NCT01597336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

4.6 years

First QC Date

May 10, 2012

Last Update Submit

February 3, 2015

Conditions

Abdominal AbscessTissue Plasminogen Activator

Keywords

abscesstPA

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Length of time required for meeting discharge criteria

    1-2 weeks

Study Arms (2)

Saline only flush of abscess

ACTIVE COMPARATOR

Saline alone used to flush abscess

Procedure: Saline flush of abscess

Saline plus tPA flush of abscess

EXPERIMENTAL

Saline plus tPA used for abscess flush

Procedure: Tissue plasminogen activator abscess flush

Interventions

Tissue plasminogen activator abscess flushPROCEDURE

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

Also known as: fibrinolytic abscess flush
Saline plus tPA flush of abscess
Saline flush of abscessPROCEDURE

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

Also known as: Standard saline flush of abscess
Saline only flush of abscess

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Abdominal AbscessAbscess

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

June 1, 2009

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

US(1)