Irrigation Versus no Irrigation for Cutaneous Abscess

This study is currently recruiting participants.
Verified February 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Brian Chinnock, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01606657
First received: May 21, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.


Condition Intervention
Cutaneous Abscess
Procedure: Irrigation
Other: No Irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Is Routine Irrigation of Cutaneous Abscesses Necessary?

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Patients needing further treatment after irrigation for I&D [ Time Frame: 7 day phone follow-up ] [ Designated as safety issue: No ]

    Percentage of patients needing further treatment i. Further treatment defined as

    1. Repeat I&D
    2. Addition of an antibiotic (as new or to a pre-existing antibiotic)
    3. Admission to hospital for cutaneous abscess-related problem

      1. Abscess
      2. Cellulitis
      3. Septic arthritis
      4. Sepsis


Secondary Outcome Measures:
  • VAS is correlated with decreased pain after I&D [ Time Frame: two years ] [ Designated as safety issue: No ]
    1) VAS post procedure pain score


Estimated Enrollment: 210
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Irrigation
THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I&D PROCEDURE
Procedure: Irrigation
The patient will receive irrigation as a part of their wound care
Placebo Comparator: No Irrigation
THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I&D PROCEDURE
Other: No Irrigation
The patient will not receive irrigation as part of their wound care

Detailed Description:

Irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). Despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. Potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients 18 years of age and above
  2. Patients that require a cutaneous abscess incision and drainage

Exclusion Criteria:

  1. Unable to return for 48-hour followup.
  2. Patients being admitted to the hospital or going to the operating room for incision and drainage
  3. Pregnant patients
  4. Prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606657

Contacts
Contact: Brian Chinnock, MD 5594996440 brianchinnock@gmail.com
Contact: Svetlana Bagdasarov, MPH 5594996432 sbagdasarov@fresno.ucsf.edu

Locations
United States, California
Community Regional Trauma and Burn Center Recruiting
Fresno, California, United States, 93721
Contact: Brian Chinnock, MD    559-499-6400    brianchinnock@gmail.com   
Contact: Brandy Snowden, MPH    5594996440    bsnowden@fresno.ucsf.edu   
Principal Investigator: Brian Chinnock, MD         
Sub-Investigator: Gregory Hendey, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Brian Chinnock, MD UCSF, Community Regional Medical Center
  More Information

Publications:
Responsible Party: Brian Chinnock, Associate Clinical Professor of Emergency Medicine, Director of Coding/Reimbursement, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01606657     History of Changes
Other Study ID Numbers: 10012010
Study First Received: May 21, 2012
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
I&D
Abscess
Irrigation
Cutaneous Abscess

Additional relevant MeSH terms:
Abscess
Skin Diseases
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014