Loop Drainage: Effectiveness in Treating Cutaneous Abscesses

NCT02697279 | Terminated DMC

• 1 other identifier: HP-00066974
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I\&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Additionally, compliance with wound care and follow-up can present barriers to proper care and healing. Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess. Thus far, research into this procedure has been limited to the pediatric population with small sample sizes. In these previous studies, this technique was found to be an effective and less painful treatment for abscesses. Research has not been done in the adult population using this procedure. If this procedure is found to be as effective and less painful in the adult population, then it should be considered as a potential preferred I\&D method for cutaneous abscess in the ED.

Conditions

Abscess of Skin and/or Subcutaneous Tissue

Keywords

Abscess; Loop; Drainage

Outcome Measures

Primary Outcomes (1)

• Procedure failure rate

  Determining the difference in failure rates between the study group and control group. Treatment failure is a composite outcome defined as having the presence of any of the following: requiring a 2nd incision and drainage procedure, a patient that requires administration of antibiotics after the initial treatment period due to worsening clinical status, a patient that requires hospitalization after the initial treatment period due to worsening clinical status.

  5 -7 days after procedure

Secondary Outcomes (2)

• Difference in pain associated with the procedure using a visual analog pain scale

  Measured after the procedure on day 1

• Patient Satisfaction using a visual analog pain scale

  5-7 days after procedure

Study Arms (2)

Traditional Incision and Drainage

ACTIVE COMPARATOR

Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider.

Procedure: Traditional Incision and Drainage.

Loop drainage

EXPERIMENTAL

Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique.

Procedure: Loop drainage

Interventions

Traditional Incision and Drainage. PROCEDURE

Control Group- Standard treatment of a simple cutaneous abscess with traditional I\&D technique with or without packing utilizing a standard I\&D kit.

Traditional Incision and Drainage

Loop drainage PROCEDURE

Study Group- Treatment of a simple cutaneous abscess with the loop drainage technique utilizing an standard I\&D kit and the cuff of a sterile glove for a loop device.

Loop drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Presents to ED with simple cutaneous abscess
• Provides informed consent.

You may not qualify if:

• Under 18 years of age
• Abscess too small for performance of procedure
• Signs of systemic infection
• Need for hospitalization
• Previously treated for current abscess
• Clinician determines abscess would not be amenable to drainage by loop technique
• Patients known to be pregnant
• Incarcerated patients
• Students / Employees of the facility

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

Related Publications (7)

• Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg. 2010 Jul;45(7):1562-6. doi: 10.1016/j.jpedsurg.2010.03.025.

  PMID: 20638546 BACKGROUND

• Kushnir VA, Mosquera C. Novel technique for management of Bartholin gland cysts and abscesses. J Emerg Med. 2009 May;36(4):388-90. doi: 10.1016/j.jemermed.2008.05.019. Epub 2008 Nov 26.

  PMID: 19038518 BACKGROUND

• 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: 25435407 BACKGROUND

• 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: 24928539 BACKGROUND

• 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: 21376200 BACKGROUND

• 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: 20223328 BACKGROUND

• Taira BR, Singer AJ, Thode HC Jr, Lee CC. National epidemiology of cutaneous abscesses: 1996 to 2005. Am J Emerg Med. 2009 Mar;27(3):289-92. doi: 10.1016/j.ajem.2008.02.027.

  PMID: 19328372 BACKGROUND

MeSH Terms

Conditions

Abscess

Interventions

Drainage

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• R. Gentry Wilkerson, MD

  U of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: March 3, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)