Treatment of Abdominal Abscesses With or Without Fibrinolysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Abdominal Abscess Tissue Plasminogen Activator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saline only flush of abscess

Saline alone used to flush abscess

Group Type ACTIVE_COMPARATOR

Saline flush of abscess

Intervention Type PROCEDURE

Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.

Saline plus tPA flush of abscess

Saline plus tPA used for abscess flush

Group Type EXPERIMENTAL

Tissue plasminogen activator abscess flush

Intervention Type PROCEDURE

Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.

Interventions

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Tissue plasminogen activator abscess flush

Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.

Intervention Type PROCEDURE

Saline flush of abscess

Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.

Intervention Type PROCEDURE

Other Intervention Names

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fibrinolytic abscess flush Standard saline flush of abscess

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No