Packing Versus no Packing for Cutaneous Abscess
Primary Purpose
Cutaneous Abscess
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Packing
No packing
Sponsored by
About this trial
This is an interventional diagnostic trial for Cutaneous Abscess
Eligibility Criteria
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
Sites / Locations
- Community Regional Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Packing
No packing
Arm Description
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 is not to have packing of the abscess as part of the incision and drainage procedure
Outcomes
Primary Outcome Measures
Percentage of patients needing further treatment
follow-up call to determine if patient required further treatment beyond routine care
Secondary Outcome Measures
Visual Analog Scale for Pain (VAS pain) post procedure
Measure pain score after procedure
Full Information
NCT ID
NCT02822768
First Posted
June 30, 2016
Last Updated
June 26, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02822768
Brief Title
Packing Versus no Packing for Cutaneous Abscess
Official Title
Is Routine Packing of Cutaneous Abscesses Necessary?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
Provider does abscess incision and drainage with or without packing according to the instructions
Enrolling physician fills out post-procedure information (see data sheet)
Patient returns within 48 hours for wound check with removal of packing if performed
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Packing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No packing
Arm Type
Placebo Comparator
Arm Description
The patient is not to have packing of the abscess as part of the incision and drainage procedure
Intervention Type
Procedure
Intervention Name(s)
Packing
Intervention Description
The patient will receive packing as part of their wound care
Intervention Type
Other
Intervention Name(s)
No packing
Intervention Description
The patient will not receive packing as part of their wound care
Primary Outcome Measure Information:
Title
Percentage of patients needing further treatment
Description
follow-up call to determine if patient required further treatment beyond routine care
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain (VAS pain) post procedure
Description
Measure pain score after procedure
Time Frame
14 days
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Darracq, MD, MPH
Phone
559-499-6440
Email
mdarracq@fresno.ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jannet Castaneda, BA
Phone
559-499-6435
Email
jcastaneda@fresno.ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Darracq, MD, MPH
Organizational Affiliation
UCSF - Fresno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Darracq, MD, MPH
Phone
559-499-6432
Email
mdarracq@fresno.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jannet Castaneda, BA
Phone
559-499-6435
Email
jcastaneda@fresno.ucsf.edu
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
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
PubMed Identifier
3069102
Citation
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.
Results Reference
background
PubMed Identifier
6805714
Citation
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.
Results Reference
background
PubMed Identifier
3324596
Citation
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.
Results Reference
background
PubMed Identifier
15486749
Citation
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.
Results Reference
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Packing Versus no Packing for Cutaneous Abscess
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