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A Comparison of Techniques for Treating Skin Abscesses

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01897675
Acronym
LoopDrainage
Enrollment
233
Registered
2013-07-12
Start date
2013-08-31
Completion date
2017-03-09
Last updated
2018-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Abscess

Keywords

Cutaneous Abscess, Emergency Department

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.

Interventions

PROCEDUREIncision and Drainage with packing (wick) placement
PROCEDUREAbscess drainage with loop placement

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Abscess Resolution14 daysIf no, which sign is present (check all that apply): 1. Fluctuance 2. Drainage 3. Induration 4. Warmth 5. Tenderness 6. Other \_\_\_\_\_\_\_\_\_\_

Secondary

MeasureTime frameDescription
Patient Satisfaction Immediately After ProcedureTime 0How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)
Cosmetic Outcome14 daysAppearance according to wound scale Wound Scale (presence or absence of) 1. Step-off of borders 2. Contour irregularities 3. Wound margin separation 4. Edge inversion 5. Excessive distortion 6. Overall appearance
Patient Satisfaction after Abscess Resolution14 DaysPatient Satisfaction with: Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale
Number of Follow Up Visits14 daysNumber of follow-up visits made to either Emergency Department or outpatient clinic for abscess care
Number of Complications14 daysneed for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026