Treatment of Abdominal Abscesses With or Without Fibrinolysis

Abdominal Abscess Clinical Trial

Official title:

Treatment of Abdominal Abscesses With or Without Fibrinolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597336
• Other study ID #: 11120126
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: February 3, 2015
• Start date: June 2009
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Abscess
• Abscess
• Tissue Plasminogen Activator

Intervention

Procedure:
• Tissue plasminogen activator abscess flush
Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.
• Saline flush of abscess
Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Length of time required for meeting discharge criteria	1-2 weeks	No