Recruitment

Recruitment Status
Completed

Inclusion Criterias

Have had a colostomy for at least 1 year.
Are willing to comply with investigation procedures.
Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
...
Have had a colostomy for at least 1 year.
Are willing to comply with investigation procedures.
Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
Be in the age of 45 to 75 years of age both extremes included.
Has a colostomy with a diameter up to (≤) 40 mm.
Have a BMI between 20-30 kg/m2.
Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
Have given written informed consent.
Have mental capacity to understand the study guidelines and questionnaires.

Exclusion Criterias

Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
Participating in other clinical studies or have previously participated in this test.
Are pregnant or breastfeeding.
...
Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
Participating in other clinical studies or have previously participated in this test.
Are pregnant or breastfeeding.
Received radio- and/or chemotherapy within the last two months.
Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
Have dermatological problems.
Be a daily user of a convex base-plate.

Summary

Conditions
Colostomy Stoma
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)

Participation Requirements

Age
Between 45 years and 75 years
Gender
Both males and females

Inclusion Criterias

Have had a colostomy for at least 1 year.
Are willing to comply with investigation procedures.
Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
...
Have had a colostomy for at least 1 year.
Are willing to comply with investigation procedures.
Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
Be in the age of 45 to 75 years of age both extremes included.
Has a colostomy with a diameter up to (≤) 40 mm.
Have a BMI between 20-30 kg/m2.
Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
Have given written informed consent.
Have mental capacity to understand the study guidelines and questionnaires.

Exclusion Criterias

Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
Participating in other clinical studies or have previously participated in this test.
Are pregnant or breastfeeding.
...
Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
Participating in other clinical studies or have previously participated in this test.
Are pregnant or breastfeeding.
Received radio- and/or chemotherapy within the last two months.
Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
Have dermatological problems.
Be a daily user of a convex base-plate.

Tracking Information

NCT #
NCT01918085
Collaborators
Not Provided
Investigators
  • Principal Investigator: Tonny Karlsmark, MD Bispebjerg Hospital, Denmark
  • Tonny Karlsmark, MD Bispebjerg Hospital, Denmark