Expired Study
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Gainesville, Florida 32610


Purpose:

The purpose of this study is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.


Criteria:

Inclusion Criteria: - Immunocompetent individuals 12 years of age or older with an uncomplicated abscess - Patient must be able to answer questions and be medically stable as defined by the Emergency Department physician - Patient must voluntarily participate in the study Exclusion Criteria:Patients with any of the following are excluded: - Currently receiving antibiotics or received antibiotics within last 72 hours - Evidence of systemic infection (fever, aches, chills, nausea) - Requires admission to the hospital for infection or for any other reason(s) - Abscess caused by a human or animal bite - Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG) - Immunodeficiency (Examples: HIV Positive, Crohns Disease, Systemic Lupus Erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer on chemotherapy) - Currently on any immune-modifying medication (Examples: prednisone, antivirals) - History of chronic skin infection (3 or more in the past year) - Chronic medical problem, for example end-stage heart, liver, kidney, or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant - Mental illness including but not limited to substance abuse, dementia, schizophrenia or mentally handicapped or challenged - Incarcerated - Patient is pregnant or thinks she may be pregnant


Study is Available At:


Original ID:

20101227


NCT ID:

NCT01302548


Secondary ID:


Study Acronym:


Brief Title:

The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department


Official Title:

THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Florida


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

33


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard F Petrik, MD
Principal Investigator
University of Florida

Study Dates

Start Date:February 2011
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:August 2012
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 17, 2013
First Received Date:September 29, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Compared to "usual care methods" the use of IRRISEPT solution on abscesses will improve healing.
Time Frame:48 hours
Safety Issues:False
Description:"usual methods" include saline irrigation and incision & drainage
Outcome Type:Secondary Outcome
Measure:Assess whether use of IRRISEPT could lead to fewer patients requiring oral antibiotics.
Time Frame:48 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Access effectiveness of IRRISEPT with patients that are MRSA-positive.
Time Frame:48 hours
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:IRRISEPT
Description:Device containing sterile water and chlorhexidine gluconate (CHG)
Arm Name:IRRISEPT
Intervention Type:Procedure
Name:Usual Care
Description:The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Arm Name:Usual Care
Other Name:Saline irrigation

Study Arms

Study Arm Type:Experimental
Arm Name:IRRISEPT
Description:Device containing sterile water and chlorhexidine gluconate (CHG)
Study Arm Type:Active Comparator
Arm Name:Usual Care
Description:The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Florida
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Irrimax Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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