Assessing the effectiveness of povidone-iodine irrigation for perforated appendicitis
The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
This study tests if using povidone-iodine irrigation during surgery can help people with perforated appendicitis recover better and save on treatment costs compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 346 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06705842 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and cost-effectiveness of using povidone-iodine (PVI) irrigation in patients undergoing appendectomy for perforated appendicitis. It aims to identify barriers and facilitators to the implementation of PVI irrigation and to gather data on costs, clinical outcomes, and patient-reported outcomes. The study will compare the outcomes of patients receiving PVI irrigation to those receiving usual care during their treatment.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for appendectomy due to acute appendicitis with an intraoperative diagnosis of perforated appendicitis.
Not a fit: Patients with non-perforated appendicitis or those with significant preoperative complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and reduce healthcare costs for patients with perforated appendicitis.
How similar studies have performed: Other studies have explored the use of povidone-iodine in surgical settings, but this specific application for perforated appendicitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility for Enrollment Inclusion Criteria: * Plan to undergo appendectomy for acute appendicitis Exclusion Criteria: * 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 Eligibility for Randomization Inclusion Criteria: * Enrolled in study preoperatively * Intraoperative diagnosis of perforated appendicitis Exclusion Criteria: * Non-perforated appendicitis
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dalya Ferguson, MD, MS — The University of Texas Health Science Center, Houston
- Study coordinator: Dalya M Ferguson, MD, MS
- Email: Dalya.M.Ferguson@uth.tmc.edu
- Phone: (713) 566-5098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.