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Packing Versus no Packing for Cutaneous Abscess

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ClinicalTrials.gov Identifier: NCT02822768
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Cutaneous Abscess Procedure: Packing Other: No packing Not Applicable

Detailed Description:

Study protocol:

  1. Identification of a patient with a cutaneous abscess requiring incision and drainage
  2. Written consent obtained from the patient
  3. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is Routine Packing of Cutaneous Abscesses Necessary?
Study Start Date : August 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

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.
Procedure: Packing
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
Other: No packing
The patient will not receive packing as part of their wound care




Primary Outcome Measures :
  1. Percentage of patients needing further treatment [ Time Frame: 14 days ]
    follow-up call to determine if patient required further treatment beyond routine care


Secondary Outcome Measures :
  1. Visual Analog Scale for Pain (VAS pain) post procedure [ Time Frame: 14 days ]
    Measure pain score after procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients 18 years of age and above
  2. Patients that require a cutaneous abscess incision and drainage
  3. English-speaking subjects only

Exclusion Criteria:

  1. Unable to return for 48-hour follow-up.
  2. Patients being admitted to the hospital or going to the operating room for incision and drainage
  3. Pregnant patients
  4. Patients less than 18 years of age
  5. Prisoners or persons in police custody
  6. Patients with infected bursa
  7. Non-English speaking subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822768


Contacts
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Contact: Michael Darracq, MD, MPH 559-499-6440 mdarracq@fresno.ucsf.edu
Contact: Jannet Castaneda, BA 559-499-6435 jcastaneda@fresno.ucsf.edu

Locations
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United States, California
Community Regional Medical Center Recruiting
Fresno, California, United States, 93701
Contact: Michael Darracq, MD, MPH    559-499-6432    mdarracq@fresno.ucsf.edu   
Contact: Jannet Castaneda, BA    559-499-6435    jcastaneda@fresno.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Michael Darracq, MD, MPH UCSF - Fresno
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02822768    
Other Study ID Numbers: 2016052
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Abscess
Skin Diseases
Suppuration
Infection
Inflammation
Pathologic Processes