Povidone-Iodine Irrigation for Appendicitis (PAPPA Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByKuojen Tsao, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children with a confirmed diagnosis of perforated appendicitis who are undergoing an appendectomy at a participating center. It's not for those who tried non-surgical treatment first, have simple or gangrenous appendicitis, are pregnant, or have iodine allergy, thyroid issues, or kidney problems.

Inclusion Criteria

I had my appendix removed due to acute appendicitis.

Exclusion Criteria

I have been diagnosed with appendicitis.

I have had my appendix removed, either planned or by chance.

I have a history of iodine allergy, thyroid issues, or kidney problems.

Participant Groups

The study is testing if washing out the inside of the abdomen with povidone-iodine (PVI) during surgery can reduce abscesses after operation compared to usual care. The impact on hospital stay and readmissions within 30 days post-surgery will also be evaluated.

2Treatment groups

Experimental Treatment

Active Control

Group I: Irrigation with PVIExperimental Treatment1 Intervention

Group II: Usual careActive Control1 Intervention