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

This study has been terminated.
(Leakage)
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01782196
First received: December 19, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Ileostomy
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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions [ Time Frame: 59 days ] [ Designated as safety issue: Yes ]
    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:
  • Performance [ Time Frame: 59 days ] [ Designated as safety issue: No ]

    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.



Enrollment: 13
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782196

Locations
United Kingdom
Princess of Wales Hospital
Bridgend, Mid Glam, United Kingdom, CF31 1RQ
Wrexham Maelor Hospital
Wrexham, North Wales, United Kingdom, LL13 7TD
Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
Manor Hospital
Walsall, West Midlands, United Kingdom, WS2 9PS
Homerton University Hospital
London, United Kingdom, E9 6SR
Sponsors and Collaborators
ConvaTec Inc.
  More Information

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01782196     History of Changes
Other Study ID Numbers: CC-0512-12-U366
Study First Received: December 19, 2012
Last Updated: July 2, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on July 29, 2014