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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03398746
Other study ID # 09.005.01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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