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The LOOP Trial in Treatment of Skin Abscesses

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398746
Enrollment
217
Registered
2018-01-12
Start date
2009-01-22
Completion date
2012-11-05
Last updated
2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess

Keywords

soft tissue infection, MRSA

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.

Interventions

PROCEDURELOOP Technique

Placement of subcutaneous loop drain

PROCEDUREStandard incision and drainage

Incise and drain with placement of packing

Sponsors

Orlando Regional Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Subcutaneous skin abscesses necessitating drainage

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment Failure10 DaysNeed for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature

Secondary

MeasureTime frameDescription
Procedure PainAt time of procedureProcedure Pain using Likert scale 1-10
Ease of procedureAt time of procedureEase of procedure using Likert 1-10 scale
Ease of careDuring 10 daysEase of care using 1-10 Likert scale
Pain on follow-up10 daysPain on follow-up using 1-10 Likert scale
Patient satisfactionDuring 10 daysPatient satisfaction using Patient derived Likert scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026