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

NCT01302548 | Terminated Results DMC

• 1 other identifier: 20101227
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Abscess; Wound Irrigation; Wound Debridement; Wound Healing; Incision and drainage; Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Abscess Healing Based on Abscess Measurement Scale

  The abscess healing process will use two methods: 1) "usual method" includes saline irrigation and/or incision \& drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler. Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild

  48 hours

Secondary Outcomes (2)

• Number of Patients Prescribed Oral Antibiotics

  48 hours

• Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.

  48 hours

Study Arms (2)

IRRISEPT

EXPERIMENTAL

Device containing sterile water and chlorhexidine gluconate (CHG)

Device: IRRISEPT

Usual Care

ACTIVE COMPARATOR

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

Procedure: Usual Care

Interventions

IRRISEPT DEVICE

Device containing sterile water and chlorhexidine gluconate (CHG)

IRRISEPT

Usual Care PROCEDURE

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

Also known as: Saline irrigation, Incision & Drainage

Usual Care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Irrimax Corporation: collaborator

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Abscess; Surgical Wound

Interventions

Drainage

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Richard F Petrik, MD
• Organization: University of Florida

rpetrik@ufl.edu

352-265-5911

Study Officials

• Richard F Petrik, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-02

Locations

US (1)