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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01606657
Other study ID # 10012010
Secondary ID
Status Completed
Phase N/A
First received May 21, 2012
Last updated May 1, 2017
Start date August 2010
Est. completion date April 2015

Study information

Verified date May 2017
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date April 2015
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Community Regional Trauma and Burn Center Fresno California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
7 day phone follow-up
Secondary VAS is correlated with decreased pain after I&D 1) VAS post procedure pain score two years
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