Actively Recruiting
The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
Led by The University of Texas Health Science Center, Houston · Updated on 2025-12-11
346
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
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 mL/kg 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 surgeon's 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.
CONDITIONS
Brief Title
APPI-Cost Trial for Perforated Appendicitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Plan to undergo appendectomy for acute appendicitis
- Enrolled in study preoperatively
- Intraoperative diagnosis of perforated appendicitis
- Age 18 years or older
You will not qualify if you...
- Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
- Allergy to iodine
- Uncontrolled hyper- or hypothyroidism
- Renal dysfunction
- Pregnant or breastfeeding
- Primary language neither English nor Spanish
- Lack of functioning telephone or email account
- Incarcerated or in police custody
- Non-perforated appendicitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Index admission (variable duration)
Participants undergo appendectomy with intraoperative randomization to receive either povidone-iodine irrigation or usual care irrigation during surgery.
1 surgical procedure and hospital stay
Duration - Up to 12 months
Participants are monitored for postoperative complications and recovery, with assessments of costs and quality of life over time.
Follow-up visits at 30 days, 90 days, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Dalya M Ferguson, MD, MS
D
Debbie Nguyen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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