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

NCT ID: NCT01302548

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-08-31

Brief Summary

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.

Conditions

Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IRRISEPT

Device containing sterile water and chlorhexidine gluconate (CHG)

Group Type: EXPERIMENTAL

IRRISEPT

Intervention Type: DEVICE

Device containing sterile water and chlorhexidine gluconate (CHG)

Usual Care

The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: PROCEDURE

The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.

Interventions

IRRISEPT

Device containing sterile water and chlorhexidine gluconate (CHG)

Intervention Type: DEVICE

Usual Care

The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.

Intervention Type: PROCEDURE

Other Intervention Names

Saline irrigation; Incision & Drainage

Eligibility 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

• 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irrimax Corporation

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard F Petrik, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

20101227

Identifier Type: -

Identifier Source: org_study_id