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

Acute, Perforated Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664220
• Other study ID #: HSC-MS-15-1000
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute, Perforated Appendicitis
• Appendicitis

Intervention

Drug:
• Povidone-iodine irrigation
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.

Procedure:
• No irrigation
Patients allocated to the control group will not undergo intra-abdominal irrigation.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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