A Clinical Investigation of New Ostomy Appliances

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01523756
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

Condition or Disease	Intervention/Treatment	Phase
Leakage	Device: test product 1: new ostomy base plate with Coloplast as manufacturer; Device: test product 2: new ostomy base plate with Coloplast as manufacturer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: test product 1 first own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1	Device: test product 1: new ostomy base plate with Coloplast as manufacturer; test product 1 is tested first
Experimental: test product 2 first own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2	Device: test product 2: new ostomy base plate with Coloplast as manufacturer; test product 2 is tested first

Outcome Measures

Primary Outcome Measures

1. Leakage Under the Base Plate Using a 24-point Scale [Each product will be tested 2 weeks]

   Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Age > 18 years.

2. Have had an ileostomy for more than 3 months.

3. Have used convex products for the last 1 month.

4. Has given written Informed Consent.

5. Have an ileostomy with a diameter between 15 and 33 mm.

6. Have inward peristomal area

Exclusion Criteria:

1. Have loop ostomy

2. Pregnant or breastfeeding.

3. Known allergy towards any of the product components or ingredients.

4. Currently receiving or have within the last 2 months received radio- and/or chemotherapy.

5. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.

6. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coloplast A/S	Humlebaek		Denmark	3050

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: NCT01523756
• Other Study ID Numbers: CP226
• First Posted: Feb 1, 2012
• Last Update Posted: Mar 10, 2014
• Last Verified: Jan 1, 2014

Study Results

Participant Flow

Recruitment Details	The subjects were recruited through the Coloplast database.

Arm/Group Title	Own Product (Baseline) - Test Product 1 - Test Product 2	Own Product (Baseline) - Test Product 2 - Test Product 1
Arm/Group Description	own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1	own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
Period Title: Baseline Period
STARTED	11	9
COMPLETED	11	8
NOT COMPLETED	0	1
Period Title: Baseline Period
STARTED	11	8
COMPLETED	10	8
NOT COMPLETED	1	0
Period Title: Baseline Period
STARTED	10	8
COMPLETED	10	7
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (10.8)
Sex: Female, Male (Count of Participants)
Female	12 60%
Male	8 40%

Outcome Measures

1. Primary Outcome

Title	Leakage Under the Base Plate Using a 24-point Scale
Description	Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
Time Frame	Each product will be tested 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Product 1	Test Product 2	Baseline
Arm/Group Description	own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1	own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2	Data collected on own product- All subjects collected baseline data on own product in the first period.
Measure Participants	19	18	20
Measure degree of leakage on the baseplate	111	111	113
Mean (Standard Deviation) [units on a scale]	4.5 (5.3)	3.3 (4.3)	4.4 (4.7)

Adverse Events

Arm/Group Title	Test Product 1		Test Product 2		Baseline
Arm/Group Description	own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1		own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2		Data collected on own product- All subjects collected baseline data on own product in the first period.
All Cause Mortality
	Test Product 1		Test Product 2		Baseline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test Product 1		Test Product 2		Baseline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		1/20 (5%)
Gastrointestinal disorders
Gastroenterit	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Test Product 1		Test Product 2		Baseline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/19 (42.1%)		6/18 (33.3%)		1/20 (5%)
Gastrointestinal disorders
Gastroenterit	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1
General disorders
Nausea	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1
Infections and infestations
febrilia	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1
Herpes on the back of the thigh	1/19 (5.3%)	1	0/18 (0%)	0	0/20 (0%)	0
candidiacis on labia	1/19 (5.3%)	1	0/18 (0%)	0	0/20 (0%)	0
Nervous system disorders
sclerose attack	1/19 (5.3%)	1	0/18 (0%)	0	0/20 (0%)	0
Renal and urinary disorders
Urin retension	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1
Cystitis	1/19 (5.3%)	1	0/18 (0%)	0	1/20 (5%)	1
pain in bladder/Tenesmi	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1
Reproductive system and breast disorders
elevated prostataspecific antigen	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1
Respiratory, thoracic and mediastinal disorders
cold	0/19 (0%)	0	2/18 (11.1%)	2	0/20 (0%)	0
Skin and subcutaneous tissue disorders
Skin irritation (peristomal)	3/19 (15.8%)	3	2/18 (11.1%)	2	0/20 (0%)	0
Bleeding peristomal skin	0/19 (0%)	0	1/18 (5.6%)	1	0/20 (0%)	0
Itchy peristomal skin	3/19 (15.8%)	3	1/18 (5.6%)	1	0/20 (0%)	0
skin irritation	0/19 (0%)	0	0/18 (0%)	0	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.