Irrigation Versus no Irrigation for Cutaneous Abscess

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brian Chinnock, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01606657
First received: May 21, 2012
Last updated: September 10, 2014
Last verified: September 2014

May 21, 2012
September 10, 2014
August 2010
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01606657 on ClinicalTrials.gov Archive Site
VAS is correlated with decreased pain after I&D [ Time Frame: two years ] [ Designated as safety issue: No ]
1) VAS post procedure pain score
Same as current
Not Provided
Not Provided
 
Irrigation Versus no Irrigation for Cutaneous Abscess
Is Routine Irrigation of Cutaneous Abscesses Necessary?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cutaneous Abscess
  • Procedure: Irrigation
    The patient will receive irrigation as a part of their wound care
  • Other: No Irrigation
    The patient will not receive irrigation as part of their wound care
  • Active Comparator: Irrigation
    THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I&D PROCEDURE
    Intervention: Procedure: Irrigation
  • Placebo Comparator: No Irrigation
    THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I&D PROCEDURE
    Intervention: Other: No Irrigation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01606657
10012010
No
Brian Chinnock, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Brian Chinnock, MD UCSF, Community Regional Medical Center
University of California, San Francisco
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP