Abdominal AbscessNCT01597336
Treatment of Abdominal Abscesses With or Without Fibrinolysis
A study testing Tissue plasminogen activator abscess flush and Saline flush of abscess in people with Abdominal Abscess and Tissue Plasminogen Activator, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Abdominal Abscess, Tissue Plasminogen Activator
- What is being tested?
- Tissue plasminogen activator abscess flush and Saline flush of abscess
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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.
- Conditions
- Abdominal Abscess, Tissue Plasminogen Activator
- Being tested
- Tissue plasminogen activator abscess flush, Saline flush of abscess
- Keywords
- abscess, tPA
- Medical subject headings
- Abdominal Abscess, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue plasminogen activator abscess flushProcedure or surgery
Also called fibrinolytic abscess flush
Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.
Saline flush of abscessProcedure or surgery
Also called Standard saline flush of abscess
Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Saline only flush of abscess | Active comparator | Saline alone used to flush abscess Receives: Procedure: Saline flush of abscess |
| Saline plus tPA flush of abscess | Experimental | Saline plus tPA used for abscess flush Receives: Procedure: Tissue plasminogen activator abscess flush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of time required for meeting discharge criteria
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startJun 2009
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597336
- Sponsor's protocol ID
- 11120126
- Status last verified
- Feb 2015
- First submitted
- 10 May 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Abdominal Abscesses With or Without Fibrinolysis
- ClinicalTrials.gov ID
- NCT01597336
- Acronym / sponsor ID
- 11120126
- Conditions
- Abdominal Abscess, Tissue Plasminogen Activator
- Keywords
- abscess, tPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis is that fibrinolysis of a abscess will shorten hospital stay compared to drainage alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline only flush of abscess | Active comparator | Procedure: Saline flush of abscessSaline alone used to flush abscess |
| Saline plus tPA flush of abscess | Experimental | Procedure: Tissue plasminogen activator abscess flushSaline plus tPA used for abscess flush |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue plasminogen activator abscess flushAlso: fibrinolytic abscess flushThirteen ml of 10% tPA in saline at time of drain and twice daily thereafter. | Procedure or surgery | Saline plus tPA flush of abscess |
| Saline flush of abscessAlso: Standard saline flush of abscessThirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter. | Procedure or surgery | Saline only flush of abscess |
Primary outcome
Length of hospital stay
Time frame: 1-2 weeks
Length of time required for meeting discharge criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
Related trials for Abdominal Abscess
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Active, not recruitingPhase 1/2
Abdominal aBscess Catheter Sclerotherapy (ABCS)
Abdominal Abscess
Not yet recruitingPhase 3
Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess
Liver Abscess, Amoebic Liver Abscess
RecruitingObservational study
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue plasminogen activator abscess flush and Saline flush of abscess in people with Abdominal Abscess and Tissue Plasminogen Activator, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.