Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation

NAActive, not recruitingINTERVENTIONAL
Enrollment

2,500

Participants

Timeline

Start Date

August 2, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Surgical Site Infection
Interventions
PROCEDURE

Intraoperative incisional wound irrigation with povidone-iodine solution

Participants randomized to the povidone-iodine irrigation group will have all incisions irrigated once with povidone-iodine diluted in 0.9% sterile normal saline (to a final concentration of 5% povidone-iodine (0.5% available iodine)) delivered through a bulb syringe. The povidone-iodine irrigation should be left on for 60 seconds and then dried with sterile gauze. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.

PROCEDURE

Intraoperative incisional wound irrigation with saline

Participants randomized to the saline irrigation group will have all incisions irrigated once with 0.9% sterile normal saline delivered through a bulb syringe. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.

Trial Locations (13)

R3A 1R9

Shared Health Manitoba, Winnipeg

Unknown

Royal Victoria Regional Health Centre, Barrie

Hamilton Health Sciences - Juravinski Hospital, Hamilton

Kingston Health Sciences Centre, Kingston

London Health Sciences Centre, London

Mackenzie Health, Richmond Hill

Thunder Bay Regional Health Sciences Centre, Thunder Bay

St. Joseph's Health Centre, Toronto

St. Michael's Hospital, Toronto

P3E 5J1

Health Sciences North, Greater Sudbury

M2K 1E1

North York General Hospital, North York

K1H 8L6

The Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER

NCT04548661 - Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation | Biotech Hunter | Biotech Hunter