MAR-CUTIS vs Dermabond A in Closure of Surgical Incisions/Lacerations

• Research type

  Research Study

• Full title

  A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS with Dermabond Advanced in Closure of Surgical Incisions and Lacerations ≤15cm

• IRAS ID

  251636

• Contact name

  Petra Jeevaratnam

• Contact email

  Regulatory.uk@grunenthal.com

• Sponsor organisation

  Grunenthal Ltd.

• Clinicaltrials.gov Identifier

  SURG 38929, NIHR CRN; CIV-18-08-025248, EUDAMED number

• Duration of Study in the UK

  0 years, 9 months, 1 days

• Research summary

  Grünenthal GmbH (the sponsor) is conducting this study to compare the effectiveness and safety of the study medical device MAR-CUTIS to DERMABOND ADVANCED.
  MAR-CUTIS is a topical skin adhesive intended for closure of incisions (cuts) and surgical wounds, replacing the last dermal suture line (stitches/staples) of the skin but is currently not intended for closure of lacerations. DERMABOND ADVANCED is also a skin adhesive approved as a wound closure device. It works by holding closed the skin edges created by surgical incisions or lacerations so healing can take place.
  The goal of wound closure after surgical incision is to make bleeding stop, avoid infection, and restore function to the affected skin area with minimal scarring. The application of skin adhesives may potentially offer advantages over standard (staple/stitches) methods.
  About 189 participants with surgical incisions or lacerations will take part in this study. The study is intended to run for approximately 4 months following the wound closure. Participants will be required to attend the research centre for follow-up visits, up to 6 times over this period.
  The study is divided into 3 time periods:
  • Screening period– to check if you meet the requirements to take part in this study
  • Treatment period – you will be assigned to receive either MAR-CUTIS or DERMABOND ADVANCED to close your wound
  • Follow-up period – evaluations on wound will occur on Day 1, 10, 1 month and 3 months after wound closure.

  Study procedures will be performed within these periods; However before any study procedures can be undertaken Informed Consent will be required. At scheduled study visits, participants will visit the research centre where study assessments will take place e.g. you will be asked questions on how you are feeling, medicines you are taking, evaluation of the device.

  Participation is voluntary.

• REC name

  West of Scotland REC 5

• REC reference

  18/WS/0172

• Date of REC Opinion

  19 Dec 2018

• REC opinion

  Further Information Favourable Opinion