Trial record 1 of 26 for:
"Abdominal Abscess"
Treatment of Abdominal Abscesses With or Without Fibrinolysis
This study is currently recruiting participants.
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Children's Mercy Hospital Kansas City
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
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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
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:
|
Abdominal Abscess 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 May 22, 2013