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Antiseptic

Povidone-Iodine Irrigation for Appendicitis (PAPPA Trial)

Phase 4
Waitlist Available
Led By Kuojen Tsao, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Appendectomy performed for acute appendicitis
Be younger than 18 years old
Must not have
Simple or gangrenous appendicitis
Interval or incidental appendectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the rate of postoperative intra-abdominal abscesses and hospital length of stay for patients who receive povidone-iodine irrigation versus usual care.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from PVI irrigation may include allergic reactions in those sensitive to iodine and potential effects on thyroid function or kidneys due to iodine absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had my appendix removed due to acute appendicitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with appendicitis.
Select...
I have had my appendix removed, either planned or by chance.
Select...
I have a history of iodine allergy, thyroid issues, or kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
number of patients with post operative intra-abdominal abscesses
Secondary study objectives
Length of hospital stay(LOS)
Number of patients that are readmitted

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Irrigation with PVIExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
947 Previous Clinical Trials
343,239 Total Patients Enrolled
Kuojen Tsao, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Povidone-iodine (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT04200729 — Phase 4
Acute Appendicitis Research Study Groups: Usual care, Irrigation with PVI
Acute Appendicitis Clinical Trial 2023: Povidone-iodine Highlights & Side Effects. Trial Name: NCT04200729 — Phase 4
Povidone-iodine (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04200729 — Phase 4
~913 spots leftby Nov 2025
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