APPI-Cost Trial for Perforated Appendicitis

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Perforated Appendicitis

Treatments: Drug: PVI; Drug: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06705842

HSC-MS-24-0772

1K12TR004908-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 346 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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346 participants in 2 patient groups

PVI

Active Comparator group

Treatment:

Drug: PVI

Usual Care

Active Comparator group

Treatment:

Drug: Usual Care