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Loop Drainage: Effectiveness in Treating Cutaneous Abscesses

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ClinicalTrials.gov Identifier: NCT02697279
Recruitment Status : Terminated (Unable to enroll the appropriate number of subjects within a reasonable timeframe.)
First Posted : March 3, 2016
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Gentry Wilkerson, University of Maryland, College Park

Brief Summary:
In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Additionally, compliance with wound care and follow-up can present barriers to proper care and healing. Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess. Thus far, research into this procedure has been limited to the pediatric population with small sample sizes. In these previous studies, this technique was found to be an effective and less painful treatment for abscesses. Research has not been done in the adult population using this procedure. If this procedure is found to be as effective and less painful in the adult population, then it should be considered as a potential preferred I&D method for cutaneous abscess in the ED.

Condition or disease Intervention/treatment Phase
Abscess of Skin and/or Subcutaneous Tissue Procedure: Traditional Incision and Drainage. Procedure: Loop drainage Not Applicable

Detailed Description:

Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study, will be consented. Study subjects will be enrolled and randomly assigned to either the study or control groups.

Control Group- standard I & D method for cutaneous abscess.

Study Group- Loop Technique:

  1. Gather all of your material and bring to bedside
  2. Clean area with chlorhexidine or iodine swabs
  3. Anesthetize area
  4. Use your scalpel to make small 5mm incision at most fluctuant area of abscess
  5. Explore cavity with your hemostat and break down loculations
  6. Make second incision less than 4cm away from first incision. Feel borders of abscess, and try to make second incision as far within cavity as you can.
  7. For larger abscesses can repeat step 5 thus creating several LOOPs.
  8. Irrigate cavity with saline flush
  9. Pass hemostat through both incisions and pull loop vessel, penrose, or bottom of glove through. Keep your loop device equal in length on both sides.
  10. Tie loop device loosely over 30cc syringe to form LOOP. Usually 5-6 knots. This helps prevent loop from falling out prematurely.
  11. Slide syringe out, and trim free ends of loop. Make sure loop is mobile.
  12. Cover site with dry dressing. Follow-Up-

    • Wound check in 1-2 days
    • Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
    • Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses
Study Start Date : October 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Active Comparator: Traditional Incision and Drainage
Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider.
Procedure: Traditional Incision and Drainage.
Control Group- Standard treatment of a simple cutaneous abscess with traditional I&D technique with or without packing utilizing a standard I&D kit.

Experimental: Loop drainage
Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique.
Procedure: Loop drainage
Study Group- Treatment of a simple cutaneous abscess with the loop drainage technique utilizing an standard I&D kit and the cuff of a sterile glove for a loop device.




Primary Outcome Measures :
  1. Procedure failure rate [ Time Frame: 5 -7 days after procedure ]
    Determining the difference in failure rates between the study group and control group. Treatment failure is a composite outcome defined as having the presence of any of the following: requiring a 2nd incision and drainage procedure, a patient that requires administration of antibiotics after the initial treatment period due to worsening clinical status, a patient that requires hospitalization after the initial treatment period due to worsening clinical status.


Secondary Outcome Measures :
  1. Difference in pain associated with the procedure using a visual analog pain scale [ Time Frame: Measured after the procedure on day 1 ]
    To evaluate the difference in pain between the experimental and control groups associated with the procedure using a visual analog pain scale (0-100).

  2. Patient Satisfaction using a visual analog pain scale [ Time Frame: 5-7 days after procedure ]
    To measure the difference in patient satisfaction with overall treatment between the study and control groups using the visual analog scale (0-100).



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. 18 years or older
  2. Presents to ED with simple cutaneous abscess
  3. Provides informed consent.

Exclusion Criteria:

  1. Under 18 years of age
  2. Abscess too small for performance of procedure
  3. Signs of systemic infection
  4. Need for hospitalization
  5. Previously treated for current abscess
  6. Clinician determines abscess would not be amenable to drainage by loop technique
  7. Patients known to be pregnant
  8. Incarcerated patients
  9. Students / Employees of the facility
  10. Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.

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): NCT02697279


Locations
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United States, Maryland
University of Maryland Medical Systems
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: R. Gentry Wilkerson, MD U of Maryland, Baltimore
Publications:
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Responsible Party: Richard Gentry Wilkerson, Assistant Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02697279    
Other Study ID Numbers: HP-00066974
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard Gentry Wilkerson, University of Maryland, College Park:
Abscess
Loop
Drainage
Additional relevant MeSH terms:
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Abscess
Suppuration
Infection
Inflammation
Pathologic Processes