Trial Outcomes & Findings for Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort (NCT NCT01243294)

NCT ID: NCT01243294

Last Updated: 2011-10-07

Results Overview

Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 56 participants
• Primary outcome timeframe: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
• Results posted on: 2011-10-07

Participant Flow

Subjects recruited from a user database in Denmark and through six hospital sites in France between august and november 2010

56 subject where enrolled, however two subjects did not comply to the in- and exclusion criteria and was hence terminated before testing any devices

Participant milestones

Measure	SenSura First, Then SS SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SS First, Then SenSura SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
First Intervention (10 Days +/- 2 Days) STARTED	28	26
First Intervention (10 Days +/- 2 Days) COMPLETED	28	26
First Intervention (10 Days +/- 2 Days) NOT COMPLETED	0	0
Second Intervention (10 Days +/- 2 Days) STARTED	28	26
Second Intervention (10 Days +/- 2 Days) COMPLETED	28	26
Second Intervention (10 Days +/- 2 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

Baseline characteristics by cohort

Measure	Entire Study Population n=54 Participants Includes groups randomized to receive SS (new ostomy bag)first and SenSura first
Age Continuous	70.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment Denmark	39 participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants

PRIMARY outcome

Timeframe: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day

Population: Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device

Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point

Outcome measures

Measure	New Adhesive SS n=975 Base plates SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SenSura n=1046 Base plates CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
Leakage (Percent of All Base Plates With Leakage)	27 Percent of Base plates	30 Percent of Base plates

SECONDARY outcome

Timeframe: During the investigation ~ 24 days per subject

Population: As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT

Safety is evaluated by adverse events occuring continues while the subjects are testing the devices

Outcome measures

Measure	New Adhesive SS n=54 Participants SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SenSura n=54 Participants CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
Adverse Events	1 Adverse events	2 Adverse events

SECONDARY outcome

Timeframe: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product

Population: As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT

Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.

Unit of measure is: Percentage of participants answering 'very good'

Outcome measures

Measure	New Adhesive SS n=54 Participants SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SenSura n=54 Participants CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
Security (Subjects Own Assessment)	48 Percent of participants	28 Percent of participants

SECONDARY outcome

Timeframe: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product

Population: As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT

Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.

Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.

Unit of measure is: Percentage of participants answering 'very easy' and 'easy'

Outcome measures

Measure	New Adhesive SS n=54 Participants SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SenSura n=54 Participants CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
Handling at Appliance (Subjects Own Assessment)	89 Percent of participants	91 Percent of participants

SECONDARY outcome

Timeframe: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product

Population: As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT

Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.

Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.

Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'

Outcome measures

Measure	New Adhesive SS n=54 Participants SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SenSura n=54 Participants CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
Comfort (Subjects Own Assessment)	93 Percent of participants	67 Percent of participants

SECONDARY outcome

Timeframe: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day

Population: As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT

Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.

Outcome measures

Measure	New Adhesive SS n=975 Base plates SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.	SenSura n=1046 Base plates CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test.
Wear Time (Registered by Subject When Applying and Removing a Product)	11.46 Hours Standard Deviation 7.07	11.41 Hours Standard Deviation 6.41

Adverse Events

SenSura

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SS (New Ostomy Bag)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SenSura n=54 participants at risk Base plates applied 1 till 6 times a day	SS (New Ostomy Bag) n=54 participants at risk Base plates applied 1 till 6 times a day SS = new ostomy bag
Skin and subcutaneous tissue disorders Redness and skin damage	1.9% 1/54 • Number of events 1 • AE data where collected from inclusion to the two test periods where completed (~24 days)	0.00% 0/54 • AE data where collected from inclusion to the two test periods where completed (~24 days)
Skin and subcutaneous tissue disorders Peripheral lesions from 5 cm (peripheral edges)	1.9% 1/54 • Number of events 1 • AE data where collected from inclusion to the two test periods where completed (~24 days)	0.00% 0/54 • AE data where collected from inclusion to the two test periods where completed (~24 days)
Skin and subcutaneous tissue disorders Redness on skin 0-2 cm from stoma edge	0.00% 0/54 • AE data where collected from inclusion to the two test periods where completed (~24 days)	1.9% 1/54 • Number of events 1 • AE data where collected from inclusion to the two test periods where completed (~24 days)

Additional Information

Pia Nordmand, Clinical Trial Manager

Coloplast A/S

Phone: +4549113250

Email: dkpialn@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place