Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01517178
• Collaborator: (none)
• Enrollment: 33
• Locations: 11
• Arms: 2
• Duration (Months): 1
• Patients Per Site: 3
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

Condition or Disease	Intervention/Treatment	Phase
Leakage; Skin Condition	Device: New ostomy base plate (SS); Device: Standard Care base plate	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Care base plate Standard care are the participants own product and can have several manufacture and brand names	Device: Standard Care base plate; The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
Experimental: New ostomy base plate (SS) SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name	Device: New ostomy base plate (SS); The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

Outcome Measures

Primary Outcome Measures

1. Degree of Output Under the Base Plate (Leakage). [Each test product was assessed for 2 weeks.]

   Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Have given written Informed Consent

2. Is at least 18 years old

3. Has the mental capacity to understand the study guidelines and questionnaires

4. Has had their ileostomy for at least 3 months

5. Has an ileostomy with a diameter between 19-40 mm

6. Is currently using a flat 2-piece product with with mechanical coupling

7. Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)

8. Has experienced leakage under the base plate at least once a week over the last 2 weeks

Exclusion Criteria:

1. Is pregnant or breast-feeding

2. Currently receiving or has within the past 2 months received radio- and/or chemotherapy

3. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)

4. Is currently using a convex base plate

5. Participating in other clinical studies or has previously participated in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sygehus Sønderjylland i Aabenraa	Aabenraa		Denmark	6200
2	Bispebjerg Hospital	Copenhagen		Denmark	2400
3	Hvidovre Hospital	Hvidovre		Denmark	2650
4	Odense Universitetshospital	Odense		Denmark	5000
5	Hôpital Nord	Marseille		France	13015
6	Hôpital Hôtel Dieu de Nantes	Nantes cedex 1		France	44093
7	Hôpital Lariboisière	Paris cedex 10		France	75475
8	CHRU La Milétrie	Poitiers cedex		France	86021
9	Hôpital de Pontchaillou, CHRU de Rennes	Rennes cedex 9		France	35033
10	Sanitätshaus Fürst GmbH	Passau		Germany	94032
11	Landspitali University Hospital	Reykjavik		Iceland	108

Sponsors and Collaborators

• Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01517178
• Other Study ID Numbers: CP215OC
• First Posted: Jan 25, 2012
• Last Update Posted: Mar 13, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Skin Diseases

Study Results

Participant Flow

Pre-assignment Detail	A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.

Arm/Group Title	Standard Care - New Ostomy Base Plate	New Ostomy Base Plate - Standard Care
Arm/Group Description	Subjects first test Standard Care then New ostomy base plate.	Subjects first test New ostomy base plate then Standard Care.
Period Title: Period 1
STARTED	16	11
COMPLETED	12	6
NOT COMPLETED	4	5
Period Title: Period 1
STARTED	11	6
COMPLETED	5	4
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Intention-to-treat Analysis Set
Arm/Group Description
Overall Participants	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.9 (12.8)
Sex: Female, Male (Count of Participants)
Female	14 51.9%
Male	13 48.1%
Region of Enrollment (participants) [Number]
France	6 22.2%
Denmark	19 70.4%
Iceland	1 3.7%
Germany	1 3.7%

Outcome Measures

1. Primary Outcome

Title	Degree of Output Under the Base Plate (Leakage).
Description	Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
Time Frame	Each test product was assessed for 2 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care Base Plate	New Ostomy Base Plate
Arm/Group Description
Measure Participants	22	22
Measure Baseplates	122	104
Mean (Standard Deviation) [units on a scale]	4.6 (3.5)	6.5 (5.0)

Adverse Events

Arm/Group Title	Standard Care Base Plate		New Ostomy Base Plate
Arm/Group Description	Safety population includes subjects allocated to test period (no run-in period)		Safety population includes subjects allocated to run-in period and test period.
All Cause Mortality
	Standard Care Base Plate		New Ostomy Base Plate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care Base Plate		New Ostomy Base Plate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/30 (3.3%)
Infections and infestations
Infection in parastomal prosthetic mesh	0/21 (0%)	0	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Standard Care Base Plate		New Ostomy Base Plate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		13/30 (43.3%)
Skin and subcutaneous tissue disorders
Peristomal skin irritation	0/21 (0%)	0	5/30 (16.7%)	5
Adhesive issue	0/21 (0%)	0	9/30 (30%)	9
Lack of effectiveness	0/21 (0%)	0	1/30 (3.3%)	1

Limitations/Caveats

Early termination leading to small number of subjects analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.