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Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®

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ClinicalTrials.gov Identifier: NCT00742183
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : November 19, 2010
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Second Degree Burn
Interventions: Device: Mepilex
Device: Silvadene

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Investigation period: Sept 2008 - Sept 2009. In- and/or out-patients at ten centers in US were included in this investigation. Subjects included were 5 years and above and suffered from partial thickness burns.

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 Ag

Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag.

Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn

Silvadene Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.

Participant Flow:   Overall Study
    Mepilex Ag   Silvadene
STARTED   49 [1]   51 
COMPLETED   40   39 
NOT COMPLETED   9   12 
Adverse Event                2                2 
Death                1                0 
Physician Decision                0                2 
Lost to Follow-up                4                4 
Required skin-graft                1                1 
Withdrawal by Subject                1                0 
Lack of Efficacy                0                3 
[1] 50 subjects randomised, one of them did not receive any treatment.



  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® Ag The dressing to be used Mepilex® Ag, consists of an absorbent polyurethane foam pad containing silver sulphate with a silicone contact layer with the Safetac® technology. The silver ions are hydro activated in presence of fluid or wound exudates.
Silvadene® Cream 1% Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns.
Total Total of all reporting groups

Baseline Measures
   Mepilex® Ag   Silvadene® Cream 1%   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   51   100 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4   8.2%      4   7.8%      8   8.0% 
Between 18 and 65 years      41  83.7%      41  80.4%      82  82.0% 
>=65 years      4   8.2%      6  11.8%      10  10.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.0  (18.1)   39.2  (18.2)   38.4  (18.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  26.5%      10  19.6%      23  23.0% 
Male      36  73.5%      41  80.4%      77  77.0% 
Region of Enrollment 
[Units: Participants]
     
United States   49   51   100 


  Outcome Measures

1.  Primary:   Compare the Costs of Using the Interventions (Direct and Indirect)   [ Time Frame: August 2008-August 2009 ]


  Serious Adverse Events


  Other Adverse Events


  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

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.


Results Point of Contact:  
Name/Title: Viktoria Ahlenius Körner
Organization: Mölnlycke Health Care
phone: +46-31-722 32 46
e-mail: viktoria.ahleniuskorner@molnlycke.com



Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT00742183     History of Changes
Other Study ID Numbers: PUMA 415
First Submitted: August 19, 2008
First Posted: August 27, 2008
Results First Submitted: June 3, 2010
Results First Posted: November 19, 2010
Last Update Posted: December 8, 2017