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

The LOOP Trial in Treatment of Skin Abscesses



Sponsors


Source

Orlando Regional Medical Center

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Completed

Start Date

2009-01-22

Completion Date

2012-11-05

Primary Completion Date

2012-11-05

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Treatment Failure
10 Days

Secondary Outcome

Measure

Time Frame

Procedure Pain
At time of procedure
Ease of procedure
At time of procedure
Ease of care
During 10 days
Pain on follow-up
10 days
Patient satisfaction
During 10 days

Enrollment

217

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

Placement of subcutaneous loop drain

Arm Group Label

LOOP Technique


Intervention Type

Procedure

Intervention Name


Description

Incise and drain with placement of packing

Arm Group Label

Incision and Drainage



Eligibility

Criteria

Inclusion Criteria:

- Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria:

- Abscess was on the hand, foot, or face

- Requiring admission or operative intervention

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Verification Date

2018-01-01

Lastchanged Date

2018-01-06

Firstreceived Date

2018-01-03

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Orlando Regional Medical Center

Investigator Full Name

Jay Ladde

Investigator Title

Associate Program Director


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

LOOP Technique

Arm Group Type

Experimental

Description

Placement of subcutaneous loop drain


Arm Group Label

Incision and Drainage

Arm Group Type

Active Comparator

Description

Standard Incision and Drainage Technique



Firstreceived Results Date

N/A

Reference

Citation

Ladde JG, Baker S, Rodgers CN, Papa L. The LOOP technique: a novel incision and drainage technique in the treatment of skin abscesses in a pediatric ED. Am J Emerg Med. 2015 Feb;33(2):271-6. doi: 10.1016/j.ajem.2014.10.014. Epub 2014 Oct 16.

PMID

25435407


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

January 3, 2018

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

January 6, 2018

Last Update Submitted Qc

January 6, 2018

Last Update Posted

January 12, 2018


ClinicalTrials.gov processed this data on January 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP