NCT03398746

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2012

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

January 3, 2018

Last Update Submit

January 6, 2018

Conditions

Abscess

Keywords

soft tissue infectionMRSA

Outcome Measures

Primary Outcomes (1)

  • Treatment Failure

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

    10 Days

Secondary Outcomes (5)

  • 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

Study Arms (2)

LOOP Technique

EXPERIMENTAL

Placement of subcutaneous loop drain

Procedure: LOOP Technique

Incision and Drainage

ACTIVE COMPARATOR

Standard Incision and Drainage Technique

Procedure: Standard incision and drainage

Interventions

LOOP TechniquePROCEDURE

Placement of subcutaneous loop drain

LOOP Technique
Standard incision and drainagePROCEDURE

Incise and drain with placement of packing

Incision and Drainage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subcutaneous skin abscesses necessitating drainage

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 25435407BACKGROUND

  • 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.

    PMID: 32770686DERIVED

Related Links

MeSH Terms

Conditions

AbscessSoft Tissue Infections

Interventions

LAMP assayDrainage

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Program Director

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 12, 2018

Study Start

January 22, 2009

Primary Completion

November 5, 2012

Study Completion

November 5, 2012

Last Updated

January 12, 2018

Record last verified: 2018-01