Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

The aim of the investigation was to investigate the performance and safety of a new ostomy product.

Study Overview

• Status: Completed
• Conditions: Stoma Ileostomy
• Intervention / Treatment: Device: Coloplast test product; Device: SenSura Convex Light

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Søborg, Denmark
    • TFS
• France
  • Dijon cedex, France, 21079
    • Hôpital du Bocage
  • Libourne cedex, France, 33505
    • Hôpital Robert Boulin
  • Lille cedex, France, 59037
    • Hopital Claude Huriez
  • Marseille, France, 13015
    • Hopital Nord
  • Paris, France, 75020
    • Hôpital Tenon
  • Paris, France, 75014
    • Hopital Cochin
  • Pessac cedex, France, 33604
    • Hopital De Haut Leveque
  • Poitiers Cedex, France, 86021
    • CHRU La Milétrie
• Germany
  • Aachen, Germany
    • BB medica medizinisches
  • Augsburg, Germany
    • Sanitätshause reinhold hilscher e.K.
  • Bad Staffelstein, Germany
    • Patientenberatung Strack e.K.
  • Berlin, Germany
    • Pro-samed Santitätshaus
  • Burgdorf, Germany
    • SIEWA Coloplast Homecare
  • Freising, Germany
    • SIEWA Coloplast Homecare
  • Leinfelden-echterdingen, Germany
    • SIEWA Coloplast Homecare
  • Leipzig, Germany
    • Schürmaier GmbH &Co
  • Passau, Germany
    • Sanitätshaus Fürst GmbH
  • Saulgrub, Germany
    • SIEWA Coloplast Homecare
  • Töppeln, Germany
    • Sanitäts- und gesundheitshaus Carqueville GmbH
  • Zwickau, Germany
    • Alippi GmbH
• Norway
  • Larvik, Norway
    • Sykpleierklinikken
• United Kingdom
  • Boston, United Kingdom
    • Pilgrim Hospital
  • Cambridge, United Kingdom, CB20QQ
    • Addenbrookes
  • Gloucestershire, United Kingdom, GL53/AI
    • Cheltenham General Hospital
  • Lincoln, United Kingdom, LN25QY
    • Lincon Country hospital
  • London, United Kingdom, W68RF
    • Charing Cross Hospital
  • Northamptonshire, United Kingdom, NN168UZ
    • Kettering General Hospital
  • Suffolk, United Kingdom, IP332QZ
    • West Suffolk 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:

1. Are at least 18 years of age and have full legal capacity.
2. Has had an ileostomy for at least 3 months.
3. Has used a convex ostomy product for the last month.
4. Has given signed informed consent.
5. Has experienced seeping under the baseplate at least three times during the last two weeks.
6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria:

1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
2. Are pregnant or breastfeeding.
3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
6. Are currently participating in another clinical intervention study or have previously participated in this one.
7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
8. Has known hypersensitivity toward the test product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First Coloplast test product; The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light	Device: Coloplast test product; The Coloplast test product is a newly developed ostomy appliance; Device: SenSura Convex Light; The comparator product is SenSura Convex Light, which is CE-marked and commercially available.; Other Names: SenSura
Experimental: First SenSura Convex Light; The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product	Device: Coloplast test product; The Coloplast test product is a newly developed ostomy appliance; Device: SenSura Convex Light; The comparator product is SenSura Convex Light, which is CE-marked and commercially available.; Other Names: SenSura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).	28 +/- 3 days

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Director: Daniel Carter, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CP232