Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
Primary Purpose
Abscess of Skin and/or Subcutaneous Tissue
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Incision and Drainage.
Loop drainage
Sponsored by
About this trial
This is an interventional treatment trial for Abscess of Skin and/or Subcutaneous Tissue focused on measuring Abscess, Loop, Drainage
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Presents to ED with simple cutaneous abscess
- Provides informed consent.
Exclusion Criteria:
- 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
- Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
Sites / Locations
- University of Maryland Medical Systems
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Incision and Drainage
Loop drainage
Arm Description
Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider.
Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Difference in pain associated with the procedure using a visual analog pain scale
To evaluate the difference in pain between the experimental and control groups associated with the procedure using a visual analog pain scale (0-100).
Patient Satisfaction using a visual analog pain scale
To measure the difference in patient satisfaction with overall treatment between the study and control groups using the visual analog scale (0-100).
Full Information
NCT ID
NCT02697279
First Posted
February 4, 2016
Last Updated
December 15, 2021
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT02697279
Brief Title
Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
Official Title
Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll the appropriate number of subjects within a reasonable timeframe.
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study, will be consented. Study subjects will be enrolled and randomly assigned to either the study or control groups.
Control Group- standard I & D method for cutaneous abscess.
Study Group- Loop Technique:
Gather all of your material and bring to bedside
Clean area with chlorhexidine or iodine swabs
Anesthetize area
Use your scalpel to make small 5mm incision at most fluctuant area of abscess
Explore cavity with your hemostat and break down loculations
Make second incision less than 4cm away from first incision. Feel borders of abscess, and try to make second incision as far within cavity as you can.
For larger abscesses can repeat step 5 thus creating several LOOPs.
Irrigate cavity with saline flush
Pass hemostat through both incisions and pull loop vessel, penrose, or bottom of glove through. Keep your loop device equal in length on both sides.
Tie loop device loosely over 30cc syringe to form LOOP. Usually 5-6 knots. This helps prevent loop from falling out prematurely.
Slide syringe out, and trim free ends of loop. Make sure loop is mobile.
Cover site with dry dressing. Follow-Up-
Wound check in 1-2 days
Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess of Skin and/or Subcutaneous Tissue
Keywords
Abscess, Loop, Drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Incision and Drainage
Arm Type
Active Comparator
Arm Description
Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider.
Arm Title
Loop drainage
Arm Type
Experimental
Arm Description
Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique.
Intervention Type
Procedure
Intervention Name(s)
Traditional Incision and Drainage.
Intervention Description
Control Group- Standard treatment of a simple cutaneous abscess with traditional I&D technique with or without packing utilizing a standard I&D kit.
Intervention Type
Procedure
Intervention Name(s)
Loop drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedure failure rate
Description
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.
Time Frame
5 -7 days after procedure
Secondary Outcome Measure Information:
Title
Difference in pain associated with the procedure using a visual analog pain scale
Description
To evaluate the difference in pain between the experimental and control groups associated with the procedure using a visual analog pain scale (0-100).
Time Frame
Measured after the procedure on day 1
Title
Patient Satisfaction using a visual analog pain scale
Description
To measure the difference in patient satisfaction with overall treatment between the study and control groups using the visual analog scale (0-100).
Time Frame
5-7 days after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Presents to ED with simple cutaneous abscess
Provides informed consent.
Exclusion Criteria:
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
Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Gentry Wilkerson, MD
Organizational Affiliation
U of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Systems
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
PubMed Identifier
19038518
Citation
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.
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
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
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
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
background
PubMed Identifier
19328372
Citation
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.
Results Reference
background
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Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
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