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An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01670201
First received: June 12, 2012
Last updated: September 3, 2014
Last verified: February 2013
Results First Received: April 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Donor Site Complication
Intervention: Device: Mepilex Transfer Ag

  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
Mepilex Transfer Ag

Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.

Mepilex Transfer Ag: Silver dressing


Participant Flow:   Overall Study
    Mepilex Transfer Ag  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     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.
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Reporting Groups
  Description
Mepilex Transfer Ag

Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.

Mepilex Transfer Ag: Silver dressing


Baseline Measures
    Mepilex Transfer Ag  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Gender  
[units: participants]
 
Female     3  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Had > 95 % Epithelialization at Day 10   [ Time Frame: 10 days ]

2.  Secondary:   Pain at Dressing Changes   [ Time Frame: 28 days ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Nicole Gibran
Organization: Harborview Medical Center / Seattle, Washington
phone: 206-744-3140
e-mail: nicoleg@uw.edu


No publications provided


Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01670201     History of Changes
Other Study ID Numbers: MxT Ag 01
Study First Received: June 12, 2012
Results First Received: April 3, 2014
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board