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Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population

Primary Purpose

Abscess, Drain Abscess

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
incision and loop drainage
traditional incision and drainage (I&D)
Sponsored by
bryan malcolm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring Emergency Medicine, Abscess, Incision and Drainage, Incision and Loop Drainage, Sterile Glove

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

  • Active Duty and DoD beneficiaries aged 18 to 65 years old.
  • Abscess that requires drainage.

Exclusion Criteria:

  • Abscess of the hand, foot, or face, immunocompromised by disease or medications.
  • Temperature greater than 100.4 degrees Fahrenheit.
  • Systolic blood pressure less than 90 mmHG.
  • Abscess is too small to treat with incision and drainage (as seen on ultrasound).
  • Patient is too ill to be included in the study determined by clinical judgement of the treating provider.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    traditional incision and drainage (I&D)

    incision and loop drainage

    Arm Description

    incision and loop drainage utilizing the rolled ring of a sterile glove technique

    Outcomes

    Primary Outcome Measures

    Number of subjects with Treatment effectiveness
    A record review will be performed to identify patients that had to return to the Emergency Department up to 30 days after the procedure due to complications. Attempts will be made to contact patients who fail to follow up. If unable to contact, a record review will be conducted in attempt to ascertain abscess status. If these measures are unsuccessful, patient treatment will be considered a success. Record Review: Treatment failure will be defined as need for repeat drainage, intravenous antibiotic, hospitalization or surgical treatment within 7 days.
    Subject pain: Visual Analogue Scale
    Data will be collected using the VAS. Patients mark will be measured in millimeters and recorded. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Lower scores mean a better outcome and higher scores mean greater pain severity.
    Provider satisfaction: Visual Analogue Scale
    Data will be collected using the VAS. Provider mark will be measured in millimeters and recorded. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
    Subject satisfaction: Visual Analogue Scale
    Data will be collected using the VAS. Subject mark will be measured in millimeters and recorded. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 22, 2020
    Last Updated
    February 3, 2021
    Sponsor
    bryan malcolm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04241471
    Brief Title
    Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population
    Official Title
    Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study published rendering this protocol/study obsolete.
    Study Start Date
    May 4, 2020 (Actual)
    Primary Completion Date
    February 2, 2021 (Actual)
    Study Completion Date
    February 2, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    bryan malcolm

    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
    When using the rolled ring of a sterile glove as a loop drain in incision and loop drainage, is it superior to incision and drainage for treatment of a cutaneous abscess in 18 to 65 year-old patients presenting to the Emergency Department, Family Health Clinic, Family Medicine Residency Clinic, or Internal Medicine Clinic? Hypothesis: When treating a cutaneous abscess, incision and loop drainage utilizing the rolled ring of a sterile glove as a loop drain is superior to the standard (incision and drainage) yielding a treatment failure rate of 1% at seven to ten days.
    Detailed Description
    Practicing medicine in an austere environment is fraught with challenges. One primary challenge is that clinicians will frequently be practicing without the supplies needed for specific indicated purpose. For treatment of a cutaneous abscess, sterile gloves are readily available whether at home or when deployed. It can be much more difficult to come across a penrose or vessel loop. In addition, follow up for wound repacking and reassessment is a struggle. Patients may have to move from location to location or have work hours that make it difficult to return to the clinic. The loop technique utilizing the rolled ring of a sterile glove solves both of these problems. Sterile gloves are always available and the Loop technique requires little to no follow up. Additional benefits include: subjects may experience less pain, improved cosmesis, faster healing, and decreased complication rates with incision and loop drainage utilizing the rolled ring of a sterile glove compared to traditional incision and drainage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abscess, Drain Abscess
    Keywords
    Emergency Medicine, Abscess, Incision and Drainage, Incision and Loop Drainage, Sterile Glove

