Back to resultsTreatment of Abdominal Abscesses With or Without Fibrinolysis
Primary Purpose
Abdominal Abscess, Tissue Plasminogen Activator
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tissue plasminogen activator abscess flush
Saline flush of abscess
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Abscess focused on measuring abscess, tPA
Eligibility 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
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Saline only flush of abscess
Saline plus tPA flush of abscess
Arm Description
Saline alone used to flush abscess
Saline plus tPA used for abscess flush
Outcomes
Primary Outcome Measures
Length of hospital stay
Length of time required for meeting discharge criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT01597336
First Posted
May 10, 2012
Last Updated
February 3, 2015
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT01597336
Brief Title
Treatment of Abdominal Abscesses With or Without Fibrinolysis
Official Title
Treatment of Abdominal Abscesses With or Without Fibrinolysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The hypothesis is that fibrinolysis of a abscess will shorten hospital stay compared to drainage alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Abscess, Tissue Plasminogen Activator
Keywords
abscess, tPA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saline only flush of abscess
Arm Type
Active Comparator
Arm Description
Saline alone used to flush abscess
Arm Title
Saline plus tPA flush of abscess
Arm Type
Experimental
Arm Description
Saline plus tPA used for abscess flush
Intervention Type
Procedure
Intervention Name(s)
Tissue plasminogen activator abscess flush
Other Intervention Name(s)
fibrinolytic abscess flush
Intervention Description
Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.
Intervention Type
Procedure
Intervention Name(s)
Saline flush of abscess
Other Intervention Name(s)
Standard saline flush of abscess
Intervention Description
Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of time required for meeting discharge criteria
Time Frame
1-2 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
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Treatment of Abdominal Abscesses With or Without Fibrinolysis
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