NCT01636362

A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.

Detailed description

see Brief summary

Conditions

• Burns
• Wound Healing

Interventions

Type	Name	Description
DEVICE	Mepitel Ag	Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-07-10
• Last updated: 2014-10-07
• Results posted: 2014-09-05

Locations

6 sites across 1 country: United States