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

JRCT ID: jRCT1041240057

Registered date:20/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Efficacy of surgical skin antisepsis on the incidence of SSI for elective gastroentelogical surgery
• Date of first enrollment: 20/07/2024
• Target sample size: 520
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Postoperative 30-day surgical site infection (SSI) rate

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takeuchi Hiroya