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

NCT04200729 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1750

Last updated 2025-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Acute, Perforated Appendicitis

Interventions

DRUG

Irrigation with PVI

The intervention will be irrigation with PVI, diluted to a concentration of 1% (containing 0.1% active iodine). After removal of the appendix from the patient's abdomen and attainment of hemostasis,10 mL/kg of 1% PVI solution 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.

PROCEDURE

Usual care

The control will be usual care, which is expected to vary between institutions. The only stipulation for usual care will be that surgeons do not change their usual practice during the baseline period. Some surgeons utilize intra-abdominal irrigation while others use only local irrigation. Intraabdominal irrigation is defined as intraoperative instillation of a large volume (\> 200 mL) of irrigation solution into all 4 quadrants of the abdomen. Local irrigation is defined as instillation of a small volume of liquid, typically \<50 mL, in the operative field. Intra-abdominal irrigation is utilized with the intention of preventing IAAs while local irrigation is often used to confirm hemostasis or assist with suctioning thick purulent fluid.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Kuojen Tsao, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2030-03-01
Completion
2030-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200729 on ClinicalTrials.gov