Treatment of Abdominal Abscesses With or Without Fibrinolysis

February 3, 2015 updated by: Shawn St. Peter, Children's Mercy Hospital Kansas City
The objective of this study is to evaluate the utility of fibrinolysis when draining an abdominal abscess as defined by length of stay after drainage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The hypothesis is that fibrinolysis of a abscess will shorten hospital stay compared to drainage alone.

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients under age 18 found to have an abscess in their abdomen related to perforated appendicitis that requires a drain either prior to or after appendectomy.

Exclusion Criteria:

  • Patients with known immune deficiency per medical record review
  • Patients with another condition affecting surgical decision making or recovery
  • Patients with drain unable to be placed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saline only flush of abscess
Saline alone used to flush abscess
Procedure: Saline flush of abscess
Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.
Other Names:
  • Standard saline flush of abscess
Experimental: Saline plus tPA flush of abscess
Saline plus tPA used for abscess flush
Procedure: Tissue plasminogen activator abscess flush
Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.
Other Names:
  • fibrinolytic abscess flush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 1-2 weeks
Length of time required for meeting discharge criteria
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 14, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11120126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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