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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participants will not know what kind of substance will be used during the surgery.

Study Groups

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Povidone-iodine arm

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

Group Type EXPERIMENTAL

Povidone-iodine

Intervention Type DRUG

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

Saline solution arm.

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

Group Type ACTIVE_COMPARATOR

Saline solution

Intervention Type DRUG

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

Interventions

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Povidone-iodine

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

Intervention Type DRUG

Saline solution

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No