Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02697279|
Recruitment Status : Terminated (Unable to enroll the appropriate number of subjects within a reasonable timeframe.)
First Posted : March 3, 2016
Last Update Posted : October 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abscess of Skin and/or Subcutaneous Tissue||Procedure: Traditional Incision and Drainage. Procedure: Loop drainage||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 1, 2018|
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.
Procedure: Traditional Incision and Drainage.
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.
Procedure: Loop drainage
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.
- 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.
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697279
|United States, Maryland|
|University of Maryland Medical Systems|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||R. Gentry Wilkerson, MD||U of Maryland, Baltimore|