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

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Loma Linda University (LLU)

Status and phase

Not yet enrolling
Phase 3

Conditions

Surgical Site Infection

Treatments

Drug: Normal Saline
Drug: Povidone-Iodine

Study type

Interventional

Funder types

Other

Identifiers

NCT06363877
5220078

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,100 participants in 2 patient groups

Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation
Experimental group
Description:
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution.
Treatment:
Drug: Povidone-Iodine
Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation
Active Comparator group
Description:
Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution.
Treatment:
Drug: Normal Saline

Trial contacts and locations

1

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Central trial contact

Martin G Rosenthal, MD; Mohamed H El-Farra, MD

Data sourced from clinicaltrials.gov

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