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Effects of olanexidine versus popidon-iodine with alcohol for surgical skin antisepsis on surgical site infection in gastroenterological surgery: A multicenter randomized controlled trial

Effects of olanexidine versus popidon-iodine with alcohol for surgical skin antisepsis on surgical site infection in gastroenterological surgery: A multicenter randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041240057
Enrollment
520
Registered
2024-07-20
Start date
2024-07-20
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

Efficacy of surgical skin antisepsis on the incidence of SSI for elective gastroentelogical surgery Gastroentelogical surgery

Interventions

Intervention group: Using Olanexidine Gluconate for surgical skin antisepsis Control group: Using Povidone-iodine with alcohol for surgical skin antisepsis

Sponsors

Takeuchi Hiroya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Intended for patients who meet all of the following criteria: 1. Patients who are over 18 years old when obtaining consent (regardless of gender) 2. Patients undergoing gastroentelogical elective surgery (such as surgery for esophagus, stomach, small intestine, large intestine, liver, biliary tract, or pancreas) meeting wound class 2. Excluded: inguinal hernia, hiatal hernia, colostomy, colostomy closure, abdominopelvic rectal resection. 3. Patients who have received sufficient explanation for participation in this study, and who have provided written consent.

Exclusion criteria

Exclusion criteria: Patients who violate any of the following will not be included in this study: 1) Patients who have allergy for popidone iodine. 2) Patients who have allergey for alcohol. 3) Patients who have allergey for olanexidine. 4) Patients who cannot be followed up for 30 days after surgery (e.g., scheduled for second-stage surgery for esophageal cancer, scheduled for another general anesthesia surgery within 30 days after surgery, return directly to the facility (referring hospital, clinic, nursing facility, etc.) after surgery). 5) Patients who hav active infection excluding viral hepatitis 6) Patients who are in pregnancy or may be pregnant. 7) Patients lactating. 8) Patients with sever thyroid dysfunction. 9) Any patients who judged to be inappropriate by the study investigators.

Design outcomes

Primary

MeasureTime frame
Postoperative 30-day surgical site infection (SSI) rate

Secondary

MeasureTime frame
Postoperative 30-day superficial incisional SSI rate,deep incisional SSI rate, organ/space SSI rate. Length of hospital stay. Costs of hospital stay. Postoperative 30-day rate of positive bacterial wound culture, and their strains, and toxicity and allergies events (erythema, symptoms of allergy) rate.

Contacts

Public ContactMakoto Takeda

Hamamatsu University School of Medicine

mtakeda@hama-med.ac.jp+81-53-435-2279

Outcome results

None listed

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