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A randomized trial of efficacy of Olanexidine gluconate versus Chlorhexidine Gluconate for preventing surgical site infection - Phase II clinical trial -

A randomized trial of efficacy of Olanexidine gluconate versus Chlorhexidine Gluconate for preventing surgical site infection - Phase II clinical trial - - A randomized trial of efficacy of Olanexidine gluconate for preventing surgical site infection

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048691
Enrollment
200
Registered
2022-09-01
Start date
2022-08-09
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

Cardiovascular surgery, Digestive surgery

Interventions

Use of 1.5% Olanexidine gluconate for surgical site before surgery Use of 1.0% Chlorhexidine gluconate for surgical site before surgery

Sponsors

Iwaki city medical center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients that satisfy all of the below requirements. 1)Surgery for cardiovascular surgery with sternotomy, or gastrointestinal surgery with laparotomy additionally wound classification class II or less. 2)The age is older than 18 years of age. 3)Having provided voluntary written consent for participation in this study.

Exclusion criteria

Exclusion criteria: Patients with any of the following cases are excluded. 1)Patients contraindicated for Olanexidine glucose or Chlorhexidine Gluconate 2)Follow- up failure due to pass-away or other reasons. 3)In case of urgent operation 4)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 rate

Countries

Japan

Contacts

Public ContactYoshiki Endo

Iwaki city medical center Department of cardiovascular surgery

yoshiki_endo@hotmail.com0246-26-3151

Outcome results

None listed

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