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A Comparison of Techniques for Treating Skin Abscesses (LoopDrainage)

Primary Purpose

Cutaneous Abscess

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incision and Drainage with packing (wick) placement
Abscess drainage with loop placement
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Abscess focused on measuring Cutaneous Abscess, Emergency Department

Eligibility Criteria

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

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

Sites / Locations

  • Boston University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Incision and Drainage with Packing

Loop Drainage

Arm Description

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

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

Outcomes

Primary Outcome Measures

Abscess Resolution
If no, which sign is present (check all that apply): Fluctuance Drainage Induration Warmth Tenderness Other __________

Secondary Outcome Measures

Patient Satisfaction Immediately After Procedure
How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)
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
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
Number of Follow Up Visits
Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care
Number of Complications
need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission

Full Information

First Posted
July 9, 2013
Last Updated
April 5, 2018
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01897675
Brief Title
A Comparison of Techniques for Treating Skin Abscesses
Acronym
LoopDrainage
Official Title
Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess
Keywords
Cutaneous Abscess, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incision and Drainage with Packing
Arm Type
Active Comparator
Arm Description
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
Arm Title
Loop Drainage
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Incision and Drainage with packing (wick) placement
Intervention Type
Procedure
Intervention Name(s)
Abscess drainage with loop placement
Primary Outcome Measure Information:
Title
Abscess Resolution
Description
If no, which sign is present (check all that apply): Fluctuance Drainage Induration Warmth Tenderness Other __________
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Patient Satisfaction Immediately After Procedure
Description
How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)
Time Frame
Time 0
Title
Cosmetic Outcome
Description
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
Time Frame
14 days
Title
Patient Satisfaction after Abscess Resolution
Description
Patient Satisfaction with: Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale
Time Frame
14 Days
Title
Number of Follow Up Visits
Description
Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care
Time Frame
14 days
Title
Number of Complications
Description
need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissa Schechter-Perkins, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
20638546
Citation
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.
Results Reference
background
Links:
URL
http://vimeo.com/19580472
Description
Video of Loop Drainage Technique for Abscess care

Learn more about this trial

A Comparison of Techniques for Treating Skin Abscesses

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