Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01995357
Other study ID # CP244
Secondary ID
Status Completed
Phase N/A
First received November 21, 2013
Last updated February 2, 2015
Start date October 2013
Est. completion date December 2013

Study information

Verified date February 2015
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial Summary

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Have given written informed consent and signed letter of authority

2. Be at least 18 years of age and have full legal capacity

3. Have had their ileostomy/colostomy for at least 3 months

4. Have a stoma with a diameter between 15 and 36 mm

5. Be able to handle the products themselves

6. Be able to use a custom cut product

7. Normally experience faeces under the base plate at least 3 times during 2 weeks

8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut

9. Be willing to test the test products without using paste and/or ring

10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct

11. Be suitable for participation in the investigation

12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy

2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area

3. Are pregnant or breastfeeding

4. Are participating in other interventional clinical investigations or have previously participated in this investigation

5. Use irrigation during the investigation (flush the intestines with water)

6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)

7. Have a loop stoma

8. Have known hypersensitivity towards any of the test products (including adhesive remover)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

Locations

Country Name City State
Denmark Coloplast A/S Humlebæk

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of Leakage The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).
Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
10 (- 2 days) No
See also
  Status Clinical Trial Phase
Recruiting NCT04763863 - The Nordic Consensus Study
Completed NCT02974634 - Ostomy Telehealth For Cancer Survivors N/A
Completed NCT03770078 - Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma N/A
Not yet recruiting NCT04974931 - Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy N/A
Recruiting NCT04282473 - Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Recruiting NCT06320002 - Communication Intervention for Fecal Ostomy Surgery N/A
Completed NCT02544061 - NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds Phase 2
Completed NCT05466721 - Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients N/A
Completed NCT03108105 - Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy N/A
Recruiting NCT03397901 - Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study N/A
Recruiting NCT03707392 - A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching Phase 3
Completed NCT05635188 - Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection
Completed NCT05200416 - Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product N/A
Completed NCT04141566 - Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
Completed NCT04793009 - Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection
Completed NCT05289765 - Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene N/A
Not yet recruiting NCT06226753 - Impact of General Anesthesia v/s Spinal Anesthesia on ERAS Parameters in Intestinal Stoma Reversal N/A
Enrolling by invitation NCT03516916 - Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score
Completed NCT05163873 - ExPECT: Extraperitoneal End Colostomy Trial N/A
Enrolling by invitation NCT03703661 - Needle-Aspirated Compression Dressing Following Ostomy Reversal Phase 3