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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

Tracking Information
First Submitted Date  ICMJE June 30, 2016
First Posted Date  ICMJE July 4, 2016
Last Update Posted Date March 16, 2020
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Percentage of patients needing further treatment [ Time Frame: 14 days ]
follow-up call to determine if patient required further treatment beyond routine care
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
Percentage of patients needing further treatment [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Visual Analog Scale for Pain (VAS pain) post procedure [ Time Frame: 14 days ]
Measure pain score after procedure
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
Visual Analog Scale for Pain (VAS pain) post procedure [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Packing Versus no Packing for Cutaneous Abscess
Official Title  ICMJE Is Routine Packing of Cutaneous Abscesses Necessary?
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:

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cutaneous Abscess
Intervention  ICMJE
  • Procedure: Packing
    The patient will receive packing as part of their wound care
  • Other: No packing
    The patient will not receive packing as part of their wound care
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Packing
  • Placebo Comparator: No packing
    The patient is not to have packing of the abscess as part of the incision and drainage procedure
    Intervention: Other: No packing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2016)
196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Darracq, MD, MPH 559-499-6440 mdarracq@fresno.ucsf.edu
Contact: Jannet Castaneda, BA 559-499-6435 jcastaneda@fresno.ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02822768
Other Study ID Numbers  ICMJE 2016052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Darracq, MD, MPH UCSF - Fresno
PRS Account University of California, San Francisco
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP