NCT06705842

APPI-Cost Trial for Perforated Appendicitis

The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perforated Appendicitis

Interventions

Type	Name	Description
DRUG	PVI	After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL/kg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out
DRUG	Usual Care	Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (\<100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-06-30
• Completion: 2027-03-31
• First posted: 2024-11-26
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study