Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: A Multi-center Stepped Wedge Cluster Randomized Study (PAPPA)
Primary Purpose
Acute, Perforated Appendicitis
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Irrigation with PVI
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Acute, Perforated Appendicitis
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Irrigation with PVI
Usual care
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT04200729
First Posted
December 12, 2019
Last Updated
May 22, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04200729
Brief Title
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: A Multi-center Stepped Wedge Cluster Randomized Study
Acronym
PAPPA
Official Title
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute, Perforated Appendicitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge cluster randomized trial (SW-CRT). After a period of baseline data collection, clusters will be randomized to cross over from control to intervention in a stepwise fashion until all clusters have been exposed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irrigation with PVI
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Irrigation with PVI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of patients with post operative intra-abdominal abscesses
Description
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).
Time Frame
30 days post surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay(LOS)
Description
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.
Time Frame
30 days post surgery
Title
Number of patients that are readmitted
Description
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).
Time Frame
30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuojen Tsao, MD
Phone
(713) 500-7327
Email
KuoJen.Tsao@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa Garcia
Phone
(713) 500-7434
Email
Elisa.I.Garcia@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuojen Tsao, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuojen Tsao, MD
Phone
713-500-7327
Email
KuoJen.Tsao@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Elisa Garcia
Phone
(713) 500-7434
Email
Elisa.I.Garcia@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: A Multi-center Stepped Wedge Cluster Randomized Study
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