Acute, Perforated Appendicitis Clinical Trial
— PAPPAOfficial title:
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02664220 -
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
|
Phase 2 |