PMCF Study in Patients using a KerraCel™ Dressing

• Research type

  Research Study

• Full title

  Prospective, Observational, Post Market, Clinical Follow-Up (PMCF) Study in Patients using KerraCel™ Dressing on Oncological and Traumatic Wounds

• IRAS ID

  288315

• Contact name

  Jason Wong

• Contact email

  Jason.K.Wong@manchester.ac.uk

• Sponsor organisation

  KCI USA, Inc.

• ISRCTN Number

  ISRCTN33932204

• Duration of Study in the UK

  1 years, 7 months, 1 days

• Research summary

  There is limited data on use of the KerraCel™ dressing with oncology and traumatic wounds. Patients who have either oncology or traumatic wounds will be evaluated for the study and if they meet the criteria, will be treated for up to a maximum of 21 days with the KerraCel™ dressing or have at least 3 dressing changes. A total of 40 subjects will be enrolled with a minimum of 10 of both the oncology and traumatic wound groups. All subjects will be evaluated for safety events and the progress of their wound healing. Data will be collected on a subject's medical history, medications, characteristics of the wound and images taken of the wound by a 3D camera.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/PR/0337

• Date of REC Opinion

  26 Apr 2021

• REC opinion

  Further Information Favourable Opinion