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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post surgery
Awards & highlights
PAPPA 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.Check my eligibility
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.See study design
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.
PAPPA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had my appendix removed due to acute appendicitis.
PAPPA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients with post operative intra-abdominal abscesses
Secondary outcome measures
Length of hospital stay(LOS)
Number of patients that are readmitted
PAPPA 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
903 Previous Clinical Trials
319,227 Total Patients Enrolled
Kuojen Tsao, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with appendicitis.I have had my appendix removed, either planned or by chance.I had my appendix removed due to acute appendicitis.I have a history of iodine allergy, thyroid issues, or kidney problems.I tried treatments other than surgery for over 48 hours after my diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Irrigation with PVI
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility criteria for participating in this clinical trial?
"This medical trial is enrolling 1750 patients ranging in age from 2 to 17 who have been diagnosed with acute appendicitis. To be eligible, participants must have undergone an appendectomy and had their intraoperative diagnosis confirm perforation of the appendix."
Answered by AI
Are there any vacancies for this clinical experiment?
"The clinical trial's page on the website clinicaltrials.gov reveals that recruitment has ceased, as it was initially posted on December 1st 2022 and last modified May 17th 2022. Fortunately, there are 32 other trials presently seeking volunteers for their studies."
Answered by AI
How hazardous is irrigation with PVI to humans?
"Irrigation with PVI is an approved therapeutic intervention, which explains why it was given a safety rating of 3."
Answered by AI
Is the eligibility criteria for this trial including individuals over forty years of age?
"This clinical trial has specified that the minimum age of participants must be at least 2 years old and the maximum is 17."
Answered by AI
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