Investigation of the Performance of Ostomy Base Plate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01103466
First received: April 13, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.


Condition Intervention
Ileostomy - Stoma
Device: Atlas
Device: SenSura
Device: Conform 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Leakage Under the Base Plate [ Time Frame: At every change of base plate ] [ Designated as safety issue: No ]
    Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.


Enrollment: 41
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: New ostomy appliance (Atlas)
Atlas= new base plate. Due to company confidentiality the product is just called Atlas and this is not short for any other names
Device: Atlas
Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
Other Name: ostomy appliance
Active Comparator: SenSura
Commercially available ostomy appliance
Device: SenSura
SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
Other Name: ostomy appliance
Active Comparator: Conform 2
Commercially available ostomy appliance
Device: Conform 2
Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
Other Name: Ostomy appliance

Detailed Description:

Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems.

The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market.

The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home.

80 healthy participants with an ileostomy will be included in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have given written Informed Consent
  2. Are at least 18 years old
  3. Had their ileostomy for minimum 3 months with a size between 20-40 mm
  4. Have mental capacity to understand study guidelines and questionnaires
  5. Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
  6. Experience leakage under the base plate at least one a week
  7. Are currently using a flat 2-piece base plate with mechanical coupling
  8. Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study

    -

Exclusion Criteria:

  1. Pregnant or breast-feeding
  2. Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
  3. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  4. Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
  5. Currently using a convex system
  6. Participating in other clinical studies or have previously participated in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103466

Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Lis H Poulsen, MD Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01103466     History of Changes
Other Study ID Numbers: CP204OC
Study First Received: April 13, 2010
Results First Received: January 9, 2012
Last Updated: February 22, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Coloplast A/S:
Ileostomy base plate

ClinicalTrials.gov processed this record on October 01, 2014