Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Dec 12, 2019

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ClinConnect Summary

This clinical trial is studying the use of a solution called povidone-iodine (PVI) to wash out the abdomen during surgery for children with a specific type of appendicitis known as perforated appendicitis. The goal is to see if using this solution can help reduce the number of patients who develop complications like intra-abdominal abscesses (which are pockets of infection) after surgery and to understand if it can also shorten their hospital stay and reduce the chances of needing to return to the hospital within 30 days.

To participate in this study, children aged 2 to 17 who are admitted to a participating hospital for surgery to remove their appendix may be eligible if they have been diagnosed with perforated appendicitis during their surgery. However, children with certain conditions—like simple appendicitis or those with allergies to iodine—won't be able to join. If a child is selected to take part, they can expect to receive either the PVI irrigation or the standard care during their surgery, and researchers will monitor their recovery for a month afterward to see how they do. This trial is still preparing to start, so no participants have been enrolled yet.

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Eligibility criteria

• Inclusion Criteria:
• • Admitted to a participating center
• • Appendectomy performed for acute appendicitis
• • Intraoperative diagnosis of perforated appendicitis
• Exclusion Criteria:
• • Simple or gangrenous appendicitis
• • Interval or incidental appendectomy
• • Initial attempt at non-operative management (defined as \>48 hours between the time of diagnosis and surgical intervention)
• • History of iodine allergy, thyroid disease or renal dysfunction
• • Pregnancy