Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: A Multi-center Stepped Wedge Cluster Randomized Study (PAPPA)

Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis

The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute, Perforated Appendicitis
• Intervention / Treatment: Drug: Irrigation with PVI; Procedure: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 1750
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kuojen Tsao, MD; Phone Number: (713) 500-7327; Email: KuoJen.Tsao@uth.tmc.edu
• Study Contact Backup: Name: Elisa Garcia; Phone Number: (713) 500-7434; Email: Elisa.I.Garcia@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Elisa Garcia; Phone Number: (713) 500-7434; Email: Elisa.I.Garcia@uth.tmc.edu
      • Contact: Kuojen Tsao, MD; Phone Number: 713-500-7327; Email: KuoJen.Tsao@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted to a participating center
• Appendectomy performed for acute appendicitis
• Intraoperative diagnosis of perforated appendicitis

Exclusion Criteria:

• Simple or gangrenous appendicitis
• Interval or incidental appendectomy
• Initial attempt at non-operative management (defined as >48 hours between the time of diagnosis and surgical intervention)
• History of iodine allergy, thyroid disease or renal dysfunction
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Procedure: Usual care; The control will be usual care, which is expected to vary between institutions. The only stipulation for usual care will be that surgeons do not change their usual practice during the baseline period. Some surgeons utilize intra-abdominal irrigation while others use only local irrigation. Intraabdominal irrigation is defined as intraoperative instillation of a large volume (> 200 mL) of irrigation solution into all 4 quadrants of the abdomen. Local irrigation is defined as instillation of a small volume of liquid, typically <50 mL, in the operative field. Intra-abdominal irrigation is utilized with the intention of preventing IAAs while local irrigation is often used to confirm hemostasis or assist with suctioning thick purulent fluid.
Experimental: Irrigation with PVI	Drug: Irrigation with PVI; The intervention will be irrigation with PVI, diluted to a concentration of 1% (containing 0.1% active iodine). After removal of the appendix from the patient's abdomen and attainment of hemostasis,10 mL/kg of 1% PVI solution will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with post operative intra-abdominal abscesses	An IAA will be defined as: an image-confirmed (ultrasound, CT, or MRI) fluid collection deemed to be an IAA by an attending radiologist or pediatric surgeon, or an abscess confirmed during percutaneous intervention (aspiration of purulent fluid) or reoperation (direct visualization of purulent fluid).	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay(LOS)	Total 30-day LOS will be defined as the aggregate of all days during which the patient is admitted to the hospital,including any related readmissions, within 30 postoperative days.	30 days post surgery
Number of patients that are readmitted	Readmissions will be considered to be related to the index encounter if they are due to abdominal pain, gastrointestinal symptoms, wound related concerns (such as superficial or deep surgical site infection or wound dehiscence), or infection of any kind (such as urinary tract infection, respiratory infection, or symptoms of infection, including fever).	30 days post surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Kuojen Tsao, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Suppuration; Cecal Diseases; Intraabdominal Infections; Abscess; Appendicitis; Abdominal Abscess
• Other Study ID Numbers: HSC-MS-19-0810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No