Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irrigation with PVI, Usual care.
- Who it may be relevant to
- Registry conditions: Acute, Perforated Appendicitis. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
Overview
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.
Interventions
- 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 sma
Primary outcome measures
- number of patients with post operative intra-abdominal abscesses [Time frame: 30 days post surgery]
Secondary outcome measures (2)
- Length of hospital stay(LOS) [Time frame: 30 days post surgery]
- Number of patients that are readmitted [Time frame: 30 days post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT04200729 · HSC-MS-19-0810