Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study (PAPPA)

The University of Texas System (UT)

Status and phase: Begins enrollment in a year or more; Phase 4

Conditions: Acute, Perforated Appendicitis

Treatments: Drug: Irrigation with PVI; Procedure: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04200729

HSC-MS-19-0810

Details and patient eligibility

About

The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.

Enrollment: 1,750 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to a participating center
• Appendectomy performed for acute appendicitis
• Intraoperative diagnosis of perforated appendicitis

Exclusion criteria

• Simple or gangrenous appendicitis
• Interval or incidental appendectomy
• Initial attempt at non-operative management (defined as >48 hours between the time of diagnosis and surgical intervention)
• History of iodine allergy, thyroid disease or renal dysfunction
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,750 participants in 2 patient groups

Irrigation with PVI

Experimental group

Treatment:

Drug: Irrigation with PVI

Usual care

Active Comparator group

Treatment:

Procedure: Usual care