The LOOP Trial in Treatment of Skin Abscesses

Abscess Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398746
• Other study ID #: 09.005.01
• Status: Completed
• Phase: N/A
• First received: January 3, 2018
• Last updated: January 6, 2018
• Start date: January 22, 2009
• Est. completion date: November 5, 2012

Study information

• Verified date: January 2018
• Source: Orlando Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: November 5, 2012
• Est. primary completion date: November 5, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria:

• Abscess was on the hand, foot, or face

• Requiring admission or operative intervention

Related Conditions & MeSH terms

• Abscess

Intervention

Procedure:
• LOOP Technique
Placement of subcutaneous loop drain
• Standard incision and drainage
Incise and drain with placement of packing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Regional Medical Center

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure	Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature	10 Days
Secondary	Procedure Pain	Procedure Pain using Likert scale 1-10	At time of procedure
Secondary	Ease of procedure	Ease of procedure using Likert 1-10 scale	At time of procedure
Secondary	Ease of care	Ease of care using 1-10 Likert scale	During 10 days
Secondary	Pain on follow-up	Pain on follow-up using 1-10 Likert scale	10 days
Secondary	Patient satisfaction	Patient satisfaction using Patient derived Likert scale	During 10 days

External Links

•   Link to PubMed Article