A Comparison of Techniques for Treating Skin Abscesses

Cutaneous Abscess Clinical Trial

— LoopDrainage  

Official title:

Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897675
• Other study ID #: H-32294
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: April 5, 2018
• Start date: August 2013
• Est. completion date: March 9, 2017

Study information

• Verified date: April 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: March 9, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Cutaneous Abscess
• Skin Diseases

Intervention

Procedure:
• Incision and Drainage with packing (wick) placement

• Abscess drainage with loop placement

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abscess Resolution	If no, which sign is present (check all that apply): Fluctuance; Drainage; Induration; Warmth; Tenderness; Other __________	14 days
Secondary	Patient Satisfaction Immediately After Procedure	How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)	Time 0
Secondary	Cosmetic Outcome	Appearance according to wound scale; Wound Scale (presence or absence of); Step-off of borders; Contour irregularities; Wound margin separation; Edge inversion; Excessive distortion; Overall appearance	14 days
Secondary	Patient Satisfaction after Abscess Resolution	Patient Satisfaction with: Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale	14 Days
Secondary	Number of Follow Up Visits	Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care	14 days
Secondary	Number of Complications	need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission	14 days

External Links

•   Video of Loop Drainage Technique for Abscess care