Phase 2
Completed N=100
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Acute, Perforated Appendicitis
Source: ClinicalTrials.gov NCT02664220 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Postoperative Intra-abdominal Abscess — 6; 8 Participants
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.
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 | — |
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
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. Informational only — not medical advice.