An Observational Study on Cutimed Sorbion Sorbact

• Research type

  Research Study

• Full title

  Prospective, multicentre, observational study to evaluate the clinical performance of a sterile, bacteria-binding, super absorbent wound dressing.

• IRAS ID

  199929

• Contact name

  Nicky Ivins

• Contact email

  Nicky.Ivins@wwic.wales

• Sponsor organisation

  BSN Medical GmbH

• Clinicaltrials.gov Identifier

  NCT02662218

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  This study is designed to document the clinical performance and safety of Cutimed® Sorbion® Sorbact® for the intended use in daily clinical practice. Manufacturers of medical devices are legally obliged to observe its performance in the market (Post-Market Surveillance, PMS) as a part of their quality management system and this study is a part of that
  Approximately 30 people will be taking part in this research study. The study will be started with one site (Welsh Wound Innovation Centre) and additional sites may be added later.
  The duration of the whole study will be approximately 5 months. Each patient will be treated with Cutimed® Sorbion® Sorbact® for a maximum of 14 days. Where a patient has more than one wound, the wound that exudes most will be selected for observation in this study.During the period of treatment, each patient will visit the clinic in order for the dressing change and for the study clinician to record data on the condition of the wound. The frequency of the visit will be decided by the study nurse. Depending upon the wound condition, the visit frequency may vary but, there will be a minimum of three visits per patient and a maximum of 14 visits. When 30 patients have completed the full 14 days of treatment, the data recorded will be analysed

• REC name

  Wales REC 1

• REC reference

  16/WA/0073

• Date of REC Opinion

  17 Mar 2016

• REC opinion

  Further Information Favourable Opinion