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CompletedNCT01597336Updated Feb 4, 2015

Treatment of Abdominal Abscesses With or Without Fibrinolysis

An interventional study of Tissue plasminogen activator abscess flush and Saline flush of abscess in Abdominal Abscess and Tissue Plasminogen Activator, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2015-02-04.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Abdominal Abscess
  • Tissue Plasminogen Activator

Keywords

  • abscess
  • tPA
03

In context

Abdominal Abscess

31 studies on the registry are indexed under Abdominal Abscess; 5 are open to participants now.

This study's planned enrollment of 92 is below the median of 105 across 24 interventional studies indexed under Abdominal Abscess.

Browse Abdominal Abscess studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Browse Children's Mercy Hospital Kansas City studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Active comparator
    Saline only flush of abscess

    Saline alone used to flush abscess

    Procedure: Saline flush of abscess

  • Experimental
    Saline plus tPA flush of abscess

    Saline plus tPA used for abscess flush

    Procedure: Tissue plasminogen activator abscess flush

Interventions

  • ProcedureTissue plasminogen activator abscess flush

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

    Also known as: fibrinolytic abscess flush

  • ProcedureSaline flush of abscess

    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

06

What researchers measure

Primary outcomes

  1. Length of hospital stay

    Length of time required for meeting discharge criteria

    Time frame: 1-2 weeks

07

Study locations

1 site
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2009, a primary completion of Jan 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2012
First posted
May 14, 2012
Start
Jun 2009
Primary completionActual
Jan 2014
CompletionActual
May 2014
Last update
Feb 4, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01597336
Lead sponsor
Children's Mercy Hospital Kansas City
Responsible party
Shawn St. Peter (Associate Professor, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
May 14, 2012
Start date
Jun 2009
Primary completion
Jan 2014
Completion
May 2014
Last update
Feb 4, 2015

Study contacts

Shawn D St. Peter, MD
principal investigator · Children's Mercy Hospital and Clinics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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