Investigation of the Performance of Ostomy Base Plate

A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Atlas; Device: SenSura; Device: Conform 2

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Ostomy appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leakage Under the Base Plate	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.	At every change of base plate

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Lis H Poulsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 14, 2010

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ileostomy base plate
• Other Study ID Numbers: CP204OC