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

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ClinicalTrials.gov Identifier: NCT04200729
Recruitment Status : Not yet recruiting
First Posted : December 16, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
KuoJen Tsao, 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.

Condition or disease Intervention/treatment Phase
Acute, Perforated Appendicitis Drug: Irrigation with PVI Procedure: Usual care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1750 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Appendicitis
Drug Information available for: Iodine

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200729


Contacts
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Contact: Kuojen Tsao, MD (713) 500-7327 KuoJen.Tsao@uth.tmc.edu
Contact: Elisa Garcia (713) 500-7434 Elisa.I.Garcia@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Kuojen Tsao, MD    713-500-7327    KuoJen.Tsao@uth.tmc.edu   
Contact: Elisa Garcia    (713) 500-7434    Elisa.I.Garcia@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Kuojen Tsao, MD The University of Texas Health Science Center, Houston
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Responsible Party: KuoJen Tsao, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04200729    
Other Study ID Numbers: HSC-MS-19-0810
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Abdominal Abscess
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Abscess
Suppuration