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Comparison of Loop Drainage Versus Incision and Drainage for Abscesses in Children

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ClinicalTrials.gov Identifier: NCT02443272
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Scientific, Education and Research Foundation of UTSW Austin
Information provided by (Responsible Party):
Seton Healthcare Family

Brief Summary:
The purpose of this study is to compare abscess drainage utilizing the vessel loop technique in children to the standard incision and drainage technique with the endpoint to determine if rates of treatment failure are non-inferior.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison Study of Minimally Invasive Loop Drainage Versus Standard Incision and Drainage for Skin Abscesses in Children
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Active Comparator: Control Arm
Receive standard incision and drainage
Procedure: Incision and Drainage
Standard of care treatment will utilize incision and drainage over the center of the abscess cavity with or without packing at physicians discretion.

Experimental: Intervention Arm
Receive minimal invasive loop drainage using the Vesi-loop device
Procedure: Vessel Loop Drainage
Minimally invasive approach will utilize a vesi-loop device for the vessel loop drainage technique by placing 2 peripheral stab incisions into the abscess with a tunnel through the abscess cavity, and loop passed through the tunnel and tied atop the skin.




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: 14 days ]
    Requiring reinstrumentation of abscess, or hospital admission for IV antibiotics


Secondary Outcome Measures :
  1. Parental satisfaction with procedure [ Time Frame: 1 Day ]
    Likert Scale of 1-5

  2. Physician satisfaction with procedure [ Time Frame: 1 Day ]
    Likert Scale of 1-5

  3. Level of anxiety with wound care at home [ Time Frame: 14 Days ]
    Likert Scale of 1-5

  4. Level of simplicity with wound care at home [ Time Frame: 14 Days ]
    Likert Scale of 1-5

  5. Cosmetic success [ Time Frame: 14 Days ]
    Hollander scale evaluating wound margins for step off, irregularity, wide separation, inversion

  6. Parental satisfaction with scar [ Time Frame: 90 Days ]
    Likert Scale of 1-5

  7. Pain reduction with drainage procedure [ Time Frame: 1 Day ]
    Revised FACES scale of 0-10

  8. Frequency of post-drainage visits to a physician [ Time Frame: 14 Days ]
    Any return for follow-up, packing removal, failure to improve, or any concern



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physical findings suggestive of skin abscess warranting incision and drainage (determined by treating physician)

Exclusion Criteria:

  • Abscess not suitable for drainage in the ED (eg. <1 cm induration, >15 cm induration)
  • Immunocompromised status (eg. diabetic patient or taking immunosuppressive medication)
  • Need for hospitalization following drainage
  • Abscess located above the clavicles or significantly involving genitals/pilonidal region
  • Previous instrumentation to the abscess
  • Primary language not English or Spanish
  • High probability of loss to follow up (parent does not commit to both mandatory follow up appointments)

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): NCT02443272


Locations
United States, Texas
Dell Children's Medical Center
Austin, Texas, United States, 78723
Sponsors and Collaborators
Seton Healthcare Family
Scientific, Education and Research Foundation of UTSW Austin
Investigators
Principal Investigator: Logan R Rencher, DO UT-Austin Dell Children's Medical Center PEM Fellowship

Publications:

Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT02443272     History of Changes
Other Study ID Numbers: CR-14-114
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Abscess
Skin Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs