Study of Povidone-Iodine Irrigation to Prevent Abscess After Surgery for Perforated Appendicitis Assessing Clinical and Cost Effectiveness Compared to Usual Care

What this Trial Is About

The trial investigates the clinical and cost-effectiveness of using povidone-iodine PVI irrigation during surgery for patients with perforated appendicitis. It aims to understand barriers and facilitators for implementing PVI irrigation and to collect cost and patient-reported outcomes for those with non-perforated appendicitis. This is a phase 4 randomized study sponsored by The University of Texas Health Science Center, Houston. Participants undergoing appendectomy for perforated appendicitis will be randomly assigned to receive either PVI irrigation or usual care. In the PVI group, after appendix removal and controlling bleeding, 10 mLkg of 1% PVI up to 1,000 mL is used to irrigate the pelvis and abdominal quadrants, left to dwell for 1 minute, then suctioned out. The usual care group may receive local or large volume saline irrigation as per the surgeons practice but will not receive PVI irrigation. Participants will be followed to assess cost-effectiveness at 30 days, including hospital costs, length of stay, complications, and patient-reported costs and quality of life up to 12 months. Additional outcomes include days of work missed and postoperative complications. The study includes single-blind monitoring and tracks health-related quality of life with the EQ-5D-5L questionnaire.

APPI-Cost Trial for Perforated Appendicitis