- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697279
Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
December 15, 2021 updated by: Richard Gentry Wilkerson, University of Maryland, Baltimore
Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Medical Systems
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional Incision and Drainage
Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider.
|
Control Group- Standard treatment of a simple cutaneous abscess with traditional I&D technique with or without packing utilizing a standard I&D kit.
|
Experimental: Loop drainage
Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure failure rate
Time Frame: 5 -7 days after procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in pain associated with the procedure using a visual analog pain scale
Time Frame: Measured after the procedure on day 1
|
To evaluate the difference in pain between the experimental and control groups associated with the procedure using a visual analog pain scale (0-100).
|
Measured after the procedure on day 1
|
Patient Satisfaction using a visual analog pain scale
Time Frame: 5-7 days after procedure
|
To measure the difference in patient satisfaction with overall treatment between the study and control groups using the visual analog scale (0-100).
|
5-7 days after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: R. Gentry Wilkerson, MD, U of Maryland, Baltimore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
March 2, 2016
First Posted (Estimate)
March 3, 2016
Study Record Updates
Last Update Posted (Actual)
January 5, 2022
Last Update Submitted That Met QC Criteria
December 15, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00066974
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abscess of Skin and/or Subcutaneous Tissue
-
Gary PeksaStony Brook University; Kaiser Permanente; The University of Texas Health Science... and other collaboratorsWithdrawnAbscess of Skin and/or Subcutaneous Tissue
-
Seton Healthcare FamilyScientific, Education and Research Foundation of UTSW AustinCompletedAbscess of Skin and/or Subcutaneous TissueUnited States
-
Cohera Medical, Inc.CompletedDisorder of Skin and/or Subcutaneous Tissue of TrunkUnited States
-
Federico II UniversityWithdrawnInfection of Skin and/or Subcutaneous TissueItaly
-
Endo PharmaceuticalsCompleted
-
Affinium Pharmaceuticals, LtdCompletedCellulitis | Wound Infection | Skin and Subcutaneous Tissue Bacterial Infections | Cutaneous Abscess | Burn InfectionUnited States, Canada
-
University of California, San FranciscoRecruiting
-
Rush University Medical CenterWithdrawn
-
Tufts Medical CenterCompletedCutaneous AbscessUnited States
-
Ahmed A. H. AbdellatifUnknownSkin and Subcutaneous Tissue DisordersEgypt, Saudi Arabia
Clinical Trials on Traditional Incision and Drainage.
-
bryan malcolmWithdrawn
-
University of Massachusetts, WorcesterCompleted
-
Gary PeksaStony Brook University; Kaiser Permanente; The University of Texas Health Science... and other collaboratorsWithdrawnAbscess of Skin and/or Subcutaneous Tissue
-
Seton Healthcare FamilyScientific, Education and Research Foundation of UTSW AustinCompletedAbscess of Skin and/or Subcutaneous TissueUnited States
-
Samsun Education and Research HospitalCompletedIdiopathic Granulomatous MastitisTurkey
-
Kocaeli UniversityCompleted
-
Peking Union Medical College HospitalUnknown
-
University of Massachusetts, WorcesterBeth Israel Deaconess Medical CenterCompletedAbscess | CellulitisUnited States
-
Boston Medical CenterCompletedCutaneous AbscessUnited States