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

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670201
First Posted: August 22, 2012
Last Update Posted: September 10, 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.
Information provided by (Responsible Party):
Molnlycke Health Care AB
Results First Submitted: April 3, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Donor Site Complication
Intervention: Device: Mepilex Transfer Ag

  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
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
  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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  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:  
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



Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01670201     History of Changes
Other Study ID Numbers: MxT Ag 01
First Submitted: June 12, 2012
First Posted: August 22, 2012
Results First Submitted: April 3, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014