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

NCT ID: NCT01782196

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

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.

Conditions

Ileostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Type A Pouch followed by Type B pouch

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

Group Type: EXPERIMENTAL

Enhanced one piece drainable pouch with Type A mouldable adhesive

Intervention Type: DEVICE

Enhanced one piece drainable pouch with Type B mouldable adhesive

Intervention Type: DEVICE

Type B Pouch followed by Type A pouch

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

Group Type: EXPERIMENTAL

Enhanced one piece drainable pouch with Type A mouldable adhesive

Intervention Type: DEVICE

Enhanced one piece drainable pouch with Type B mouldable adhesive

Intervention Type: DEVICE

Interventions

Enhanced one piece drainable pouch with Type A mouldable adhesive

Intervention Type: DEVICE

Enhanced one piece drainable pouch with Type B mouldable adhesive

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princess of Wales Hospital

Bridgend, Mid Glam, United Kingdom

Wrexham Maelor Hospital

Wrexham, North Wales, United Kingdom

Musgrove Park Hospital

Taunton, Somerset, United Kingdom

Manor Hospital

Walsall, West Midlands, United Kingdom

Homerton University Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CC-0512-12-U366

Identifier Type: -

Identifier Source: org_study_id