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

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.

Study Overview

• Status: Terminated
• Conditions: Ileostomy
• Intervention / Treatment: Device: Enhanced one piece drainable pouch with Type A mouldable adhesive; Device: Enhanced one piece drainable pouch with Type B mouldable adhesive

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E9 6SR
    • Homerton University Hospital
  • Mid Glam
    • Bridgend, Mid Glam, United Kingdom, CF31 1RQ
      • Princess of Wales Hospital
  • North Wales
    • Wrexham, North Wales, United Kingdom, LL13 7TD
      • Wrexham Maelor Hospital
  • Somerset
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Musgrove Park Hospital
  • West Midlands
    • Walsall, West Midlands, United Kingdom, WS2 9PS
      • Manor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Enhanced one piece drainable pouch with Type A mouldable adhesive; Device: Enhanced one piece drainable pouch with Type B mouldable adhesive
Experimental: 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	Device: Enhanced one piece drainable pouch with Type A mouldable adhesive; Device: Enhanced one piece drainable pouch with Type B mouldable adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions	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.	59 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	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.	59 days

Collaborators and Investigators

• Sponsor: ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CC-0512-12-U366