APPI-Cost Trial for Perforated Appendicitis

PHASE4RecruitingINTERVENTIONAL
Enrollment

346

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

March 31, 2027

Conditions
Perforated Appendicitis
Interventions
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.

Trial Locations (1)

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER