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Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01365273
First received: May 27, 2011
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
Results First Received: May 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Deep Partial Thickness Burn
Full Thickness Burns
Intervention: Device: Mepitel One

  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
Date of first patient included: 26 April 2011 Date of last patient completed: 01 December 2011

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
Bridal Veil and Staples Bridal Veil and staples are standard of care I
Mepitel One Device

Participant Flow:   Overall Study
    Bridal Veil and Staples     Mepitel One  
STARTED     22     21  
Compl. Pts, Not Evaluable for Pain.     2     4  
COMPLETED     20     20  
NOT COMPLETED     2     1  
Lost to Follow-up                 1                 0  
Protocol Violation                 0                 1  
Physician Decision                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Bridal Veil and Staples Bridal Veil and staples are standard of care I
Mepitel One Device
Total Total of all reporting groups

Baseline Measures
    Bridal Veil and Staples     Mepitel One     Total  
Number of Participants  
[units: participants]
 		  22     21     43  
Age  
[units: years]
Mean ± Standard Deviation 		  42.3  ± 16.0     38.0  ± 18.0     40.15  ± 17  
Gender  
[units: participants]
 		     
Female     3     5     8  
Male     19     16     35  



  Outcome Measures
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1.  Primary:   VAS Score for Pain Before Dressing Removal   [ Time Frame: At visit 6, day 7 ]
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2.  Primary:   VAS Score for Pain During Dressing Removal   [ Time Frame: Visit 6, day 7 ]
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3.  Primary:   VAS Score for Pain After Dressing Removal   [ Time Frame: Visit 6, day 7 ]
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  Serious Adverse Events
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  Other Adverse Events
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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.  


Results Point of Contact:  
Name/Title: Joan Wilson, MSN, MHA, RN
Organization: Monlycke Health Care
phone: 706 504 8997
e-mail: joan.wilson@molnlycke.com


No publications provided


Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01365273     History of Changes
Other Study ID Numbers: MPTO 04
Study First Received: May 27, 2011
Results First Received: May 2, 2012
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board