Randomized controlled trial of surgical wounds antisepsis with aqueous povidone-iodine.

JRCT ID: jRCT1041200056

Registered date:28/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastroentelogical surgery
• Date of first enrollment: 02/11/2020
• Target sample size: 700
• Study type: Interventional
• Intervention(s): Surgical wound antisepsis with povidone iodine before skin closure

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.
Postoperative 30- day SSI rate between urgent and elective surgery, among wound classes, between laparascopic or thoracoscopic and open surgery.
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: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Intended for patients who meet all of the following criteria:
1. Patients who are over 20 years old when obtaining consent (regardless of gender)
2. Patients undergoing gastroentelogical surgery (such as surgery for esophagus, stomach, small intestine, large intestine, liver, biliary tract, or pancreas) meeting wound class 2, 3, 4) .
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) follow-up failure due to pass away or other reasons
3) Patients who hav active infection excluding viral hepatitis
4) Patients who are in pregnancy or may be pregnant.
5) Patients lactating.
6) Patients with sever thyroid dysfunction.
7) Any patients who judged to be inappropriate by the study investigators.

Related Information

• Primary Sponsor: Takeuchi Hiroya