Treatment of Abdominal Abscesses With or Without Fibrinolysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01597336
First received: May 10, 2012
Last updated: February 13, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    Length of time required for meeting discharge criteria


Estimated Enrollment: 92
Study Start Date: June 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597336

Contacts
Contact: Shawn D St. Peter, MD 816-983-6479 sspeter@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD    816-983-6479    sspeter@CMH.edu   
Contact: Susan W Sharp, PhD    816-983-6670    swsharp@CMH.edu   
Principal Investigator: Shawn D St. Peter, MD         
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

No publications provided

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
Study First Received: May 10, 2012
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 21, 2014