APPI-Cost Trial for Perforated Appendicitis

NCT06705842 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: HSC-MS-24-07721K12TR004908-01
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perforated Appendicitis

Keywords

Perforated Appendicitis; Povidone Iodine; Cost effectiveness; Intra-abdominal abscess; Appendectomy; Implementation science

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total patient-reported costs

  30 days, 90 days, 6 months, and 12 months

• Health-related quality of life as assessed by the EQ-5D-5L questionnaire

  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)

Study Arms (2)

PVI

ACTIVE COMPARATOR

Drug: PVI

Usual Care

ACTIVE COMPARATOR

Drug: Usual Care

Interventions

PVI DRUG

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

PVI

Usual Care DRUG

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plan to undergo appendectomy for acute appendicitis

You may not qualify if:

• 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
• Enrolled in study preoperatively
• Intraoperative diagnosis of perforated appendicitis
• Non-perforated appendicitis

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Appendicitis; Abdominal Abscess

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Abscess; Suppuration

Study Officials

• Dalya Ferguson, MD, MS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalya M Ferguson, MD, MS

CONTACT

(713) 566-5098; Dalya.M.Ferguson@uth.tmc.edu

Debbie Nguyen

CONTACT

(713) 566-5098; Debbie.F.Lew@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)