A Comparison of Techniques for Treating Skin Abscesses

NCT01897675 | Completed DMC

• 1 other identifier: H-32294
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Abscess

Keywords

Cutaneous Abscess; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Abscess Resolution

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

  14 days

Secondary Outcomes (5)

• Patient Satisfaction Immediately After Procedure

  Time 0

• Cosmetic Outcome

  14 days

• Patient Satisfaction after Abscess Resolution

  14 Days

• Number of Follow Up Visits

  14 days

• Number of Complications

  14 days

Study Arms (2)

Incision and Drainage with Packing

ACTIVE COMPARATOR

Abscess is cared for in the standard fashion, using an incision and drainage with packing (wick) placement. Packing to be changed every 2-3 days, at the discretion of the treating clinician, until abscess is considered resolved

Procedure: Incision and Drainage with packing (wick) placement

Loop Drainage

EXPERIMENTAL

Abscess is cared for using a minimally invasive abscess drainage with loop placement technique. Two (or more) stab incisions are made in the abscess, the cavity is probed and pus is drained, and a vessel loop is inserted and tied off. The patient manipulates the loop 3 times per day, and removes the loop when all redness is gone and no more pus is present

Procedure: Abscess drainage with loop placement

Interventions

Incision and Drainage with packing (wick) placement PROCEDURE

Incision and Drainage with Packing

Abscess drainage with loop placement PROCEDURE

Loop Drainage

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• 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.

  PMID: 21376200 BACKGROUND

• 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.

  PMID: 20638546 BACKGROUND

Related Links

• Video of Loop Drainage Technique for Abscess care

MeSH Terms

Conditions

Emergencies

Interventions

Drainage; Drug Packaging; Drug Implants

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative; Technology, Pharmaceutical; Investigative Techniques; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Elissa Schechter-Perkins, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 9, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)