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A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection

A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection - A randomized trial of efficacy of Olanexidine gluconate for surgical site infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031560
Enrollment
600
Registered
2018-03-05
Start date
2018-05-01
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

Gastrointestinal surgery

Interventions

use of Olanexidine gluconate for surgical site before surgery use of Povidone iodine for surgical site before surgery

Sponsors

Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients that satisfy all of the below requirements. 1) Surgery for gastrointestinal, such as gastrectomy, esophagectomy, hepatectomy and pancreaticoduodenectomy with wound classification classII 2)The age is older than 20 years of age. 3) Having provided voluntary written consent for participation in this study.

Exclusion criteria

Exclusion criteria: 1)Patients contraindicated for Olanexidine gluconate or Povidone iodine 2) Follow-up failure due to pass-away or other reasons. 3) Patients who have active infectious disease. 4)Patients who were prescribed antibiotics day before surgery. 5)Urgent surgery or surgery with sterilization to the mucosal surface or wound. 6)Patients judged by investigators ineligible due to seriousness of patients condition.

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, rate of positive bacterial wound culture, and their strains, and toxicity and allergies events (erythema, symptoms of allergy) rate.

Countries

Japan

Contacts

Public ContactMasashi Takeuchi

Keio University, School of Medicine Department of Surgery

masaty871222@gmail.com0353633802

Outcome results

None listed

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