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NCT Number: NCT06302335

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Clinicas de Porto Alegre

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

Location status: Recruiting

Location contact

Daniel C Damin

CONTACT

[email protected]

+5551996020442

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povidone-Iodine

Drug

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

Saline Solution

Drug

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

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days

    Surgical site infection within 30 days from the surgical procedure

Secondary outcomes

  1. Intracavitary surgical infection

    Time frame: 30 days

    Infections within the abdominal cavity

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel C Damin, PhD

CONTACT

[email protected]

+5551996020442

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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