Irrigation Versus no Irrigation for Cutaneous Abscess
Primary Purpose
Cutaneous Abscess
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irrigation
No Irrigation
Sponsored by
About this trial
This is an interventional diagnostic trial for Cutaneous Abscess focused on measuring I&D, Abscess, Irrigation, Cutaneous Abscess
Eligibility Criteria
Inclusion Criteria:
- All patients 18 years of age and above
- Patients that require a cutaneous abscess incision and drainage
Exclusion Criteria:
- Unable to return for 48-hour followup.
- Patients being admitted to the hospital or going to the operating room for incision and drainage
- Pregnant patients
- Prisoners
Sites / Locations
- Community Regional Trauma and Burn Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Irrigation
No Irrigation
Arm Description
THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I&D PROCEDURE
THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I&D PROCEDURE
Outcomes
Primary Outcome Measures
Patients needing further treatment after irrigation for I&D
Percentage of patients needing further treatment i. Further treatment defined as
Repeat I&D
Addition of an antibiotic (as new or to a pre-existing antibiotic)
Admission to hospital for cutaneous abscess-related problem
Abscess
Cellulitis
Septic arthritis
Sepsis
Secondary Outcome Measures
VAS is correlated with decreased pain after I&D
1) VAS post procedure pain score
Full Information
NCT ID
NCT01606657
First Posted
May 21, 2012
Last Updated
May 1, 2017
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01606657
Brief Title
Irrigation Versus no Irrigation for Cutaneous Abscess
Official Title
Is Routine Irrigation of Cutaneous Abscesses Necessary?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess
Keywords
I&D, Abscess, Irrigation, Cutaneous Abscess
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irrigation
Arm Type
Active Comparator
Arm Description
THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I&D PROCEDURE
Arm Title
No Irrigation
Arm Type
Placebo Comparator
Arm Description
THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I&D PROCEDURE
Intervention Type
Procedure
Intervention Name(s)
Irrigation
Intervention Description
The patient will receive irrigation as a part of their wound care
Intervention Type
Other
Intervention Name(s)
No Irrigation
Intervention Description
The patient will not receive irrigation as part of their wound care
Primary Outcome Measure Information:
Title
Patients needing further treatment after irrigation for I&D
Description
Percentage of patients needing further treatment i. Further treatment defined as
Repeat I&D
Addition of an antibiotic (as new or to a pre-existing antibiotic)
Admission to hospital for cutaneous abscess-related problem
Abscess
Cellulitis
Septic arthritis
Sepsis
Time Frame
7 day phone follow-up
Secondary Outcome Measure Information:
Title
VAS is correlated with decreased pain after I&D
Description
1) VAS post procedure pain score
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients 18 years of age and above
Patients that require a cutaneous abscess incision and drainage
Exclusion Criteria:
Unable to return for 48-hour followup.
Patients being admitted to the hospital or going to the operating room for incision and drainage
Pregnant patients
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Chinnock, MD
Organizational Affiliation
UCSF, Community Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Regional Trauma and Burn Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19388915
Citation
O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10.
Results Reference
background
PubMed Identifier
9137156
Citation
Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6. doi: 10.1111/j.1445-2197.1997.tb01934.x.
Results Reference
background
PubMed Identifier
3880635
Citation
Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.
Results Reference
background
PubMed Identifier
3881155
Citation
Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7. doi: 10.1002/bjs.1800720125.
Results Reference
background
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Irrigation Versus no Irrigation for Cutaneous Abscess
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