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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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cutaneous Abscess focused on measuring I&D, Abscess, Irrigation, Cutaneous Abscess

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
May 21, 2012
Last Updated
May 1, 2017
Sponsor
University of California, San Francisco
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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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