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Trial Outcomes & Findings for Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin (NCT NCT01245413)

NCT ID: NCT01245413

Last Updated: 2013-01-01

Results Overview

The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm\^2

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

1 hour

Results posted on

2013-01-01

Participant Flow

20 healthy volunteers and 12 colostomists were recruited to the study. The colostomist were recruited from a user data base in Denmark. The healthy volunteers were recruited by advertising in local news papers, on www.forsøgsperson.dk and by poster at"Skodsborg hotel og spa" (a fitness centre)

32 subjects were enrolled and randomised in the study.

Participant milestones

Participant milestones
Measure
SenSura Adhesive
Sensura is an already commercially available baseplate. Designed to collect output from a stoma(e.g an ileostomy and colostomy).
Athena Adhesive
Athena =the new test product. The Athena in this trails is an adhesive. The intend use is collecting output from a stoma (e.g an ileostomy and colostomy).
Sensura First,
STARTED
16
16
Sensura First,
COMPLETED
16
16
Sensura First,
NOT COMPLETED
0
0
Athena First,
STARTED
16
16
Athena First,
COMPLETED
16
16
Athena First,
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=32 Participants
Entire study population = all participlants enrolled in the study
Age Continuous
63.6 years
STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
32 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: ITT

The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm\^2

Outcome measures

Outcome measures
Measure
SenSura Adhesive
n=32 Participants
Reference adhesive which is commercially available.
Athena Adhesive
n=32 Participants
New test adhesive
Visual Inspection of Baseplate Loosening
3.77 cm^2
Standard Deviation 5.48
4.88 cm^2
Standard Deviation 4.95

Adverse Events

SenSura Adhesive

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Athena Adhesive

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Claus Hyldahl

Lægehuset, Skodsborg Strandvej 125A, 2942 Skodsborg, Denmark

Phone: 4545801331

Results disclosure agreements

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

Restriction type: GT60