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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-Iodine Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation | Experimental | Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a diluted aqueous povidone-iodine solution. |
|
| Normal Saline Intraoperative Peritoneal Lavage and Intraoperative Wound Irrigation | Active Comparator | Patients in this arm will undergo combined intraoperative peritoneal lavage and intraoperative wound irrigation with a normal saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Between date of initial operation and post-operative follow up visit (up to 30 days post-operatively) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between date of surgery and 30 days post-operatively |
| Return to the Operating Room |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin G Rosenthal, MD | Contact | 909-558-4000 | mrosenthal@ll.edu | |
| Mohamed H El-Farra, MD | Contact | melfarra@llu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Recruiting | Loma Linda | California | 92354 | United States |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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|
| Normal Saline | Drug | 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. |
|
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. |
| Between date of surgery and 30 days post-operatively |
| 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. | Between date of surgery and 30 days post-operatively |
| 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. | Between date of surgery and 30 days post-operatively |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |