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Recruiting NCT06363877

Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

Phase III Interventional Surgical Site Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Povidone-Iodine, Normal Saline.
Who it may be relevant to
Registry conditions: Surgical Site Infection. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

Overview

This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds.

Detailed description

The main objective is stated in the Brief Summary. The secondary objective is to determine the safety and adverse events of povidone-iodine compared to normal saline for irrigation in patients undergoing emergency laparotomies for CDC class 2 and 3 wounds.

The main questions this study aims to answer are:

* Does combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine decrease surgical site infections? * Is combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine safe to use compared to normal saline? * Are there any adverse effects of combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine usage on CDC class 2 and 3 wounds compared to normal saline?

Subjects will be followed over 18 months with follow-up of each patient up to 30 days postoperatively. Randomization of patients will occur prior to going to beginning the emergency laparotomy.

Interventions

  • Drug Povidone-Iodine
    Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of dilute aqueous povidone-iodine solution allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the povidone-iodine solution then wash-out with 2L of normal saline followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL povidone-iodine solution, suctioned, then washed-out with 500 mL normal saline.
  • Drug Normal Saline
    Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of normal saline allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the solution, wash-out with 2L of normal saline, followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL normal saline solution, suctioned, then washed-out with 500 mL normal saline.

Primary outcome measures

  • Surgical Site Infection [Time frame: Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)]
Secondary outcome measures (4)
  • Readmission [Time frame: Between date of surgery and 30 days post-operatively]
  • Return to the Operating Room [Time frame: Between date of surgery and 30 days post-operatively]
  • Ileus [Time frame: Between date of surgery and 30 days post-operatively]
  • Small Bowel Obstruction [Time frame: Between date of surgery and 30 days post-operatively]

Eligibility criteria

Inclusion criteria

  • 18 to 80 years of age
  • undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds

Exclusion criteria

  • Pregnancy
  • Preoperative abdominal wall skin/soft tissue infection
  • Iodine allergy
  • Patients unlikely to survive beyond 30 days
  • Patients with mesh placement or placement of a foreign body except for drains

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Loma Linda University Health — Loma Linda

Identifiers

NCT: NCT06363877 · 5220078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