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Trial of Abscess Drainage Techniques

Primary Purpose

Cutaneous Abscess

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vessel loop
traditional I&D with or without packing
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Abscess focused on measuring traditional incision and drainage, minimally invasive incision and drainage, vessel loop, emergency department, pediatrics

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pediatric patient (0-18 years old) with abscess over 3 cm which can be drained in the ER and does not require hospitalization

Exclusion Criteria:

  • Diabetes
  • immunocompromised
  • cancer
  • chemotherapy
  • requires hospitalization for treatment of abscess
  • abscess felt not drainable in the ER by ER physicians

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Traditional

    Minimally Invasive

    Arm Description

    cutaneous abscess with be opened in the traditional incision and drainage technique with large incision, breaking up of pockets of pus, washing out the pocket and with or without packing gauze placed into residual cavity

    Cutaneous abscess will be opened with two small incisions just large enough to pass a vessel loop through both to keep them open. Pockets of pus will be broken up and the cavity washed out before placing the loop through both incisions and loosely tieing it over the skin

    Outcomes

    Primary Outcome Measures

    number of patients who require repeat I&D collected by data form
    any patient that needs an additional I&D procedure noted on data collection forms
    Number of patients who Need to have an antibiotic added to treatment plan/or changed antibiotic after the initial visit collected by data form
    any patient requiring the above noted on data collection forms
    the number of patients who need to be hospitalized after the first visit collected by data form
    if patient is hospitalized after first visit, as collected on data form

    Secondary Outcome Measures

    patient satisfaction with procedure collected by survey
    1-100 scale of satisfaction survey with the drainage performed
    patient satisfaction with healing of abscess collected by survey
    1-100 scale survey of how satisfied patient is with how the drainage site healed
    patient satisfaction with overall treatment of the abscess collected by survey
    1-100 scale survey for how satisfied patient is with overall care related to abscess

