A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy (U366)

Convatec

Status: Terminated

Conditions: Ileostomy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01782196

CC-0512-12-U366

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

Type A Pouch followed by Type B pouch

Experimental group

Description:

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

Treatment:

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

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

Type B Pouch followed by Type A pouch

Experimental group

Description:

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

Treatment:

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

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