Phase 2 N=100 Randomized Single-blind Treatment

Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis

Acute, Perforated Appendicitis

Bottom Line

View on ClinicalTrials.gov: NCT02664220 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Number of Participants With Postoperative Intra-abdominal Abscess — 6; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Povidone-iodine irrigation (Drug); No irrigation (Procedure)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Postoperative Intra-abdominal Abscess	6; 8	—
SECONDARY Total Hospital Length of Stay	5.1; 6.1	—
SECONDARY Number of Participants Who Were Readmitted to the Hospital	0; 3	—
SECONDARY Number of Participants Who Visited the Emergency Room	3; 7	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02664220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.