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

Phase 4

Not yet recruiting

• Conditions: Acute, Perforated Appendicitis
• Interventions: Procedure: Usual care; Drug: Irrigation with PVI

• Registration Number: NCT04200729
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Study Start: 2027-03-01
• Primary Completion: 2030-03-01
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1750

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	-
Irrigation with PVI	Irrigation with PVI	-

Primary Outcome Measures

Name	Time	Method
number of patients with post operative intra-abdominal abscesses	30 days post surgery	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).

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay(LOS)	30 days post surgery	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.
Number of patients that are readmitted	30 days post surgery	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).

Trial Locations

Locations (1)

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