NCT01782196

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

December 19, 2012

Last Update Submit

July 2, 2013

Conditions

Ileostomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Performance

    59 days

Study Arms (2)

Type A Pouch followed by Type B pouch

EXPERIMENTAL

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

Type B Pouch followed by Type A pouch

EXPERIMENTAL

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

Interventions

Enhanced one piece drainable pouch with Type A mouldable adhesiveDEVICE
Type A Pouch followed by Type B pouchType B Pouch followed by Type A pouch
Enhanced one piece drainable pouch with Type B mouldable adhesiveDEVICE
Type A Pouch followed by Type B pouchType B Pouch followed by Type A pouch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Princess of Wales Hospital

Bridgend, Mid Glam, CF31 1RQ, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, North Wales, LL13 7TD, United Kingdom

Location

Musgrove Park Hospital

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Manor Hospital

Walsall, West Midlands, WS2 9PS, United Kingdom

Location

Homerton University Hospital

London, E9 6SR, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

February 1, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

GB(5)