A Phase 4 interventional study of Irrigation with PVI and Usual care in Acute, Perforated Appendicitis, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Prevention
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 1,750 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Drug: Irrigation with PVI
Procedure: Usual care
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.
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
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
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.
Time frame: 30 days post surgery
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).
Time frame: 30 days post surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Mar 2030, 36 months later.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →