STEPS Study

• Research type

  Research Study

• Full title

  Study of TRE Seals on Early Post-operative Subjects (STEPS)

• IRAS ID

  242748

• Contact name

  James Hill

• Contact email

  james.hill@mft.nhs.uk

• Sponsor organisation

  Hollister Incorporated

• Duration of Study in the UK

  0 years, 4 months, 22 days

• Research summary

  Objective(s):
  The objective of this study is to assess the clinical and economic impact of the Dansac TRE Seal and Coloplast Brava Protective seal when used by newly post-operative stoma patients.

  Study Design:
  The study will take place at one or more sites and is randomized trial.

  Study Period:
  Subjects will be enrolled at Visit 1 (at the first pouching system change after surgery, approximately Day 1 post-op). Subjects will participate in study visits at 1 week, 3 weeks, 6 weeks, and 9 weeks post-op for a total of 5 visits over the course of 9 weeks.

  Target Number of Subjects:
  A convenience sample size of 60 subjects will be targeted.

  Eligibility Criteria:
  Subjects to be enrolled in this study are newly post-operative stoma creation surgery patients with any type of ostomy and deemed appropriate by the Investigator for the use of a seal.

  Study Product:
  The test product (Dansac TRE Seal, (Dansac, Fredensborg, Denmark) is a CE marked ostomy seal designed to maintain adhesive and absorption properties as well as maintain the skin’s natural pH balance. It is currently marketed in the UK and Japan.

  Coloplast Brava Protective Seal, (Coloplast, Humlebæk, Denmark) is a CE marked ostomy seal designed to protect against leakage and protect the skin by absorbing moisture and leaving minimal residue behind. It is currently marketed in the UK and other countries.

  Statistical Methods:
  Data collected for the primary and secondary objective will be analyzed using appropriate statistical methods as defined by the variable’s data-level (e.g. continuous, ordinal, categorical, etc.). The analyses will be descriptive and characteristic in nature and any statistical tests will be exploratory.

  Sample Size and Power:
  A convenience sample size of 60 subjects was chosen for this study. No formal power calculations were performed to determine sample size.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  18/NW/0599

• Date of REC Opinion

  5 Nov 2018

• REC opinion

  Further Information Favourable Opinion