Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
ConditionSurgical Site Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 80 years of age
undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds
Disqualifiers
Pregnancy
Preoperative abdominal wall skin/soft tissue infection
Iodine allergy
Patients unlikely to survive beyond 30 days
Trial design
Design model
Parallel
Treatments tested in this trial
Povidone-Iodine
DrugPeritoneal 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.
Normal Saline
DrugPeritoneal 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.
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound IrrigationExperimental treatment 1 intervention
Group B: Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound IrrigationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Surgical Site Infection
Subjects in each study arm will be assessed for presence of surgical site infection using a composite measurement based on the CDC/NHSN Guidelines for Surgical Site Infection (SSI) Event (January 2024). The presence of one or more of the following will constitute a surgical site infection: 1. purulent drainage from the superficial incision, deep incision or the drain in an organ/space 2. organism(s) identified from an aseptically-obtained specimen from the superficial incision, subcutaneous tissue, deep soft tissues, or fluid or tissue in the organ space by a culture or nonculture based microbiologic testing method 3. an incision that is deliberately opened by a provider AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat 4. an abscess or other evidence of infection involving the deep incision or organ/space detected on gross anatomical exam, histopathologic exam, or imaging test
Time frame
Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively)Secondary outcomes
1
Readmission
Subjects in each study arm will be assessed for the number of times the subject has been readmitted into the hospital for any cause. This will be tracked by chart review and follow-up until 30 days after the initial operation.
Time frame
Between date of surgery and 30 days post-operatively2
Return to the Operating Room
Subjects in each study arm will be assessed for the number of times the subject returns to the operating room for any cause. This will be tracked throughout the hospital stay and post-discharge by chart review and follow-up until 30 days after the initial operation.
Time frame
Between date of surgery and 30 days post-operatively3
Ileus
Subjects in each study arm will be assessed for the development of an ileus. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with no transition point identified.
Time frame
Between date of surgery and 30 days post-operatively4
Small Bowel Obstruction
Subjects in each study arm will be assessed for the development of a small bowel obstruction. This will be diagnosed by lack of bowel function, physical examination (i.e. abdominal distention, tympany) and KUB x-ray to assess for distended loops of bowel with a transition point identified. Additional testing including an upper gastrointestinal series (e.g. small bowel follow through) can be used in a case-by-case if medically necessary for diagnosis.
Time frame
Between date of surgery and 30 days post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov