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Abscess Aspiration

Primary Purpose

Skin Abscess

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided Needle Aspiration Procedure
Incision and Drainage (I&D)
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Abscess focused on measuring Ultrasound Guided Needle Aspiration, Incision and Drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Non-toxic patients who present with an uncomplicated, superficial skin abscess of the head/neck, torso, extremities, and buttock will be eligible for inclusion.
  2. Abscesses must be verified by physical examination and bedside ultrasound.
  3. Patients with clinical history of diabetes mellitus and previous diagnosis of MRSA will be included.

Exclusion Criteria:

  1. Patients will be excluded if age less than age 18 or pregnant.
  2. Patient or legal guardian is unable to give consent.
  3. Patients with no means of clinical follow-up will be excluded.
  4. Complicated abscesses, defined as an abscess with associated sepsis, lymphangitis, or osteomyelitis, requiring intravenous antibiotic therapy, requiring hospital admission, previous surgical drainage at site of abscess, overlying skin lesion/fistula/ulceration with the exception of cellulitis, perforated or actively draining abscess, duration of symptoms > 5 days,1,28 and/or multiple concurrent abscesses that can be clinically regarded as chronic in nature will be excluded.

4) Abscess locations which will be excluded are dental, peritonsillar, anorectal, genital/inguinal, axillary if suspicion for chronic hidradenitis suppurativa, or pilonidal/intragluteal at the base of the coccyx.

5) Abscesses greater in size than 3x3x3 cm in any dimension will be excluded. [It has been suggested extensively in the surgical literature that an abscess diameter >3 cm should have surgical/catheter-drainage as the initial management instead of needle aspiration]2,5,15,19,27,33 [It has been reported that abscesses >3 cm in size have increased failure rates]15 6) Abscess depth is greater than maximal needle length. 7) Patients with immunosuppression from following clinical conditions will be excluded: HIV, cancer on active chemotherapy.

8) Patients with active history of IV drug use will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Surgical I&D Procedure

    Ultrasound-guided Needle Aspiration Procedure

    Arm Description

    The abscess cavity will be evaluated thoroughly with ultrasonography. The site will be prepared and draped. The skin surface will be infiltrated with local anesthetic with a 25-gauge needle. The treating clinician may provide ultrasound-guided regional anesthesia for procedural analgesia at their discretion. Incision of the skin surface with a number 11-blade scalpel will be performed over the largest area of infection; the incision will be extended into the abscess cavity. A blunt instrument will then be used to break up internal loculations if present. Repeated instrumentation through the initial incision or extension of the original incision will be performed if needed. Lastly, iodoform packing will be inserted through the incision into the cavity. The decision to send the abscess contents for microbiological culture and susceptibility analysis will be at the discretion of the treating clinician.

    The abscess cavity will be evaluated thoroughly with US. The site will be prepared and draped. The skin surface and anticipated needle track will be infiltrated with local anesthetic with a 25g needle. The treating clinician may provide ultrasound-guided regional anesthesia for procedural analgesia at their discretion. Under direct US-guided visualization, a 14g 2in steel needle attached to a 40mL syringe will be advanced into the abscess cavity with manual negative pressure. The needle tract will be extended obliquely 2-3 cm between the skin and abscess to prevent fistulization. Purulent material will be aspirated until no further purulence can be aspirated. Multiple aspiration attempts on the initial visit will be permitted to maximally drain the abscess cavity. Additionally, irrigation of the abscess cavity with sterile saline will be permitted to break up internal loculations if present, as has reported previously for trunk and breast abscesses.

    Outcomes

    Primary Outcome Measures

    Abscess cure or treatment failure
    Treatment cure will be defined by the complete resolution of the abscess based on clinical signs and symptoms (no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance, or induration) at the 7- to 10-day follow-up. Treatment failure will be defined by: fever (attributable to the infection), persistent or increased size >25% of the original abscess, requiring conversion to I&D (USGNA intervention group) or repeat I&D (I&D intervention group), requiring additional antibiotics, or requiring hospital admission within 7-10 days after treatment. Participants who either withdraw from the trial or are lost to follow-up before a determination of final outcome will be classified as treatment failure.

