Treatment of Abdominal Abscesses With or Without Fibrinolysis

Sponsor

Children's Mercy Hospital Kansas City (Other)

Overall Status

Completed

CT.gov ID

NCT01597336

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Abscess Tissue Plasminogen Activator	Procedure: Tissue plasminogen activator abscess flush Procedure: Saline flush of abscess	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Abdominal Abscesses With or Without Fibrinolysis

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: fibrinolytic abscess flush

Arm

Intervention/Treatment

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 Names:

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 Names:

fibrinolytic abscess flush

Outcome Measures

Primary Outcome Measures

Length of hospital stay [1-2 weeks]
Length of time required for meeting discharge criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.