We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department

This study has been terminated.
(Study did not accrue the required number of study subjects.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302548
First Posted: February 24, 2011
Last Update Posted: April 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Irrimax Corporation
Information provided by (Responsible Party):
University of Florida
Results First Submitted: September 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Abscess
Interventions: Device: IRRISEPT
Procedure: Usual Care

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IRRISEPT Device containing sterile water and chlorhexidine gluconate (CHG)
Usual Care The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.

Participant Flow:   Overall Study
    IRRISEPT   Usual Care
STARTED   14   19 
COMPLETED   12   18 
NOT COMPLETED   2   1 
Lost to Follow-up                2                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IRRISEPT Device containing sterile water and chlorhexidine gluconate (CHG)
Usual Care The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Total Total of all reporting groups

Baseline Measures
   IRRISEPT   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   19   33 
Age 
[Units: Participants]
     
<=18 years   0   2   2 
Between 18 and 65 years   14   17   31 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.42  (9.04)   24.83  (9.81)   27.87  (10.08) 
Gender 
[Units: Participants]
     
Female   5   10   15 
Male   9   9   18 
Region of Enrollment 
[Units: Participants]
     
United States   14   19   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Abscess Healing Based on Abscess Measurement Scale   [ Time Frame: 48 hours ]

2.  Secondary:   Number of Patients Prescribed Oral Antibiotics   [ Time Frame: 48 hours ]

3.  Secondary:   Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.   [ Time Frame: 48 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Richard F Petrik, MD
Organization: University of Florida
phone: 352-265-5911
e-mail: rpetrik@ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01302548     History of Changes
Other Study ID Numbers: 20101227
First Submitted: September 29, 2010
First Posted: February 24, 2011
Results First Submitted: September 9, 2013
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014