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

Phase 2

Completed

• Conditions: Acute, Perforated Appendicitis
• Interventions: Drug: Povidone-iodine irrigation; Procedure: No irrigation

• Registration Number: NCT02664220
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Study Start: 2016-04
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-03
• Results First Submitted: 2019-03-06
• Results First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Results First Posted: 2019-04-17
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Povidone-iodine irrigation	Povidone-iodine irrigation	-
No irrigation	No irrigation	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Intra-abdominal Abscess	30 days post surgery	30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol

Secondary Outcome Measures

Name	Time	Method
Total Hospital Length of Stay	30 days post surgery	Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.
Number of Participants Who Were Readmitted to the Hospital	30 days post surgery	Whether or not a patient was readmitted to the hospital within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
Number of Participants Who Visited the Emergency Room	30 days post surgery	Whether or not a patient visited the emergency room for care directly related to the operation within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States