Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06705842

Conditions

Perforated Appendicitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PVI

Usual Care

Study Details

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

Study ID

NCT06705842

Start date

Apr 7, 2025

Status verified date

Dec, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

346 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PVI

active comparator: Usual Care

Interventions

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

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.

Primary outcome measure

  • Cost-effectiveness of PVI relative to usual care [ Time Frame: 30 day follow up ]

Central Contacts and Locations

Central contacts

Dalya M Ferguson, MD, MS

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

Debbie Nguyen

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Dalya Ferguson, MD, MS

(713) 500-7640Dalya.M.Ferguson@uth.tmc.edu

Debbie Nguyen

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-12-11.