NCT02664220

Brief Summary

The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal irrigation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 17, 2019

Completed
Last Updated

April 17, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

December 21, 2015

Results QC Date

March 6, 2019

Last Update Submit

March 27, 2019

Conditions

Acute, Perforated Appendicitis

Keywords

Povidone-iodine irrigation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Postoperative Intra-abdominal Abscess

    30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol

    30 days post surgery

Secondary Outcomes (3)

  • Total Hospital Length of Stay

    30 days post surgery

  • Number of Participants Who Were Readmitted to the Hospital

    30 days post surgery

  • Number of Participants Who Visited the Emergency Room

    30 days post surgery

Study Arms (2)

Povidone-iodine irrigation

EXPERIMENTAL
Drug: Povidone-iodine irrigation

No irrigation

ACTIVE COMPARATOR
Procedure: No irrigation

Interventions

Povidone-iodine irrigationDRUG

Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis. 1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.

Povidone-iodine irrigation
No irrigationPROCEDURE

Patients allocated to the control group will not undergo intra-abdominal irrigation.

No irrigation

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)

You may not qualify if:

  • Patients presenting with simple or gangrenous appendicitis
  • Patients with a history of iodine sensitivity, thyroid disease or renal disease
  • Patients undergoing interval or incidental appendectomy
  • Patients/parents/legal guardians who are both non-English and non-Spanish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Anderson KT, Putnam LR, Bartz-Kurycki MA, Hamilton EC, Yafi M, Pedroza C, Austin MT, Kawaguchi AL, Kao LS, Lally KP, Tsao K. Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial. Ann Surg. 2020 May;271(5):827-833. doi: 10.1097/SLA.0000000000003398.

    PMID: 31567357DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Results Point of Contact

Title
Dr. Kuojen Tsao
Organization
McGovern Medical School, University of Texas Health Sciences Center at Houston
Kuojen.Tsao@uth.tmc.edu
713-500-7300

Study Officials

  • KuoJen Tsao, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 21, 2015

First Posted

January 26, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 17, 2019

Results First Posted

April 17, 2019

Record last verified: 2019-03

Locations

US(1)