Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study

NCT04200729 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HSC-MS-19-0810
• Study Type: interventional
• Target: 1,750
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.

Conditions

Acute, Perforated Appendicitis

Outcome Measures

Primary Outcomes (1)

• number of patients with post operative intra-abdominal abscesses

  An IAA will be defined as: an image-confirmed (ultrasound, CT, or MRI) fluid collection deemed to be an IAA by an attending radiologist or pediatric surgeon, or an abscess confirmed during percutaneous intervention (aspiration of purulent fluid) or reoperation (direct visualization of purulent fluid).

  30 days post surgery

Secondary Outcomes (2)

• Length of hospital stay(LOS)

  30 days post surgery

• Number of patients that are readmitted

  30 days post surgery

Study Arms (2)

Irrigation with PVI

EXPERIMENTAL

Drug: Irrigation with PVI

Usual care

ACTIVE COMPARATOR

Procedure: Usual care

Interventions

Irrigation with PVI DRUG

The intervention will be irrigation with PVI, diluted to a concentration of 1% (containing 0.1% active iodine). After removal of the appendix from the patient's abdomen and attainment of hemostasis,10 mL/kg of 1% PVI solution 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.

Irrigation with PVI

Usual care PROCEDURE

The control will be usual care, which is expected to vary between institutions. The only stipulation for usual care will be that surgeons do not change their usual practice during the baseline period. Some surgeons utilize intra-abdominal irrigation while others use only local irrigation. Intraabdominal irrigation is defined as intraoperative instillation of a large volume (\> 200 mL) of irrigation solution into all 4 quadrants of the abdomen. Local irrigation is defined as instillation of a small volume of liquid, typically \<50 mL, in the operative field. Intra-abdominal irrigation is utilized with the intention of preventing IAAs while local irrigation is often used to confirm hemostasis or assist with suctioning thick purulent fluid.

Usual care

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Admitted to a participating center
• Appendectomy performed for acute appendicitis
• Intraoperative diagnosis of perforated appendicitis

You may not qualify if:

• Simple or gangrenous appendicitis
• Interval or incidental appendectomy
• Initial attempt at non-operative management (defined as \>48 hours between the time of diagnosis and surgical intervention)
• History of iodine allergy, thyroid disease or renal dysfunction
• Pregnancy

Sponsors & Collaborators

• 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

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Kuojen Tsao, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuojen Tsao, MD

CONTACT

(713) 500-7327; KuoJen.Tsao@uth.tmc.edu

Elisa Garcia

CONTACT

(713) 500-7434; Elisa.I.Garcia@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge cluster randomized trial (SW-CRT). After a period of baseline data collection, clusters will be randomized to cross over from control to intervention in a stepwise fashion until all clusters have been exposed.

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)