NCT04241471

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

January 22, 2020

Last Update Submit

September 3, 2024

Conditions

AbscessDrain Abscess

Keywords

Emergency MedicineAbscessIncision and DrainageIncision and Loop DrainageSterile Glove

Outcome Measures

Primary Outcomes (4)

  • 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.

    30 days post-procedure

  • 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.

    Pre-procedure, mid-procedure, post-procedure

  • 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.

    post-procedure

  • 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.

    7-10 day follow-up

Study Arms (2)

traditional incision and drainage (I&D)

ACTIVE COMPARATOR
Device: traditional incision and drainage (I&D)

incision and loop drainage

EXPERIMENTAL

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

Procedure: incision and loop drainage

Interventions

incision and loop drainagePROCEDURE

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

incision and loop drainage
traditional incision and drainage (I&D)DEVICE

traditional incision and drainage (I\&D)

traditional incision and drainage (I&D)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 28069270BACKGROUND

  • 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.

    PMID: 30661820BACKGROUND

  • 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.

    PMID: 28917436BACKGROUND

  • 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.

    PMID: 25435407BACKGROUND

  • 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.

    PMID: 24074675BACKGROUND

  • 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.

    PMID: 29530657BACKGROUND

  • 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.

    PMID: 21376200BACKGROUND

  • 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.

    PMID: 28162873BACKGROUND

  • 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.

    PMID: 32406569BACKGROUND

  • 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.

    PMID: 24928539BACKGROUND

  • 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.

    PMID: 20223328BACKGROUND

  • 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.

    PMID: 30126754BACKGROUND

Related Links

MeSH Terms

Conditions

AbscessSurgical Wound

Interventions

Drainage

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Paul F Crawford, MD

    United States Air Force

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

May 4, 2020

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

We do not plan on sharing data.