NCT01597336CompletedNot Applicable
Treatment of Abdominal Abscesses With or Without Fibrinolysis
Children's Mercy Hospital Kansas City1 site in 1 country92 target enrollmentStarted: June 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saline only flush of abscess
Active Comparator
Saline alone used to flush abscess
Intervention: Saline flush of abscess (Procedure)
Saline plus tPA flush of abscess
Experimental
Saline plus tPA used for abscess flush
Intervention: Tissue plasminogen activator abscess flush (Procedure)
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: 1-2 weeks
Length of time required for meeting discharge criteria
Secondary Outcomes
No secondary outcomes reported
Investigators
Shawn St. Peter
Associate Professor
Children's Mercy Hospital Kansas City
Study Sites (1)
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