A Comparison of Techniques for Treating Skin Abscesses (LoopDrainage)

Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?

Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.

Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.

We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.

Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.

The study investigators will then compare outcomes between the two study groups.

Study Overview

• Status: Completed
• Conditions: Cutaneous Abscess
• Intervention / Treatment: Procedure: Incision and Drainage with packing (wick) placement; Procedure: Abscess drainage with loop placement

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patient over 18 years of age
• Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
• English speaking
• Able to provide written informed consent
• Willing to return in 14 days for follow-up visit
• Able to give a telephone number for follow-up contact

Exclusion Criteria:

• Previously treated for this abscess
• Altered mental status
• Patients with active psychiatric issues that preclude their ability to provide informed consent
• Previously enrolled in the study
• Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
• Abscess is post-operative or post-procedure
• Clinician determines abscess is not amenable to drainage by particular method
• Abscess is too small for packing or loop
• Need for hospital admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Incision and Drainage with Packing; Abscess is cared for in the standard fashion, using an incision and drainage with packing (wick) placement. Packing to be changed every 2-3 days, at the discretion of the treating clinician, until abscess is considered resolved	Procedure: Incision and Drainage with packing (wick) placement
EXPERIMENTAL: Loop Drainage; Abscess is cared for using a minimally invasive abscess drainage with loop placement technique. Two (or more) stab incisions are made in the abscess, the cavity is probed and pus is drained, and a vessel loop is inserted and tied off. The patient manipulates the loop 3 times per day, and removes the loop when all redness is gone and no more pus is present	Procedure: Abscess drainage with loop placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abscess Resolution	If no, which sign is present (check all that apply): Fluctuance; Drainage; Induration; Warmth; Tenderness; Other __________	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Immediately After Procedure	How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)	Time 0
Cosmetic Outcome	Appearance according to wound scale Wound Scale (presence or absence of); Step-off of borders; Contour irregularities; Wound margin separation; Edge inversion; Excessive distortion; Overall appearance	14 days
Patient Satisfaction after Abscess Resolution	Patient Satisfaction with: Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale	14 Days
Number of Follow Up Visits	Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care	14 days
Number of Complications	need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission	14 days

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Elissa Schechter-Perkins, MD, MPH, Boston Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Video of Loop Drainage Technique for Abscess care

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 9, 2017

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (ESTIMATE): July 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Emergency Department; Cutaneous Abscess
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Skin Diseases
• Other Study ID Numbers: H-32294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No