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Treatment of Abdominal Abscesses With or Without Fibrinolysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597336
First Posted: May 14, 2012
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
  Purpose
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.

Condition Intervention
Abdominal Abscess Tissue Plasminogen Activator Procedure: Tissue plasminogen activator abscess flush Procedure: Saline flush of abscess

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Abdominal Abscesses With or Without Fibrinolysis

Resource links provided by NLM:


Further study details as provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: 1-2 weeks ]
    Length of time required for meeting discharge criteria


Estimated Enrollment: 92
Study Start Date: June 2009
Study Completion Date: May 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: fibrinolytic abscess flush

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597336


Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
  More Information

Responsible Party: Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01597336     History of Changes
Other Study ID Numbers: 11120126
First Submitted: May 10, 2012
First Posted: May 14, 2012
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
abscess
tPA

Additional relevant MeSH terms:
Abscess
Abdominal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action