The LOOP Trial in Treatment of Skin Abscesses

Not Applicable

Completed

• Conditions: Abscess
• Interventions: Procedure: LOOP Technique; Procedure: Standard incision and drainage

• Registration Number: NCT03398746
• Lead Sponsor: Orlando Regional Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01-22
• Primary Completion: 2012-11-05
• Study Completion: 2012-11-05
• Status Verified: 2018-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-06
• Last Update Submitted: 2018-01-06
• Study First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria

• Abscess was on the hand, foot, or face
• Requiring admission or operative intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOOP Technique	LOOP Technique	Placement of subcutaneous loop drain
Incision and Drainage	Standard incision and drainage	Standard Incision and Drainage Technique

Primary Outcome Measures

Name	Time	Method
Treatment Failure	10 Days	Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature

Secondary Outcome Measures

Name	Time	Method
Pain on follow-up	10 days	Pain on follow-up using 1-10 Likert scale
Procedure Pain	At time of procedure	Procedure Pain using Likert scale 1-10
Ease of procedure	At time of procedure	Ease of procedure using Likert 1-10 scale
Ease of care	During 10 days	Ease of care using 1-10 Likert scale
Patient satisfaction	During 10 days	Patient satisfaction using Patient derived Likert scale