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Antiseptic
Povidone-Iodine Irrigation for Appendicitis
Phase 4
Waitlist Available
Led By Dalya Ferguson, MD, MS
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
Plan to undergo appendectomy for acute appendicitis
Be older than 18 years old
Must not have
Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
Uncontrolled hyper- or hypothyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 90 days, 6 months, and 12 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see if using povidone-iodine (PVI) solution during surgery for a burst appendix is helpful and cost-effective. They also want to understand what might make it easier
Who is the study for?
This trial is for individuals with acute appendicitis, particularly those who have a perforated appendix or an intra-abdominal abscess. The study aims to include patients who can provide informed consent and are eligible based on specific health criteria not detailed here.
What is being tested?
The APPI-Cost Trial is testing the effectiveness of povidone-iodine (PVI) irrigation compared to usual care in treating perforated appendicitis. It also examines cost-effectiveness, implementation barriers and facilitators, and collects various outcomes data.
What are the potential side effects?
Possible side effects may include irritation or allergic reaction at the site of PVI application, thyroid function changes due to iodine absorption, or general complications related to surgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for an appendectomy due to acute appendicitis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need drugs to maintain my blood pressure before surgery.
Select...
My thyroid condition is not under control.
Select...
I have kidney problems.
Select...
English or Spanish is not my first language.
Select...
I do not have a working phone or email.
Select...
My appendicitis did not cause my appendix to burst.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days, 90 days, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 90 days, 6 months, and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cost-effectiveness of PVI relative to usual care
Secondary study objectives
Health-related quality of life as assessed by the EQ-5D-5L questionnaire
Postoperative complications
Total patient-reported costs
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
Active Control
Group I: PVIActive Control1 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
957 Previous Clinical Trials
347,710 Total Patients Enrolled
2 Trials studying Appendicitis
1,850 Patients Enrolled for Appendicitis
National Center for Advancing Translational Sciences (NCATS)NIH
374 Previous Clinical Trials
408,936 Total Patients Enrolled
Dalya Ferguson, MD, MSPrincipal InvestigatorThe University of Texas Health Science Center, Houston