The LOOP Trial in Treatment of Skin Abscesses

Orlando Regional Medical Center

Status: Completed

Conditions: Abscess

Treatments: Procedure: Standard incision and drainage; Procedure: LOOP Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03398746

09.005.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subcutaneous skin abscesses necessitating drainage

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

LOOP Technique

Experimental group

Description:

Placement of subcutaneous loop drain

Treatment:

Procedure: LOOP Technique

Incision and Drainage

Active Comparator group

Description:

Standard Incision and Drainage Technique

Treatment:

Procedure: Standard incision and drainage