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Recruiting Phase 4 NCT06705842

APPI-Cost Trial for Perforated Appendicitis

Trial Parameters

Condition Perforated Appendicitis
Sponsor The University of Texas Health Science Center, Houston
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 346
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-07
Completion 2026-06-30
Interventions
PVIUsual Care

Brief 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

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

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