The LOOP Trial in Treatment of Skin Abscesses

Study Overview
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Brief Summary
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This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.

Detailed Description
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This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.

Official Title
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The LOOP Trial: A Study Comparing the Use of the LOOP Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses in a Level I Emergency Department

Conditions
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Abscess

Intervention / Treatment
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* Procedure: LOOP Technique
* Procedure: Standard incision and drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subcutaneous skin abscesses necessitating drainage Exclusion Criteria: Abscess was on the hand, foot, or face Requiring admission or operative intervention
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 |
| --- | --- |
| Experimental: LOOP Technique<br>Placement of subcutaneous loop drain | Procedure: LOOP Technique<br>* Placement of subcutaneous loop drain<br>|
| Active Comparator: Incision and Drainage<br>Standard Incision and Drainage Technique | Procedure: Standard incision and drainage<br>* Incise and drain with placement of packing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failure | Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature | 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Pain | Procedure Pain using Likert scale 1-10 | At time of procedure | 
| Ease of procedure | Ease of procedure using Likert 1-10 scale | At time of procedure | 
| Ease of care | Ease of care using 1-10 Likert scale | During 10 days | 
| Pain on follow-up | Pain on follow-up using 1-10 Likert scale | 10 days | 
| Patient satisfaction | Patient satisfaction using Patient derived Likert scale | During 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soft tissue infection, MRSA