Irrigation Versus no Irrigation for Cutaneous Abscess

May 1, 2017 updated by: Brian Chinnock, University of California, San Francisco

Is Routine Irrigation of Cutaneous Abscesses Necessary?

In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). Despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. Potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93721
        • Community Regional Trauma and Burn Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients 18 years of age and above
  2. Patients that require a cutaneous abscess incision and drainage

Exclusion Criteria:

  1. Unable to return for 48-hour followup.
  2. Patients being admitted to the hospital or going to the operating room for incision and drainage
  3. Pregnant patients
  4. Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Irrigation
THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I&D PROCEDURE
Procedure: Irrigation
The patient will receive irrigation as a part of their wound care
Placebo Comparator: No Irrigation
THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I&D PROCEDURE
Other: No Irrigation
The patient will not receive irrigation as part of their wound care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients needing further treatment after irrigation for I&D
Time Frame: 7 day phone follow-up

Percentage of patients needing further treatment i. Further treatment defined as

  1. Repeat I&D
  2. Addition of an antibiotic (as new or to a pre-existing antibiotic)

  3. Admission to hospital for cutaneous abscess-related problem

    1. Abscess
    2. Cellulitis
    3. Septic arthritis
    4. Sepsis
7 day phone follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS is correlated with decreased pain after I&D
Time Frame: two years
1) VAS post procedure pain score
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Brian Chinnock, MD, UCSF, Community Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10012010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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