NCT01606657

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

4.1 years

First QC Date

May 21, 2012

Last Update Submit

May 1, 2017

Conditions

Cutaneous Abscess

Keywords

I&DAbscessIrrigationCutaneous Abscess

Outcome Measures

Primary Outcomes (1)

  • Patients needing further treatment after irrigation for I&D

    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 Outcomes (1)

  • VAS is correlated with decreased pain after I&D

    two years

Study Arms (2)

Irrigation

ACTIVE COMPARATOR

THE PATIENT IS TO HAVE IRRIGATION OF THE ABSCESS WITH NORMAL SALINE AS PART OF THE I\&D PROCEDURE

Procedure: Irrigation

No Irrigation

PLACEBO COMPARATOR

THE PATIENT IS NOT TO HAVE IRRIGATION OF THE ABSCESS AS PART OF THE I\&D PROCEDURE

Other: No Irrigation

Interventions

IrrigationPROCEDURE

The patient will receive irrigation as a part of their wound care

Irrigation
No IrrigationOTHER

The patient will not receive irrigation as part of their wound care

No Irrigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Regional Trauma and Burn Center

Fresno, California, 93721, United States

Location

Related Publications (4)

  • O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10.

    PMID: 19388915BACKGROUND

  • Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6. doi: 10.1111/j.1445-2197.1997.tb01934.x.

    PMID: 9137156BACKGROUND

  • Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.

    PMID: 3880635BACKGROUND

  • Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7. doi: 10.1002/bjs.1800720125.

    PMID: 3881155BACKGROUND

MeSH Terms

Conditions

Abscess

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Brian Chinnock, MD

    UCSF, Community Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor of Emergency Medicine, Director of Coding/Reimbursement

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 28, 2012

Study Start

August 1, 2010

Primary Completion

September 1, 2014

Study Completion

April 1, 2015

Last Updated

May 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)