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    traditional incision and drainage (I&D)
    Arm Type
    Active Comparator
    Arm Title
    incision and loop drainage
    Arm Type
    Experimental
    Arm Description
    incision and loop drainage utilizing the rolled ring of a sterile glove technique
    Intervention Type
    Procedure
    Intervention Name(s)
    incision and loop drainage
    Intervention Description
    incision and loop drainage utilizing the rolled ring of a sterile glove technique
    Intervention Type
    Device
    Intervention Name(s)
    traditional incision and drainage (I&D)
    Intervention Description
    traditional incision and drainage (I&D)
    Primary Outcome Measure Information:
    Title
    Number of subjects with Treatment effectiveness
    Description
    A record review will be performed to identify patients that had to return to the Emergency Department up to 30 days after the procedure due to complications. Attempts will be made to contact patients who fail to follow up. If unable to contact, a record review will be conducted in attempt to ascertain abscess status. If these measures are unsuccessful, patient treatment will be considered a success. Record Review: Treatment failure will be defined as need for repeat drainage, intravenous antibiotic, hospitalization or surgical treatment within 7 days.
    Time Frame
    30 days post-procedure
    Title
    Subject pain: Visual Analogue Scale
    Description
    Data will be collected using the VAS. Patients mark will be measured in millimeters and recorded. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Lower scores mean a better outcome and higher scores mean greater pain severity.
    Time Frame
    Pre-procedure, mid-procedure, post-procedure
    Title
    Provider satisfaction: Visual Analogue Scale
    Description
    Data will be collected using the VAS. Provider mark will be measured in millimeters and recorded. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
    Time Frame
    post-procedure
    Title
    Subject satisfaction: Visual Analogue Scale
    Description
    Data will be collected using the VAS. Subject mark will be measured in millimeters and recorded. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
    Time Frame
    7-10 day follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    **Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Active Duty and DoD beneficiaries aged 18 to 65 years old. Abscess that requires drainage. Exclusion Criteria: Abscess of the hand, foot, or face, immunocompromised by disease or medications. Temperature greater than 100.4 degrees Fahrenheit. Systolic blood pressure less than 90 mmHG. Abscess is too small to treat with incision and drainage (as seen on ultrasound). Patient is too ill to be included in the study determined by clinical judgement of the treating provider.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul F Crawford, MD
    Organizational Affiliation
    United States Air Force
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not plan on sharing data.
    Citations:
    PubMed Identifier
    28069270
    Citation
    Aprahamian CJ, Nashad HH, DiSomma NM, Elger BM, Esparaz JR, McMorrow TJ, Shadid AM, Kao AM, Holterman MJ, Kanard RC, Pearl RH. Treatment of subcutaneous abscesses in children with incision and loop drainage: A simplified method of care. J Pediatr Surg. 2017 Sep;52(9):1438-1441. doi: 10.1016/j.jpedsurg.2016.12.018. Epub 2016 Dec 30.
    Results Reference
    background
    PubMed Identifier
    30661820
    Citation
    Brody AM, Gallien J, Murphy D, Marogil J. A Novel Silicon Device for the Packing of Cutaneous Abscesses. J Emerg Med. 2019 Mar;56(3):298-300. doi: 10.1016/j.jemermed.2018.12.009. Epub 2019 Jan 17.
    Results Reference
    background
    PubMed Identifier
    28917436
    Citation
    Gottlieb M, Peksa GD. Comparison of the loop technique with incision and drainage for soft tissue abscesses: A systematic review and meta-analysis. Am J Emerg Med. 2018 Jan;36(1):128-133. doi: 10.1016/j.ajem.2017.09.007. Epub 2017 Sep 10.
    Results Reference
    background
    PubMed Identifier
    25435407
    Citation
    Ladde JG, Baker S, Rodgers CN, Papa L. The LOOP technique: a novel incision and drainage technique in the treatment of skin abscesses in a pediatric ED. Am J Emerg Med. 2015 Feb;33(2):271-6. doi: 10.1016/j.ajem.2014.10.014. Epub 2014 Oct 16.
    Results Reference
    background
    PubMed Identifier
    24074675
    Citation
    Leinwand M, Downing M, Slater D, Beck M, Burton K, Moyer D. Incision and drainage of subcutaneous abscesses without the use of packing. J Pediatr Surg. 2013 Sep;48(9):1962-5. doi: 10.1016/j.jpedsurg.2013.01.027.
    Results Reference
    background
    PubMed Identifier
    29530657
    Citation
    Long B, April MD. Is Loop Drainage Technique More Effective for Treatment of Soft Tissue Abscess Compared With Conventional Incision and Drainage? Ann Emerg Med. 2019 Jan;73(1):19-21. doi: 10.1016/j.annemergmed.2018.02.006. Epub 2018 Mar 9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21376200
    Citation
    McNamara WF, Hartin CW Jr, Escobar MA, Yamout SZ, Lau ST, Lee YH. An alternative to open incision and drainage for community-acquired soft tissue abscesses in children. J Pediatr Surg. 2011 Mar;46(3):502-6. doi: 10.1016/j.jpedsurg.2010.08.019.
    Results Reference
    background
    PubMed Identifier
    28162873
    Citation
    Ozturan IU, Dogan NO, Karakayali O, Ozbek AE, Yilmaz S, Pekdemir M, Suner S. Comparison of loop and primary incision & drainage techniques in adult patients with cutaneous abscess: A preliminary, randomized clinical trial. Am J Emerg Med. 2017 Jun;35(6):830-834. doi: 10.1016/j.ajem.2017.01.036. Epub 2017 Jan 22.
    Results Reference
    background
    PubMed Identifier
    32406569
    Citation
    Schechter-Perkins EM, Dwyer KH, Amin A, Tyler MD, Liu J, Nelson KP, Mitchell PM. Loop Drainage Is Noninferior to Traditional Incision and Drainage of Cutaneous Abscesses in the Emergency Department. Acad Emerg Med. 2020 Nov;27(11):1150-1157. doi: 10.1111/acem.13981. Epub 2020 May 14.
    Results Reference
    background
    PubMed Identifier
    24928539
    Citation
    Thompson DO. Loop drainage of cutaneous abscesses using a modified sterile glove: a promising technique. J Emerg Med. 2014 Aug;47(2):188-91. doi: 10.1016/j.jemermed.2014.04.035. Epub 2014 Jun 11.
    Results Reference
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    PubMed Identifier
    20223328
    Citation
    Tsoraides SS, Pearl RH, Stanfill AB, Wallace LJ, Vegunta RK. Incision and loop drainage: a minimally invasive technique for subcutaneous abscess management in children. J Pediatr Surg. 2010 Mar;45(3):606-9. doi: 10.1016/j.jpedsurg.2009.06.013.
    Results Reference
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    PubMed Identifier
    30126754
    Citation
    Gaspari RJ, Sanseverino A, Gleeson T. Abscess Incision and Drainage With or Without Ultrasonography: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jan;73(1):1-7. doi: 10.1016/j.annemergmed.2018.05.014. Epub 2018 Aug 17.
    Results Reference
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    Links:
    URL
    https://baylor.primo.exlibrisgroup.com/discovery/fulldisplay?docid=wos000445699100183&context=PC&vid=01BUL_INST:BAYLOR&lang=en&search_scope=MyInst_and_CI&adaptor=Primo%20Central&tab=Everything&query=any,contains,incision%20and%20loop%20drainage&offset=0.
    Description
    loop drainage

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    Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population

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