Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

This study has been completed.
Sponsor:
Information provided by:
Vomaris Innovations
ClinicalTrials.gov Identifier:
NCT00816101
First received: October 21, 2008
Last updated: March 4, 2011
Last verified: March 2011
Results First Received: December 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Wounds
Interventions: Other: Procellera™ Antimicrobial Dressing
Other: Mepilex® Border Lite
Device: Adhesive Bandage

  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
Recruitment dates: June 2008-August 2008 Location: Dermatology Clinic

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
Procellera Dressing

Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.

Dressing changes every 3 days, more frequently if needed

Mepilex® Border Lite Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
Band-Aid® Adhesive Bandage Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.

Participant Flow:   Overall Study
    Procellera Dressing     Mepilex® Border Lite     Band-Aid® Adhesive Bandage  
STARTED     13     8     5  
COMPLETED     13     8     5  
NOT COMPLETED     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
Procellera Dressing

Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.

Dressing changes every 3 days, more frequently if needed

Mepilex® Border Lite Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
Band-Aid® Adhesive Bandage Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
Total Total of all reporting groups

Baseline Measures
    Procellera Dressing     Mepilex® Border Lite     Band-Aid® Adhesive Bandage     Total  
Number of Participants  
[units: participants]
  13     8     5     26  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     1     1     1     3  
>=65 years     12     7     4     23  
Age  
[units: years]
Mean ± Standard Deviation
  76.6  ± 8.4     74.8  ± 9.9     76.6  ± 8.4     74.9  ± 8.6  
Gender  
[units: participants]
       
Female     4     2     2     8  
Male     9     6     3     18  
Region of Enrollment  
[units: participants]
       
United States     13     8     5     26  



  Outcome Measures
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1.  Primary:   Number of Patients Who Experienced 50% or Greater Wound Healing   [ Time Frame: 3 Weeks ]

2.  Secondary:   Number of Patients Reporting Pain   [ Time Frame: 3 Weeks ]

3.  Secondary:   Erythema at Week 3   [ Time Frame: 3 Weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott Sheftel, MD
Organization: Sheftel Associates Dermatology, LLC
phone: 520-293-5757 ext 7106
e-mail: ssheftel@sheftelderm.com


No publications provided


Responsible Party: Manager of Clinical Affairs, Vomaris Innovations, Inc.
ClinicalTrials.gov Identifier: NCT00816101     History of Changes
Other Study ID Numbers: XSMP-002
Study First Received: October 21, 2008
Results First Received: December 13, 2010
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board