8%) cases and with povidone-iodine (PVI) for 767 (35.8%) cases. The regression discontinuity analysis showed that mandatory ACHX usage was significantly associated with lower rates of contaminated blood cultures by 9.6% (95% confidence interval (CI): 5.0%–14.2%, P < 0.001). Rates of contaminated blood cultures were significantly lower when ACHX was used as the topical disinfectant.

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Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial

Cited by 36 publications

References 23 publications

Clinical Study of The Novel Antiseptic Olanexidine Gluconate in Gastrointestinal Cancer Surgery

Clinical Study of The Novel Antiseptic Olanexidine Gluconate in Gastrointestinal Cancer Surgery

Clinical application of skin antisepsis using aqueous olanexidine: a scoping review

Regression discontinuity of blood culture contamination rate after changing of disinfectants: retrospective observational study

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