- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04200729
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: A Multi-center Stepped Wedge Cluster Randomized Study (PAPPA)
May 22, 2023 updated by: KuoJen Tsao, The University of Texas Health Science Center, Houston
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1750
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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
Time Frame: 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).
|
30 days post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay(LOS)
Time Frame: 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.
|
30 days post surgery
|
Number of patients that are readmitted
Time Frame: 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).
|
30 days post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kuojen Tsao, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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