APPI-Cost Trial for Perforated Appendicitis

The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis

The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.

Study Overview

• Status: Recruiting
• Conditions: Perforated Appendicitis
• Intervention / Treatment: Drug: PVI; Drug: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 346
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dalya M Ferguson, MD, MS; Phone Number: (713) 566-5098; Email: Dalya.M.Ferguson@uth.tmc.edu
• Study Contact Backup: Name: Debbie Nguyen; Phone Number: (713) 566-5098; Email: Debbie.F.Lew@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Debbie Nguyen; Phone Number: (713) 566-5098; Email: Debbie.F.Lew@uth.tmc.edu
      • Contact: Dalya Ferguson, MD, MS; Phone Number: (713) 500-7640; Email: Dalya.M.Ferguson@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Drug: Usual Care; Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (<100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.
Active Comparator: PVI	Drug: PVI; After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL/kg of 1% PVI (up to a maximum of 1,000 mL) 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 out

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of PVI relative to usual care	Cost-effectiveness of PVI irrigation relative to usual care will be assessed as the incremental 30-day total societal costs per percent reduction in IAA rate. The Incremental Cost Effectiveness Ratio (ICER) will be calculated as: (societal costs with PVI irrigation minus societal costs with usual care) divided by (IAA rate with PVI minus IAA rate with usual care). IAA will be defined as an image-confirmed fluid collection deemed to be an IAA by an attending surgeon or radiologist, or an abscess confirmed during percutaneous intervention or reoperation. Societal costs will be defined as patient-reported costs plus medical costs for inpatient and outpatient care within 30 days from randomization. PVI will be deemed cost-effective by either 1) reducing 30-day IAA rate without increasing 30-day total societal costs, 2) reducing 30-day total societal costs without increasing 30-day IAA rate, or 3) reducing both 30-day societal costs and IAA rate.	30 day follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total patient-reported costs	Patient-reported costs will be assessed using a patient survey, which will be verbally administered by research personnel at each time point specified.	30 days, 90 days, 6 months, and 12 months
Health-related quality of life as assessed by the EQ-5D-5L questionnaire	This is a 6 item questionnaire and the first 5 questions are each scored from 1 (no problem) - 5 (unable to), for a maximum score of 25, with a higher number indicating a worse outcome. The 6th question is scored on a Likert scale from 0 (worst health you can imagine) - 100 (best health you can imagine), with a higher score indicating a worse outcome.	30 days, 90 days, 6 months, and 12 months
Index admission total hospital costs		Index admission (variable duration)
90-day total hospital costs		90 day follow up
Index admission total length of hospital stay		Index admission (variable duration)
90-day total length of hospital stay		90 day follow up
Number of days of work missed by participant		12 months
Postoperative complications	Complications include IAA, clinically relevant IAA, superficial/deep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality	90 days follow up

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Dalya Ferguson, MD, MS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cost effectiveness; Povidone Iodine; Implementation science; Appendectomy; Perforated Appendicitis; Intra-abdominal abscess
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Suppuration; Cecal Diseases; Intraabdominal Infections; Abscess; Appendicitis; Abdominal Abscess
• Other Study ID Numbers: HSC-MS-24-0772; 1K12TR004908-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Starting 6 months after study publication, de-identified data and study materials may be made available to researchers on a case-by-case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No