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

NCT06302335 | Recruiting Phase 3 DMC

• 1 other identifier: 2022-0442
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Site Infection

Keywords

surgical site infection; colorectal surgey

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infection within 30 days from the surgical procedure

  30 days

Secondary Outcomes (1)

• Intracavitary surgical infection

  30 days

Study Arms (2)

Povidone-iodine arm

EXPERIMENTAL

Patients submitted to colorectal resections using Povidone-iodine in the surgical wound.

Drug: Povidone-iodine

Saline solution arm.

ACTIVE COMPARATOR

Patients submitted to colorectal resections using saline solution in the surgical wound.

Drug: Saline solution

Interventions

Povidone-iodine DRUG

Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.

Povidone-iodine arm

Saline solution DRUG

Application of saline solution to the surgical wound of patients submitted to colorectal resections.

Saline solution arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; Saline Solution

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Daniel C Damin, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Damin, PhD

CONTACT

+5551996020442; damin@terra.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know what kind of substance will be used during the surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: January 2, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

BR (1)