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

Acute, Perforated Appendicitis Clinical Trial

— PAPPA  

Official title:

Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04200729
• Other study ID #: HSC-MS-19-0810
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Kuojen Tsao, MD
• Phone: (713) 500-7327
• Email: KuoJen.Tsao[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1750
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Abscess
• Acute, Perforated Appendicitis
• Appendicitis

Intervention

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.

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	30 days post surgery
Secondary	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.	30 days post surgery
Secondary	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).	30 days post surgery