6042-OST Study of TRE Seals on Early Post-Operative Subjects
Research type
Research Study
Full title
6042-OST Study of TRE Seals on Early Post-Operative Subjects (TRE STEPS)
IRAS ID
369360
Contact name
John K.H. Whitaker
Contact email
Sponsor organisation
Hollister Incorporated
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This study will evaluate two types of a commercially available ostomy seals used in routine NHS ostomy care. The purpose of the study is to compare how well the different types of seals perform in adults with a stoma immediately post-surgery including comfort, fit, skin health, and overall user experience.
Ostomy appliances and accessories are widely used medical devices designed to collect output from a surgically created opening (stoma). Although these products are already approved for use and routinely prescribed, there is limited comparative evidence on performance between different seal options in everyday clinical practice. This study aims to generate high-quality evidence to support clinicians and patients in selecting the most appropriate seal.
Participants will be adults who have a newly established stoma and will be starting to use ostomy products and accessories as part of their ostomy care practices. After providing informed consent, participants will be allocated to use one of the study product types for a defined study period. They will complete questionnaires about comfort, leakage, ease of use, and skin condition. Clinical assessments of peristomal skin health may also be conducted during routine care visits. No additional invasive procedures are required.
Both products are UKCA/CE marked and used within their intended purpose. The risks to participants are minimal and similar to normal use of standard ostomy appliances. Participants may benefit from closer monitoring of their stoma care and from trying a product that may improve fit or comfort.
The results of this study will help inform future clinical practice and product selection within the NHS.
REC name
Wales REC 6
REC reference
26/WA/0105
Date of REC Opinion
14 Apr 2026
REC opinion
Further Information Favourable Opinion