    Full Information

    First Posted
    July 29, 2015
    Last Updated
    February 19, 2019
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02545946
    Brief Title
    Trial of Abscess Drainage Techniques
    Official Title
    Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Control Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    June 24, 2016 (Actual)
    Study Completion Date
    July 7, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparing the outcome of traditional incision and drainage with a larger skin incision with or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive incision and drainage with two small incisions and a vessel loop transversing the incisions to keep them open.
    Detailed Description
    This prospective randomized single blind clinical trial will be conducted in a suburban pediatric emergency department that treats approximately 29,000 patients per year. Patients between 0-17 years with a superficial skin or soft tissue abscess larger than 3 cm that would be appropriate for ED I&D and outpatient management will be screened for inclusion. Patients will be excluded if they are immunocompromised (taking chemotherapy, steroid or bioactive medications or having diabetes mellitus), require a subspecialist for drainage or require hospitalization. Subjects will be required to provide assent when age-appropriate, and parental consent will be obtained. The parent or guardian will need to be in the emergency department with the child to provide consent. Subjects will be randomized to be in either the traditional I&D arm or the minimally invasive vessel loop arm using numbered sealed envelops. Computer blocking will randomize these numbered envelopes. Inside the envelope there will be instructions to the treating physician as to which of two standard techniques should be employed. Standardized I&D will be performed with a #11 blade scalpel and a full thickness cut incising the lesion along at least 50% of the abscess diameter. The pocket will then be probed to break up septations and the residual cavity will be irrigated with normal saline. Iodinated gauze 0.25 inch will be used to loosely pack the remaining cavity if the physician deems packing is necessary. The gauze will be left trailing out of the surgical incision. The abscess will then be covered with 4 X 4 dry gauze and taped in place. Minimally invasive I&D with vessel loop will be preformed by making a 5mm incision with a #11 blade in the area of maximal fluctuance. The cavity will then be probed with forceps breaking up any septations. The forceps will then be used to find the furthest extent of the cavity, and the #11 blade will be used to make a 5mm incision at the tip of the forceps (at the farthest extent of the cavity). The forceps will then be pushed through this second incision. The vessel loop will be grasped by the forceps and then pulled back through both surgical incisions. The vessel loop will then be tied loosely together, creating a loop back through both surgical incisions. Both sides of the incisions will then be irrigated with normal saline. Cultures will be obtained, if possible, from the abscess. Pain medication and sedation at the time of the I&D will be left to the discretion of the treating physician. Antibiotics will not be mandated, but allowed at the judgment of the treating medical team. All subjects will be given 2 prescriptions for analgesia at home. One for mild pain, ibuprofen; another for moderate or severe pain, acetaminophen with hydrocodone (either liquid or pills) will be given. Equipotent alternatives will be provided in case of medication allergy. Pain scores will be assessed using a ten point scale before and after the procedure and at 48 hour follow up. Data recorded at the first visit will include demographics (age, male/female), characteristics of the abscess, fever, duration of symptoms, history of prior abscess, antibiotics in the last month, and provision of antibiotics post-procedure. All subjects will return to the ER in 72 hours and 1 week for a recheck. At the 3rd day visit, wound packing will be removed. Large cavities will be repacked at the discretion of the ED physician. Loops will be cut and removed at the 7th day visit unless significant cellulitis remains. If cellulitis remains after 7 days, additional visits/hospitalization would be set up at the treating doctors discretion. Given that failure of treatment is a possible event in any abscess drainage, even those not involved with this study, hospitalization or additional visits beyond the 2 included in the study, will be billed to the patient's family and/or insurance company as any visit to the ER or hospital admission. Patients and families will also be contacted at one month via telephone interview. Self-rated cosmetic outcome will be assessed using a 10 point scale from worst to best looking scar.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cutaneous Abscess
    Keywords
    traditional incision and drainage, minimally invasive incision and drainage, vessel loop, emergency department, pediatrics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Traditional
    Arm Type
    Active Comparator
    Arm Description
    cutaneous abscess with be opened in the traditional incision and drainage technique with large incision, breaking up of pockets of pus, washing out the pocket and with or without packing gauze placed into residual cavity
    Arm Title
    Minimally Invasive
    Arm Type
    Active Comparator
    Arm Description
    Cutaneous abscess will be opened with two small incisions just large enough to pass a vessel loop through both to keep them open. Pockets of pus will be broken up and the cavity washed out before placing the loop through both incisions and loosely tieing it over the skin
    Intervention Type
    Device
    Intervention Name(s)
    vessel loop
    Intervention Description
    using the vessel loop to hold the place of the surgical wound that is made during I&D
    Intervention Type
    Other
    Intervention Name(s)
    traditional I&D with or without packing
    Intervention Description
    abscess will be drained with a traditional I&D with or without packing (as deemed appropriate by ER doctor)
    Primary Outcome Measure Information:
    Title
    number of patients who require repeat I&D collected by data form
    Description
    any patient that needs an additional I&D procedure noted on data collection forms
    Time Frame
    1 week
    Title
    Number of patients who Need to have an antibiotic added to treatment plan/or changed antibiotic after the initial visit collected by data form
    Description
    any patient requiring the above noted on data collection forms
    Time Frame
    1 week
    Title
    the number of patients who need to be hospitalized after the first visit collected by data form
    Description
    if patient is hospitalized after first visit, as collected on data form
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    patient satisfaction with procedure collected by survey
    Description
    1-100 scale of satisfaction survey with the drainage performed
    Time Frame
    1 day
    Title
    patient satisfaction with healing of abscess collected by survey
    Description
    1-100 scale survey of how satisfied patient is with how the drainage site healed
    Time Frame
    1 month
    Title
    patient satisfaction with overall treatment of the abscess collected by survey
    Description
    1-100 scale survey for how satisfied patient is with overall care related to abscess
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pediatric patient (0-18 years old) with abscess over 3 cm which can be drained in the ER and does not require hospitalization Exclusion Criteria: Diabetes immunocompromised cancer chemotherapy requires hospitalization for treatment of abscess abscess felt not drainable in the ER by ER physicians
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Milan Nadkarni, MD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Trial of Abscess Drainage Techniques

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