Recruiting PHASE3 Surgical Site Infection

Compares treatment options for Surgical Site Infection

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

ClinicalTrials.gov ID: NCT06363877

What this study is testing

What is Povidone-Iodine?

Povidone-Iodine is an investigational medicine, being studied as a potential treatment for surgical site infection.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Time commitment: about 18 months
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Loma Linda, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.