Clinical trial NCT01782196: A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions
timeFrame: 59 days
Secondary outcomes:
measure: Performance
timeFrame: 59 days
Other outcomes:
Locations:
city: Bridgend
country: United Kingdom
facility: Princess of Wales Hospital
state: Mid Glam
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
state: North Wales
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
state: Somerset
city: Walsall
country: United Kingdom
facility: Manor Hospital
state: West Midlands
city: London
country: United Kingdom
facility: Homerton University Hospital
Study officials:
References: