The LOOP Trial in Treatment of Skin Abscesses

NCT ID: NCT03398746

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-22
• Study Completion Date: 2012-11-05

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.

Conditions

Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LOOP Technique

Placement of subcutaneous loop drain

Group Type: EXPERIMENTAL

LOOP Technique

Intervention Type: PROCEDURE

Placement of subcutaneous loop drain

Incision and Drainage

Standard Incision and Drainage Technique

Group Type: ACTIVE_COMPARATOR

Standard incision and drainage

Intervention Type: PROCEDURE

Incise and drain with placement of packing

Interventions

LOOP Technique

Placement of subcutaneous loop drain

Intervention Type: PROCEDURE

Standard incision and drainage

Incise and drain with placement of packing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orlando Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jay Ladde

Associate Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 25435407 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32770686 (View on PubMed)

Related Links

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

Link to PubMed Article

Other Identifiers

09.005.01

Identifier Type: -

Identifier Source: org_study_id