Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
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About
The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal irrigation.
Full description
Postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis in pediatric patients despite utilization of evidence-based practices. Povidone-iodine is a commonly used antiseptic in surgical procedures and has been shown to be effective in reducing postoperative abscesses in adults with perforated appendicitis. This trial will be the first to rigorously test the efficacy of povidone-iodine irrigation in children and to verify its safety profile in this patient population.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)
Exclusion criteria
- Patients presenting with simple or gangrenous appendicitis
- Patients with a history of iodine sensitivity, thyroid disease or renal disease
- Patients undergoing interval or incidental appendectomy
- Patients/parents/legal guardians who are both non-English and non-Spanish speaking
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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