Clinical trial
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
Name
HSC-MS-19-0810
Description
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.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Irrigation with PVI
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.
Arms:
Usual care
Size
1750
Primary endpoint
number of patients with post operative intra-abdominal abscesses
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Stepped-wedge cluster randomized trial (SW-CRT). After a period of baseline data collection, clusters will be randomized to cross over from control to intervention in a stepwise fashion until all clusters have been exposed.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1750, 'type': 'ESTIMATED'}}
Updated at
2023-05-24
1 organization