The LOOP Trial in Treatment of Skin Abscesses

January 6, 2018 updated by: Jay Ladde, Orlando Regional Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

217

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LOOP Technique
Placement of subcutaneous loop drain
Procedure: LOOP Technique
Placement of subcutaneous loop drain
Active Comparator: Incision and Drainage
Standard Incision and Drainage Technique
Procedure: Standard incision and drainage
Incise and drain with placement of packing

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2009

Primary Completion (Actual)

November 5, 2012

Study Completion (Actual)

November 5, 2012

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 6, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 6, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.005.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abscess

Clinical Trials on LOOP Technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe