Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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
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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Dalya Ferguson, MD, MS
713-500-7640
Dalya.M.Ferguson@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.