    Secondary Outcome Measures

    Patient Satisfaction
    Patient satisfaction with each procedural intervention will be assessed, with the hypothesis that USGNA will have higher overall satisfaction rates than I&D.
    Patient Comfort Level
    Patient comfort for each procedural intervention will be assessed , with the hypothesis that USGNA will have lower overall pain scores compared to I&D.
    Abscess Characteristics and Correlation with Treatment Failure
    Assessment of whether specific abscess characteristics have any correlation to procedural failure in either intervention group.
    Abscess Reoccurrence
    The cumulative rate of abscess recurrence will be assessed at the 21- to 30-day follow-up.
    Abscess Site infection
    Infections involving the same site at the 21- to 30-day follow-up will be considered a recurrent infection.

    Full Information

    First Posted
    October 10, 2019
    Last Updated
    May 18, 2020
    Sponsor
    Wayne State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04127071
    Brief Title
    Abscess Aspiration
    Official Title
    Study Protocol for A Randomized Controlled Trial of Incision and Drainage Versus Ultrasound-Guided Needle Aspiration for Uncomplicated Skin Abscesses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wayne State University

    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
    Incision and drainage (I&D) is the standard guideline treatment of uncomplicated skin abscesses (a boil or bumo beneath the skin). Ultrasound-guided needle aspiration (USGNA) is a minimally invasive and less painful alternative treatment, but has not been validated as non-inferior to I&D. Multiple studies have shown successful treatment with USGNA of breast, face, neck, and/or trunk abscesses in combination with oral antibiotics with success rates as high as 97%. In 2011 Gaspari et al. published a landmark article on the use of USGNA for skin abscesses. In this randomized controlled trial, USGNA and I&D had failure rates of 74% and 20% respectively, which makes USGNA an unappealing treatment option. However, the study had several methodological issues that likely biased the results in favor of I&D, including the following: 1) aspiration was performed with an 18-gauge needle which is often too small to aspirate thick purulence (or pus); 2) failure to fully aspirate all abscess contents was a priori defined as treatment failure rather than strictly clinical outcomes; 3) the abscess aspiration procedure was not standardized; and 4) post-intervention oral antibiotic therapy was not used on all patients. The main hypothesis is that a modified protocol of the Gaspari et al. USGNA study to address these flaws will demonstrate a failure of USGNA comparable to I&D for the treatment of uncomplicated skin abscesses. First, the study will standardize the use of larger 14-gauge needle on all USGNAs. Second, USGNA intervention failure need not be defined as the inability to completely aspirate all abscess cavity contents under ultrasound guidance. Previous studies have demonstrated clinical success with USGNA of skin abscesses without applying the rigid failure criteria chosen by Gaspari et al. There is only one study in the literature to suggest that there is no correlation between a small quantity of residual abscess contents post-USGNA and ultimate clinical failure, however, there are no studies which specifically address this clinical question. In this study, initial treatment failure of USGNA will be defined as the inability to aspirate any purulent material. Third, treatment outcomes in this study will be determined by clinical resolution of abscess at the study endpoint of 7-10 days, which is a well-established timeline for anticipated abscess healing and endpoint clinical follow-up. Fourth, ultrasound fellowship-trained emergency physicians will perform USGNA in standardized fashion on all enrolled patients. Lastly, post-intervention oral antibiotic with methicillin-resistant Staphylococcus aureus (MRSA) coverage will be provided and compliance closely monitored throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Abscess
    Keywords
    Ultrasound Guided Needle Aspiration, Incision and Drainage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A prospective, nonblinded, randomized controlled trial comparing ultrasound-guided needle aspiration to incision and drainage of uncomplicated skin abscesses.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgical I&D Procedure
    Arm Type
    Active Comparator
    Arm Description
    The abscess cavity will be evaluated thoroughly with ultrasonography. The site will be prepared and draped. The skin surface will be infiltrated with local anesthetic with a 25-gauge needle. The treating clinician may provide ultrasound-guided regional anesthesia for procedural analgesia at their discretion. Incision of the skin surface with a number 11-blade scalpel will be performed over the largest area of infection; the incision will be extended into the abscess cavity. A blunt instrument will then be used to break up internal loculations if present. Repeated instrumentation through the initial incision or extension of the original incision will be performed if needed. Lastly, iodoform packing will be inserted through the incision into the cavity. The decision to send the abscess contents for microbiological culture and susceptibility analysis will be at the discretion of the treating clinician.
    Arm Title
    Ultrasound-guided Needle Aspiration Procedure
    Arm Type
    Experimental
    Arm Description
