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Aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on the incidence of surgical site infections

Aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on the incidence of surgical site infections - Oedo trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049712
Enrollment
700
Registered
2022-12-07
Start date
2023-01-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical site infection

Interventions

1.5% oranexidine gluconate disinfection group 1% Chlorhexidine gluconate alcohol antiseptic

Sponsors

Keio University School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing standby general anesthesia surgery in the field of digestive organs (esophagus, stomach, duodenum, small intestine, colon, liver, biliary tract, pancreas) with wound classification Class II 2) Patients must be at least 18 years of age at the time of obtaining research consent. 3) Written consent to participate in the study has been obtained from the patient

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy to alcohol, including oranexidine gluconate or chlorhexidine gluconate alcohol 2) Patients who cannot be followed up for 30 days after surgery 3) Patients with active infection (except viral hepatitis) 4) Patients who have received antimicrobial agents the day before surgery 5) Emergency surgery and surgery requiring disinfection of mucous membrane surfaces and wound sites 6) Patients with a history of asthma 7) Other patients deemed by the physician to be unsuitable for the safe conduct of this study

Design outcomes

Primary

MeasureTime frame
Postoperative 30-day surgical site infection rate

Secondary

MeasureTime frame
postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, positive bacterial wound culture rate, bacterial strain, intervention-related toxicity and allergic events rates, reoperation rate due to SSI, medical economic effect indicator, hospitalization duration.

Countries

Japan

Contacts

Public ContactMasashi Takeuchi

Keio University School of Medicine Department of Surgery

masaty871222@gmail.com03-5363-3802

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026