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

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

712

347 were in the PI (povidone iodine) irrigation (syringe pressure washing with normal saline (NS) following 10% PI irrigation), and 350 were assigned to the control group (syringe pressure washing with NS) in the full-analysis set. The age and sex of each group were as follows: PI group: median age 68 (20-92), 209 males and 138 females; control group: median age 70 (20-92), 221 males and 129 females. Background factors did not differ between the two groups in terms of age, sex, smoking history, drinking history, ASA-PS (American Society of Anesthesiologists-Physical Status), BMI, diabetes, use of immunosuppressive drugs, and hypoalbuminemia. Surgical factors did not differ between the two groups for upper gastrointestinal surgery, lower gastrointestinal surgery, hepatobiliary/pancreatic surgery, emergency surgery, laparoscopic surgery, intraoperative blood loss, and wound classification.

Between November 9, 2020, and December 23, 2022, 894 patients were assessed for eligibility, where 712 patients were included, among which 358 were in the PI group and 354 were assigned to the control group. Fifteen patients who met exclusion criteria after randomization were excluded from the full-analysis set. Therefore, 347 were in the PI irrigation, and 350 were assigned to the control group in the full-analysis set.

No significant differences in the overall adverse effects were detected between the PI and the control groups. Erythema was found in three patients in the control group.

The primary outcome of overall 30-day SSI in the full-analysis set occurred in 54 (16%) participants from the PI group and 46 (13%) from the control group (OR, 1.229; 95% CI, 0.800-1.889; p = 0.406). For the secondary outcomes assessed in the full-analysis set, the PI group was significantly associated with a higher rate of superficial incisional SSI (30 (9%) vs. 15 (4%); OR, 2.154; 95% CI, 1.134-4.090; p = 0.026). Deep incisional SSI did not occur, and there were no significant differences in organ/space SSI (24 (7%) vs. 31 (9%); OR, 0.756; 95% CI, 0.431-1.326; p = 0.406).

In this randomized controlled trial including 697 patients, the povidone-iodine irrigation did not significantly reduce the incidence of 30-day surgical site infections, compared with saline irrigation. The importance of this report is that it provides povidone-iodine wound irrigation has no an additional beneficial effect on occurrence of SSI.

July. 12, 2024

June. 01, 2024

https://doi.org/10.1016/j.surg.2024.04.034

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1041200056

Takeuchi Hiroya

Hamamatsu University School of Medicine

1-20-1, Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan

takeuchi@hama-med.ac.jp

Takeda Makoto

Hamamatsu University School of Medicine

1-20-1, Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan

+81-53-435-2279

mtakeda@hama-med.ac.jp

Complete

Nov. 02, 2020

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

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.

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.

Both

Gastroentelogical surgery

Surgical wound antisepsis with povidone iodine before skin closure

Postoperative 30-day surgical site infection (SSI) rate

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.

+81-53-435-2680

Oct. 12, 2020

none