NCT06705842PHASE4Recruiting
APPI-Cost Trial for Perforated Appendicitis
The University of Texas Health Science Center, Houston
Start Date
4/7/2025
Completion Date
3/31/2027
Summary
The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.
Eligibility Criteria
Age Range: 18 years to No maximum
Eligibility for Enrollment
Inclusion Criteria:
* Plan to undergo appendectomy for acute appendicitis
Exclusion Criteria:
* Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
* Allergy to iodine
* Uncontrolled hyper- or hypothyroidism
* Renal dysfunction
* Pregnant or breastfeeding
* Primary language neither English nor Spanish
* Lack of functioning telephone or email account
* Incarcerated or in police custody
Eligibility for Randomization
Inclusion Criteria:
* Enrolled in study preoperatively
* Intraoperative diagnosis of perforated appendicitis
Exclusion Criteria:
* Non-perforated appendicitis
Interventions
DRUG
PVI
DRUG
Usual Care
Conditions
Perforated Appendicitis
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States