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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01782196
Other study ID # CC-0512-12-U366
Secondary ID
Status Terminated
Phase N/A
First received December 19, 2012
Last updated July 2, 2013
Start date October 2012
Est. completion date March 2013

Study information

Verified date July 2013
Source ConvaTec Inc.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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 information / eligibility

Status Terminated
Enrollment 13
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
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.

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


Related Conditions & MeSH terms


Intervention

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

Enhanced one piece drainable pouch with Type B mouldable adhesive


Locations

Country Name City State
United Kingdom Princess of Wales Hospital Bridgend Mid Glam
United Kingdom Homerton University Hospital London
United Kingdom Musgrove Park Hospital Taunton Somerset
United Kingdom Manor Hospital Walsall West Midlands
United Kingdom Wrexham Maelor Hospital Wrexham North Wales

Sponsors (1)

Lead Sponsor Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 No
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