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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Pilot Trial of Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis

Conditions
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Acute, Perforated Appendicitis

Intervention / Treatment
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* Drug: Povidone-iodine irrigation
* Procedure: No irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone-iodine irrigation<br> | Drug: Povidone-iodine irrigation<br>* Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis. 1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.<br>|
| Active Comparator: No irrigation<br> | Procedure: No irrigation<br>* Patients allocated to the control group will not undergo intra-abdominal irrigation.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Hospital Length of Stay | Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days. | 30 days post surgery | 
| Number of Participants Who Were Readmitted to the Hospital | 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. | 30 days post surgery | 
| Number of Participants Who Visited the Emergency Room | 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. | 30 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Povidone-iodine irrigation