Performance Study of Newly Developed Ostomy Products

NCT01513330 | Completed Phase 4 Results

• 1 other identifier: CP219
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Conditions

Stoma Colostomy

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)

  Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.

  14 days

Study Arms (2)

First Standard Care, then SenSura Mio

EXPERIMENTAL

Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio

Device: SenSura Mio; Device: Standard Care

First SenSura Mio, then Standard Care

EXPERIMENTAL

Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)

Device: SenSura Mio; Device: Standard Care

Interventions

SenSura Mio DEVICE

Ostomy product - 1 piece closed bag

First SenSura Mio, then Standard Care; First Standard Care, then SenSura Mio

Standard Care DEVICE

Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

First SenSura Mio, then Standard Care; First Standard Care, then SenSura Mio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent.
• Be at least 18 years of age and have full legal capacity.
• Have experienced leakage under the base plate at least once a week over the last two weeks.
• Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
• Have a colostomy with a diameter between 20 and 45 mm.
• Have had their ostomy for at least three months.
• Currently use a 1-piece flat product with closed bag.
• Use minimum 1 product per day.
• Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

You may not qualify if:

• Use irrigation during the study (flush the stoma with water).
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
• Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
• Are pregnant or breastfeeding.
• Participating in other interventional clinical investigations or have previously participated in this investigation.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Publicare

Cologne, Køln, Germany

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 3595

Study Officials

• Wenche Sundberg, stoma nurse

  Diakonhjemmet Sykhus, Oslo

  PRINCIPAL INVESTIGATOR

• Merete Bjørke, Stoma Nurse

  St. Olavs Hopsital

  PRINCIPAL INVESTIGATOR

• Vigids Dagsland, Stoma Nurse

  Haugesund Sykhus

  PRINCIPAL INVESTIGATOR

• Randi Melum, Stoma Nurse

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 20, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 9, 2014
• Results First Posted: January 9, 2014

Record last verified: 2013-11

Locations

DE (1)