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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Iodine; Povidone; Povidone-Iodine

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