Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

2022-0442

Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.

2023-01-02

2027-12-31

2027-12-31

Recruiting

Early phase I

228

Inclusion Criteria: Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology. Exclusion Criteria: * age under 18; * surgery classified as dirty; * urgent/emergency surgery; * patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ); * known allergy to iodine.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participants will not know what kind of substance will be used during the surgery.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 228, 'type': 'ESTIMATED'}}

2024-03-08