Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Povidone-iodine; Drug: Saline solution

Detailed Description

Patients will be randomized to one of the following intervention groups:

Group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues.

NOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team.

Randomization: the block randomization method will be used (blocks of 4 patients each).

Groups 1 and 2 will be compared with each other regarding the outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daniel C Damin, PhD; Phone Number: +5551996020442; Email: damin@terra.com.br

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90.035-903
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Daniel C Damin; Phone Number: +5551996020442; Email: damin@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povidone-iodine arm; Patients submitted to colorectal resections using Povidone-iodine in the surgical wound.	Drug: Povidone-iodine; Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.
Active Comparator: Saline solution arm.; Patients submitted to colorectal resections using saline solution in the surgical wound.	Drug: Saline solution; Application of saline solution to the surgical wound of patients submitted to colorectal resections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Surgical site infection within 30 days from the surgical procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracavitary surgical infection	Infections within the abdominal cavity	30 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Daniel C Damin, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: surgical site infection; colorectal surgey
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 2022-0442

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No