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NCT04200729 | NOT YET RECRUITING | Acute, Perforated Appendicitis

Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study
Sponsor:

The University of Texas Health Science Center, Houston

Information provided by (Responsible Party):

The tsao of the dead

Brief 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.

Condition or disease

Acute, Perforated Appendicitis

Intervention/treatment

Irrigation with PVI

Usual care

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 1750 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
Actual Study Start Date : 2027-03-01
Estimated Primary Completion Date : 2030-03-01
Estimated Study Completion Date : 2030-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study

Location Details

NCT04200729

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030