Loop Drainage: Effectiveness in Treating Cutaneous Abscesses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses

Conditions
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Abscess of Skin and/or Subcutaneous Tissue

Intervention / Treatment
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* Procedure: Traditional Incision and Drainage.
* Procedure: Loop drainage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Incision and Drainage<br>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.<br>* Control Group- Standard treatment of a simple cutaneous abscess with traditional I&D technique with or without packing utilizing a standard I&D kit.<br>|
| Experimental: Loop drainage<br>Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique. | Procedure: Loop drainage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abscess, Loop, Drainage