Disinfection with single or double usage of new antiseptic olanexidine gluconate in general surgery: a randomized study.

Abstract

PURPOSE:

Olanexidine gluconate is a newly developed solution for skin disinfection that was recently approved in Japan. We aimed to compare single and double application of the solution in preventing surgical site infection (SSI) in patients undergoing general surgery.

METHODS:

This randomized study was conducted at the Tottori University Hospital. Patients scheduled to undergo gastrointestinal or hernia surgery were randomly assigned to one of two groups using either one or two Olanedine applicators for skin disinfection. The primary endpoint was the difference in SSI incidence between the two groups. The secondary endpoint was all adverse events related to olanexidine gluconate.

RESULTS:

A total of 393 patients qualified for the study protocol: 193 received a single application, and 200 received a double application of Olanedine. SSI occurred in 10 patients (2.5%) overall; nine were superficial incisional SSIs, and one patient had a deep incisional SSI. Of the 10 patients who developed SSI, six (3.1%) were in the group receiving a single application, and four (2.0%) were in the group receiving a double application; there was no statistically significant difference between the two groups (P = 0.537). Allergic reactions or skin disorders related to olanexidine gluconate were not observed.

CONCLUSION:

There was no difference in the SSI incidence between the use of one or two Olanedine applicators for skin preparation in elective general surgery. Therefore, a single application of Olanedine is sufficient and is recommended for general surgery as a standard disinfection precaution.

TRIAL REGISTRATION NUMBER:

UMIN000027319; 5/12/2017.

• Authors: Manabu Yamamoto, Kazushi Hara, Ken Sugezawa, Chihiro Uejima, Akimitsu Tanio, Yoichiro Tada, Yuji Shishido, Kozo Miyatani, Takehiko Hanaki, Kyoichi Kihara, Tomoyuki Matsunaga, Naruo Tokuyasu, Shuichi Takano, Teruhisa Sakamoto, Soichiro Honjo, Yoshiyuki Fujiwara
• Journal: Langenbeck's archives of surgery (Langenbecks Arch Surg) Vol. 405 Issue 8 Pg. 1183-1189 (Dec 2020) ISSN: 1435-2451 [Electronic] Germany
• PMID: 33057823 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Infective Agents, Local
• Biguanides
• Glucuronates
• Povidone-Iodine
• olanexidine gluconate

Topics

• Anti-Infective Agents, Local (adverse effects)
• Biguanides
• Disinfection
• Glucuronates
• Humans
• Povidone-Iodine
• Surgical Wound Infection (prevention & control)