A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy

Not Applicable

Terminated

Interventions: Device: Enhanced one piece drainable pouch with Type A mouldable adhesive
Device: Enhanced one piece drainable pouch with Type B mouldable adhesive

Brief Summary: Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.

Recruitment & Eligibility

Inclusion Criteria

Subjects who provide written informed consent.
Subjects who have an ileostomy and be over 18 years of age.
Subjects who are currently using a one piece drainable pouch.
Subjects who have unbroken peri-stomal skin (healthy normal skin defined as "normal unbroken skin with certain variations normal for this subject" to L1 on the SACs Instrument Scale).
Subjects with a stoma considered 'normal' in appearance in accordance with the stoma, colour, moisture and structure rating scales.
Subjects who are willing to attend clinic for a maximum of 5 separate occasions for scheduled visits.
Subjects who are willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device.
Subjects who other than their ileostomy considered to have a healthy/stable health status.
Subjects who have good manual dexterity and be able to take care of their stoma independently, or have a consistent care provider.
Subjects who are willing and able to complete a diary card for the duration of the study.

Exclusion Criteria

Subjects with a history of sensitivity to any one of the ostomy products or the components being studied.
Subjects with stoma duration of less than 3 months.
Subjects who currently use a belt with their usual appliance.
Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
Subjects who require convexity or other skin fillers (pastes, rings, seals) to even undulations of the skin.
Subjects undergoing chemotherapy or radiotherapy.
Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study.

Arm && Interventions

Group	Intervention	Description
Type A Pouch followed by Type B pouch	Enhanced one piece drainable pouch with Type A mouldable adhesive	Enhanced one piece drainable pouch with Type A mouldable adhesive for Stage 1 and 2 followed by pouch with Type B mouldable adhesive for Stage 3
Type A Pouch followed by Type B pouch	Enhanced one piece drainable pouch with Type B mouldable adhesive	Enhanced one piece drainable pouch with Type A mouldable adhesive for Stage 1 and 2 followed by pouch with Type B mouldable adhesive for Stage 3
Type B Pouch followed by Type A pouch	Enhanced one piece drainable pouch with Type A mouldable adhesive	Enhanced one piece drainable pouch with Type B mouldable adhesive for Stage 1 and 2 followed by pouch with Type A mouldable adhesive for Stage 3
Type B Pouch followed by Type A pouch	Enhanced one piece drainable pouch with Type B mouldable adhesive	Enhanced one piece drainable pouch with Type B mouldable adhesive for Stage 1 and 2 followed by pouch with Type A mouldable adhesive for Stage 3

Primary Outcome Measures

Name	Time	Method
Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions	59 days	The primary objective of this study is to evaluate the safety of the enhanced one piece drainable pouch with a mouldable skin barrier wafer and two alternate adhesives in subjects with an ileostomy.

Secondary Outcome Measures

Name	Time	Method
Performance	59 days	Performance will be evaluated by comparing the following categories to the subject's usual pouching system Wear time Adhesion Ease of Use Mouldability Comfort and flexibility Security Skin protection Wafer seal integrity Undermining Filter performance Accessory usage At the end of the study a comparative assessment of the subject's usual pouching system and the study pouch will be made.

Locations (5): Manor Hospital
🇬🇧
Walsall, West Midlands, United Kingdom
Princess of Wales Hospital
🇬🇧
Bridgend, Mid Glam, United Kingdom
Wrexham Maelor Hospital
🇬🇧
Wrexham, North Wales, United Kingdom
Homerton University Hospital
🇬🇧
London, United Kingdom
Musgrove Park Hospital
🇬🇧
Taunton, Somerset, United Kingdom