    The abscess cavity will be evaluated thoroughly with US. The site will be prepared and draped. The skin surface and anticipated needle track will be infiltrated with local anesthetic with a 25g needle. The treating clinician may provide ultrasound-guided regional anesthesia for procedural analgesia at their discretion. Under direct US-guided visualization, a 14g 2in steel needle attached to a 40mL syringe will be advanced into the abscess cavity with manual negative pressure. The needle tract will be extended obliquely 2-3 cm between the skin and abscess to prevent fistulization. Purulent material will be aspirated until no further purulence can be aspirated. Multiple aspiration attempts on the initial visit will be permitted to maximally drain the abscess cavity. Additionally, irrigation of the abscess cavity with sterile saline will be permitted to break up internal loculations if present, as has reported previously for trunk and breast abscesses.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided Needle Aspiration Procedure
    Intervention Description
    The intervention under investigation utilizes an ultrasound-guided needle to less invasively drain an abscess.
    Intervention Type
    Procedure
    Intervention Name(s)
    Incision and Drainage (I&D)
    Intervention Description
    The current standard procedure to drain an abscess of purulent material.
    Primary Outcome Measure Information:
    Title
    Abscess cure or treatment failure
    Description
    Treatment cure will be defined by the complete resolution of the abscess based on clinical signs and symptoms (no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance, or induration) at the 7- to 10-day follow-up. Treatment failure will be defined by: fever (attributable to the infection), persistent or increased size >25% of the original abscess, requiring conversion to I&D (USGNA intervention group) or repeat I&D (I&D intervention group), requiring additional antibiotics, or requiring hospital admission within 7-10 days after treatment. Participants who either withdraw from the trial or are lost to follow-up before a determination of final outcome will be classified as treatment failure.
    Time Frame
    7-10 days
    Secondary Outcome Measure Information:
    Title
    Patient Satisfaction
    Description
    Patient satisfaction with each procedural intervention will be assessed, with the hypothesis that USGNA will have higher overall satisfaction rates than I&D.
    Time Frame
    Baseline (Day 1)
    Title
    Patient Comfort Level
    Description
    Patient comfort for each procedural intervention will be assessed , with the hypothesis that USGNA will have lower overall pain scores compared to I&D.
    Time Frame
    Baseline (Day 1)
    Title
    Abscess Characteristics and Correlation with Treatment Failure
    Description
    Assessment of whether specific abscess characteristics have any correlation to procedural failure in either intervention group.
    Time Frame
    Baseline (Day 1)
    Title
    Abscess Reoccurrence
    Description
    The cumulative rate of abscess recurrence will be assessed at the 21- to 30-day follow-up.
    Time Frame
    Day 21-30
    Title
    Abscess Site infection
    Description
    Infections involving the same site at the 21- to 30-day follow-up will be considered a recurrent infection.
    Time Frame
    Day 21-30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-toxic patients who present with an uncomplicated, superficial skin abscess of the head/neck, torso, extremities, and buttock will be eligible for inclusion. Abscesses must be verified by physical examination and bedside ultrasound. Patients with clinical history of diabetes mellitus and previous diagnosis of MRSA will be included. Exclusion Criteria: Patients will be excluded if age less than age 18 or pregnant. Patient or legal guardian is unable to give consent. Patients with no means of clinical follow-up will be excluded. Complicated abscesses, defined as an abscess with associated sepsis, lymphangitis, or osteomyelitis, requiring intravenous antibiotic therapy, requiring hospital admission, previous surgical drainage at site of abscess, overlying skin lesion/fistula/ulceration with the exception of cellulitis, perforated or actively draining abscess, duration of symptoms > 5 days,1,28 and/or multiple concurrent abscesses that can be clinically regarded as chronic in nature will be excluded. 4) Abscess locations which will be excluded are dental, peritonsillar, anorectal, genital/inguinal, axillary if suspicion for chronic hidradenitis suppurativa, or pilonidal/intragluteal at the base of the coccyx. 5) Abscesses greater in size than 3x3x3 cm in any dimension will be excluded. [It has been suggested extensively in the surgical literature that an abscess diameter >3 cm should have surgical/catheter-drainage as the initial management instead of needle aspiration]2,5,15,19,27,33 [It has been reported that abscesses >3 cm in size have increased failure rates]15 6) Abscess depth is greater than maximal needle length. 7) Patients with immunosuppression from following clinical conditions will be excluded: HIV, cancer on active chemotherapy. 8) Patients with active history of IV drug use will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Ehrman, MD
    Phone
    3139932530
    Email
    rehrman@med.wayne.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Ehrman, MD
    Organizational Affiliation
    Wayne State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Abscess Aspiration

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