Mepilex Transfer Ag
DeviceA soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
NCT Number: NCT01964521
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
The Norfolk & Norwich University Hospitals NHS foundation, Norwich, Colney Lane, United Kingdom
Approximately 25-30 subjects from two to three centers will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.
Subjects to be included were to suffer from a DFU and being in need of anti-microbial wound dressing.
Dressing changes were to performed according to the local clinical routine (usually 3 times/week), evaluated during a total treatment period of maximum 4 weeks including weekly visits when assessments were being done. A record (dressing log) for Mepilex Transfer Ag and outer layers were to be filled in at every dressing change.
Photos taken directly upon dressing removal and after cleansing /debridement were to be collected to visually follow the ulcers status.
At each visit the investigators/nurse and subjects opinion (using an evaluation form) were to be asked for questions considering the use of Mepilex Transfer Ag. Pain before, during and after removal will be assessed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Time frame: 4 weeks
Evaluation of signs of infection (exudate) from baseline
Time frame: 4 weeks
Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain.
Molnlycke Health Care AB
Industry
An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
Acronym: MxT Ag 05
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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