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:
Collaborator:
Irrimax Corporation
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01302548
First received: September 29, 2010
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: September 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Abscess
Interventions: Device: IRRISEPT
Procedure: Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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  
Number of Participants  
[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
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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
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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
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  More Information
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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


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01302548     History of Changes
Other Study ID Numbers: 20101227
Study First Received: September 29, 2010
Results First Received: September 9, 2013
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board