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The LOOP Trial in Treatment of Skin Abscesses

Primary Purpose

Abscess

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

LOOP Technique

Standard incision and drainage

About this trial

This is an interventional treatment trial for Abscess focused on measuring soft tissue infection, MRSA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LOOP Technique

Incision and Drainage

Arm Description

Placement of subcutaneous loop drain

Standard Incision and Drainage Technique

Outcomes

Primary Outcome Measures

Treatment Failure

Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature

Secondary Outcome Measures

Procedure Pain

Procedure Pain using Likert scale 1-10

Ease of procedure

Ease of procedure using Likert 1-10 scale

Ease of care

Ease of care using 1-10 Likert scale

Pain on follow-up

Pain on follow-up using 1-10 Likert scale

Patient satisfaction

Patient satisfaction using Patient derived Likert scale

Full Information

NCT ID

NCT03398746

First Posted

January 3, 2018

Last Updated

January 6, 2018

Sponsor

Orlando Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03398746

Brief Title

The LOOP Trial in Treatment of Skin Abscesses

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 22, 2009 (Actual)

Primary Completion Date

November 5, 2012 (Actual)

Study Completion Date

November 5, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Orlando Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abscess

Keywords

soft tissue infection, MRSA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

217 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LOOP Technique

Arm Type

Experimental

Arm Description

Placement of subcutaneous loop drain

Arm Title

Incision and Drainage

Arm Type

Active Comparator

Arm Description

Standard Incision and Drainage Technique

Intervention Type

Procedure

Intervention Name(s)

LOOP Technique

Intervention Description

Placement of subcutaneous loop drain

Intervention Type

Procedure

Intervention Name(s)

Standard incision and drainage

Intervention Description

Incise and drain with placement of packing

Primary Outcome Measure Information:

Title

Treatment Failure

Description

Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature

Time Frame

10 Days

Secondary Outcome Measure Information:

Title

Procedure Pain

Description

Procedure Pain using Likert scale 1-10

Time Frame

At time of procedure

Title

Ease of procedure

Description

Ease of procedure using Likert 1-10 scale

Time Frame

At time of procedure

Title

Ease of care

Description

Ease of care using 1-10 Likert scale

Time Frame

During 10 days

Title

Pain on follow-up

Description

Pain on follow-up using 1-10 Likert scale

Time Frame

10 days

Title

Patient satisfaction

Description

Patient satisfaction using Patient derived Likert scale

Time Frame

During 10 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subcutaneous skin abscesses necessitating drainage Exclusion Criteria: Abscess was on the hand, foot, or face Requiring admission or operative intervention

12. IPD Sharing Statement

Citations:

PubMed Identifier

25435407

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.

Results Reference

background

PubMed Identifier

32770686

Citation

Ladde J, Baker S, Lilburn N, Wan M, Papa L. A Randomized Controlled Trial of Novel Loop Drainage Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses. Acad Emerg Med. 2020 Dec;27(12):1229-1240. doi: 10.1111/acem.14106. Epub 2020 Oct 11.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=25435407

Description

Link to PubMed Article

Learn more about this trial

The LOOP Trial in Treatment of Skin Abscesses

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