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

Randomized controlled trial of surgical wounds antisepsis with aqueous povidone-iodine for prophylaxis of surgical site infection in gastroenterological surgery. - SURPRISE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041200056
Enrollment
700
Registered
2020-10-28
Start date
2020-11-02
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

Gastroentelogical surgery

Interventions

Surgical wound antisepsis with povidone iodine before skin closure

Sponsors

Takeuchi Hiroya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

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) 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.

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. 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.

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