Clinical trial NCT01897675: A Comparison of Techniques for Treating Skin Abscesses
Official title: Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Abscess
Keywords: Cutaneous Abscess
Emergency Department
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 233
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of abscesses traditionally involves incision and drainage (I\&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.

Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.

We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.

Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I\&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.

The study investigators will then compare outcomes between the two study groups.


Eligibility criteria: Inclusion Criteria:

* Adult patient over 18 years of age
* Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
* English speaking
* Able to provide written informed consent
* Willing to return in 14 days for follow-up visit
* Able to give a telephone number for follow-up contact

Exclusion Criteria:

* Previously treated for this abscess
* Altered mental status
* Patients with active psychiatric issues that preclude their ability to provide informed consent
* Previously enrolled in the study
* Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
* Abscess is post-operative or post-procedure
* Clinician determines abscess is not amenable to drainage by particular method
* Abscess is too small for packing or loop
* Need for hospital admission

Primary outcomes:
measure: Abscess Resolution
timeFrame: 14 days
Secondary outcomes:
measure: Patient Satisfaction Immediately After Procedure
timeFrame: Time 0
measure: Cosmetic Outcome
timeFrame: 14 days
measure: Patient Satisfaction after Abscess Resolution
timeFrame: 14 Days
measure: Number of Follow Up Visits
timeFrame: 14 days
measure: Number of Complications
timeFrame: 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Elissa Schechter-Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNamara WF, Hartin CW Jr, Escobar MA, Yamout SZ, Lau ST, Lee YH. An alternative to open incision and drainage for community-acquired soft tissue abscesses in children. J Pediatr Surg. 2011 Mar;46(3):502-6. doi: 10.1016/j.jpedsurg.2010.08.019.
citation: Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg. 2010 Jul;45(7):1562-6. doi: 10.1016/j.jpedsurg.2010.03.025.