- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822768
Packing Versus no Packing for Cutaneous Abscess
Is Routine Packing of Cutaneous Abscesses Necessary?
The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if routine packing of the abscess cavity affects the need for further interventions such as repeat incision and drainage, antibiotic administration or hospital admission.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study protocol:
-
Identification of a patient with a cutaneous abscess requiring incision and drainage
-
Written consent obtained from the patient
-
Study materials will be obtained
-
Enrolling physician fills out pre-procedure information (see data sheet)
-
Enrollment data sheet has instructions indicating whether patient is to receive packing or not
- Use of random number generator to randomize all packets
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Provider does abscess incision and drainage with or without packing according to the instructions
-
Enrolling physician fills out post-procedure information (see data sheet)
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Patient returns within 48 hours for wound check with removal of packing if performed
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Research coordinator or study physician calls the patient within 14 and 30 days after the procedure for follow-up
- Information from a return visit and/or the telephone follow-up
-
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Fresno, California, United States, 93701
- Community Regional Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients 18 years of age and above
- Patients that require a cutaneous abscess incision and drainage
- English-speaking subjects only
Exclusion Criteria:
- Unable to return for 48-hour follow-up.
- Patients being admitted to the hospital or going to the operating room for incision and drainage
- Pregnant patients
- Patients less than 18 years of age
- Prisoners or persons in police custody
- Patients with infected bursa
- Non-English speaking subjects
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Packing
The patient is to have a long piece of gauze within the abscess cavity in an attempt to keep it open and allow purulent material to continue to drain after the initial incision and release of purulent material has been performed. |
The patient will receive packing as part of their wound care |
|
Placebo Comparator: No packing
The patient is not to have packing of the abscess as part of the incision and drainage procedure |
The patient will not receive packing as part of their wound care |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients needing further treatment
Time Frame: 14 days
|
follow-up call to determine if patient required further treatment beyond routine care |
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for Pain (VAS pain) post procedure
Time Frame: 14 days
|
Measure pain score after procedure |
14 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Darracq, MD, MPH, UCSF - Fresno
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Barnes SM, Milsom PL. Abscesses: an open and shut case! Arch Emerg Med. 1988 Dec;5(4):200-5. doi: 10.1136/emj.5.4.200.
- Simms MH, Curran F, Johnson RA, Oates J, Givel JC, Chabloz R, ALexander-Williams J. Treatment of acute abscesses in the casualty department. Br Med J (Clin Res Ed). 1982 Jun 19;284(6332):1827-9. doi: 10.1136/bmj.284.6332.1827.
- Sorensen C, Hjortrup A, Moesgaard F, Lykkegaard-Nielsen M. Linear incision and curettage vs. deroofing and drainage in subcutaneous abscess. A randomized clinical trial. Acta Chir Scand. 1987 Nov-Dec;153(11-12):659-60.
- Tonkin DM, Murphy E, Brooke-Smith M, Hollington P, Rieger N, Hockley S, Richardson N, Wattchow DA. Perianal abscess: a pilot study comparing packing with nonpacking of the abscess cavity. Dis Colon Rectum. 2004 Sep;47(9):1510-4. doi: 10.1007/s10350-004-0620-1. Epub 2004 Jul 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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