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
|Condition or disease||Intervention/treatment||Phase|
|Acute, Perforated Appendicitis||Drug: Irrigation with PVI Procedure: Usual care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1750 participants|
|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)|
|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|
|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.
- 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).
- 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.
- 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).
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
|Contact: Kuojen Tsao, MD||(713) 500-7327||KuoJen.Tsao@uth.tmc.edu|
|Contact: Elisa Garcia||(713) 500-7434||Elisa.I.Garcia@uth.tmc.edu|
|Principal Investigator:||Kuojen Tsao, MD||The University of Texas Health Science Center, Houston|