Colostomy Stoma Clinical Trial
Official title:
The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy
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 |
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Coloplast A/S | Humlebæk |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
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 |
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 |