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NCT04200729 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.

Not yet
Registry status
Phase 4
Development phase
1,750
Enrollment target

NCT04200729: Clinical Trial Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.

NCT04200729 is a Phase 4 study that has not yet begun recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 1,750 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (238% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04200729, a Phase 4 study, has not yet begun recruiting, sponsored by The University of Texas Health Science Center, Houston.

NOT YET RECRUITING
Registry status
Phase 4
Development phase
1,750 participants
Enrollment target

Study 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.

Primary Outcome

An IAA will be defined as: an image-confirmed (ultrasound, CT, or MRI) fluid collection deemed to be an IAA by an attending radiologist or pediatric surgeon, or an abscess confirmed during percutaneous intervention (aspiration of purulent fluid) or reoperation (direct visualization of purulent fluid).

Interventions

  • PROCEDURE Usual care
  • DRUG Irrigation with PVI

Trial Details

FieldValue
Enrollment Target 1,750 participants
Start Date 2027-03-01
Est. Completion 2030-03-01
Phase Phase 4

What is known before NCT04200729 opens enrollment

NCT04200729 is an interventional study that assigns participants to a tested intervention. Its 1,750 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (238% higher).

The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.

NCT04200729 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04200729 about?

NCT04200729 is a clinical study titled "Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study". 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) a...

What is the current status of trial NCT04200729?

This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 1,750 participants. The study started on 2027-03-01. Estimated completion is 2030-03-01.

What interventions are being tested in trial NCT04200729?

The interventions under investigation include: Usual care (PROCEDURE), Irrigation with PVI (DRUG).

Who is sponsoring clinical trial NCT04200729?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04200729's enrollment target sits among peer trials

1,750 45th of 2000 higher than 1,956 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04200729, the US trial registry maintained by the National Library of Medicine. NCT04200729 (large enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.