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

Study acronym: PAPPA
StatusNot Yet Recruiting
PhasePhase 4
Started2027-03-01
View on ClinicalTrials.gov ↗

Amendment history

2025-02-06
Study Identification, Study Status, Oversight, Contacts/Locations v6
Primary completion date2024-05-01→2030-03-01
Completion date2024-05-01→2030-03-01
Start date2023-12-01→2027-03-01
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: Aa Multi-center Stepped Wedge Cluster Randomized Study
2023-05-22
Study Status v5
Start date2022-12-01→2023-12-01
2022-05-17
Study Status v4
Start date2021-12-01→2022-12-01
2021-09-29
Study Status v3
Start date2021-06-01→2021-12-01
2021-04-11
Study Status v2
Primary completion date2022-03-01→2024-05-01
Completion date2022-03-01→2024-05-01
Start date2020-07-01→2021-06-01
2019-12-13
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2019-12-12
Original filing
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.
Trial Details
NCT Number NCT04200729
Lead Sponsor The University of Texas Health Science Center, Houston
Conditions Acute, Perforated Appendicitis
Enrollment 1,750 participants
Start Date 2027-03-01
Primary Completion 2030-03-01 (estimated)
Study Completion 2030-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-10