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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04200729
Other study ID # HSC-MS-19-0810
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02664220 - Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis Phase 2