Trial Outcomes & Findings for A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products (NCT NCT02517541)

Results Overview

The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

14 weeks (2 weeks baseline + 12 weeks intervention)

Results posted on

2022-11-16

Participant milestones
Measure	Test Period The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
Baseline Period (Own Product) STARTED	74
Baseline Period (Own Product) COMPLETED	73
Baseline Period (Own Product) NOT COMPLETED	1
Test Period (SenSura Mio Convex Soft) STARTED	73
Test Period (SenSura Mio Convex Soft) COMPLETED	61
Test Period (SenSura Mio Convex Soft) NOT COMPLETED	12

Reasons for withdrawal
Measure	Test Period The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
Baseline Period (Own Product) Protocol Violation	1
Test Period (SenSura Mio Convex Soft) Adverse Event	3
Test Period (SenSura Mio Convex Soft) Lack of Efficacy	2
Test Period (SenSura Mio Convex Soft) Protocol Violation	1
Test Period (SenSura Mio Convex Soft) Withdrawal by Subject	4
Test Period (SenSura Mio Convex Soft) One subjects was not suited for the tes	2

A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

Baseline characteristics by cohort
Measure	Test Period n=73 Participants The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
Age, Continuous	65.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants

Timeframe: 14 weeks (2 weeks baseline + 12 weeks intervention)

The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.

Outcome measures
Measure	Own Product n=925 baseplates The mean leakage area measured on the subjects own baseplate	SenSura Mio Convex Soft n=796 baseplates The mean leakage area measured on SenSura Mio Convex Soft baseplates
Leakage Under the Baseplate (cm^2)	9.2 cm2 Standard Deviation 9.8	6.6 cm2 Standard Deviation 8.2

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events
Measure	Own Product n=74 participants at risk The mean leakage area measured on the subjects own baseplate	SenSura Mio Convex Soft n=71 participants at risk The mean leakage area measured on SenSura Mio Convex Soft baseplates
Metabolism and nutrition disorders Hypokalemia	0.00% 0/74 • The adverse events were collected in the study period (14 weeks)	1.4% 1/71 • Number of events 1 • The adverse events were collected in the study period (14 weeks)

Other adverse events
Measure	Own Product n=74 participants at risk The mean leakage area measured on the subjects own baseplate	SenSura Mio Convex Soft n=71 participants at risk The mean leakage area measured on SenSura Mio Convex Soft baseplates
Skin and subcutaneous tissue disorders Peristomal skin dermatitis	23.0% 17/74 • Number of events 20 • The adverse events were collected in the study period (14 weeks)	35.2% 25/71 • Number of events 59 • The adverse events were collected in the study period (14 weeks)

Scientific and Regulatory affairs

Phone: +45 49111869

Restriction type: LTE60