The Influence of Baseplate Adhesive on the Degree of Leakage

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01995357
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 6
• Duration (Months): 2
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief Summary

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Condition or Disease	Intervention/Treatment	Phase
Colostomy Stoma; Ileostomy Stoma	Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First Coloplast Teast A; then Coloplast Test B There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B	Device: Coloplast Test A; Coloplast Test A is a newly developed ostomy appliance; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance.; Device: Standard product; Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Coloplast Test A; Then Standard product There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B	Device: Coloplast Test A; Coloplast Test A is a newly developed ostomy appliance; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance.; Device: Standard product; Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Coloplast Test B; Then Colopast Test A There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A	Device: Coloplast Test A; Coloplast Test A is a newly developed ostomy appliance; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance.; Device: Standard product; Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Coloplast Test B; Then Standard product There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A	Device: Coloplast Test A; Coloplast Test A is a newly developed ostomy appliance; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance.; Device: Standard product; Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Standard product; Then Coloplast Test A There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B	Device: Coloplast Test A; Coloplast Test A is a newly developed ostomy appliance; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance.; Device: Standard product; Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Standard Product, Then Coloplast test B There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A	Device: Coloplast Test A; Coloplast Test A is a newly developed ostomy appliance; Device: Coloplast Test B; Coloplast Test B is a newly developed ostomy appliance.; Device: Standard product; Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

Outcome Measures

Primary Outcome Measures

1. Degree of Leakage [10 (- 2 days)]

   The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.

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 and signed letter of authority

2. Be at least 18 years of age and have full legal capacity

3. Have had their ileostomy/colostomy for at least 3 months

4. Have a stoma with a diameter between 15 and 36 mm

5. Be able to handle the products themselves

6. Be able to use a custom cut product

7. Normally experience faeces under the base plate at least 3 times during 2 weeks

8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut

9. Be willing to test the test products without using paste and/or ring

10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct

11. Be suitable for participation in the investigation

12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy

2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area

3. Are pregnant or breastfeeding

4. Are participating in other interventional clinical investigations or have previously participated in this investigation

5. Use irrigation during the investigation (flush the intestines with water)

6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)

7. Have a loop stoma

8. Have known hypersensitivity towards any of the test products (including adhesive remover)

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Birte P Jakobsen, MD, Coloplast A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01995357
• Other Study ID Numbers: CP244
• First Posted: Nov 26, 2013
• Last Update Posted: Feb 3, 2015
• Last Verified: Feb 1, 2015

Study Results

Participant Flow

Arm/Group Title	First Coloplast Teast A; Then Coloplast Test B	First Coloplast Test A; Then Standard Product	First Coloplast Test B; Then Colopast Test A	First Coloplast Test B; Then Standard Product	First Standard Product; Then Coloplast Test A	First Standard Product, Then Coloplast Test B
Arm/Group Description	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Period Title: Period 1
STARTED	4	3	4	3	4	4
COMPLETED	4	3	4	3	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	3	4	3	4	4
COMPLETED	4	3	4	3	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	3	4	3	4	4
COMPLETED	4	3	4	3	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	3	4	3	4	4
COMPLETED	4	3	4	3	4	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	4	3	4	3	4	4
COMPLETED	2	3	3	3	4	4
NOT COMPLETED	2	0	1	0	0	0

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	Baseline data is summarized for all subjects
Overall Participants	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.0 (10.0)
Sex: Female, Male (Count of Participants)
Female	3 13.6%
Male	19 86.4%
Region of Enrollment (participants) [Number]
Denmark	22 100%

Outcome Measures

1. Primary Outcome

Title	Degree of Leakage
Description	The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
Time Frame	10 (- 2 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colostomy ,Test A	Colostomy, Training + Test A	Colostomy, Test B	Colostomy, Training + Test B	Colostomy, Standard Care (SenSura Mio)	Colostomy, Standard Care (SenSura)	Ileostomy, Test A	Ileostomy, Training + Test A	Ileostomy, Test B	Ileostomy, Training + Test B	Ileostomy, Standard Care (SenSura)
Arm/Group Description
Measure Participants	16	16	16	15	13	3	6	5	6	5	6
Mean (Standard Deviation) [units on a scale]	3.6 (5.0)	2.4 (4.2)	5.5 (5.5)	4.8 (5.1)	3.7 (6.5)	3.3 (3.2)	9.1 (5.2)	9.7 (5.7)	11.5 (5.3)	12.9 (5.6)	8.5 (5.1)

Adverse Events

Time Frame	Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
Arm/Group Title	Test A + Training Test A		Test B + Training Test B		Standard Care
Arm/Group Description	Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A. Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one.		Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B. Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one.		Standard care was used only during part one of the study. i.e. for one period only.
All Cause Mortality
	Test A + Training Test A		Test B + Training Test B		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test A + Training Test A		Test B + Training Test B		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Test A + Training Test A		Test B + Training Test B		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/22 (36.4%)		9/22 (40.9%)		3/22 (13.6%)
Eye disorders
Planned operation, non-study related	0/22 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	1
Gastrointestinal disorders
Diarrhea or constipation	1/22 (4.5%)	3	0/22 (0%)	0	0/22 (0%)	0
Infections and infestations
Cold or influenza	2/22 (9.1%)	2	0/22 (0%)	0	1/22 (4.5%)	1
Herpes Zoster	1/22 (4.5%)	1	0/22 (0%)	0	0/22 (0%)	0
Musculoskeletal and connective tissue disorders
Pain, leg	0/22 (0%)	0	1/22 (4.5%)	1	0/22 (0%)	0
Skin and subcutaneous tissue disorders
Peristomal skin irritation/broken skin/stomal bleeding	6/22 (27.3%)	8	9/22 (40.9%)	13	1/22 (4.5%)	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.