Clinical trial NCT05135754: Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation
Official title: Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Stoma Colostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.

To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.


Eligibility criteria: Inclusion Criteria:

1. Have provide written informed consent.
2. Be at least 18 years of age and have full capacity.
3. Have had their stoma for less than 9 months.
4. Have intact skin on the peristomal area (assessed by investigator)
5. Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
6. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
7. Is willing to refrain from use of paste and protective sheets.
8. Have a smartphone applicable for the HeyloTM app.
9. Have been self-managing stoma appliance for at least 14 days.
10. Are able to follow study procedures for 3 months (assessed by investigator)
11. Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.

Exclusion Criteria:

1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
2. Is breastfeeding.
3. Is pregnant based on urine pregnancy test.
4. Enrolled in another current research study or have previously participated in this investigation.
5. Has known hypersensitivity towards any of the products used in the investigation.
6. Is using/have a pacemaker.
7. Has a complicated stoma at baseline (dehiscence/prolapse/hernia)
8. Has limited life expectancy or receive palliative care.
9. Has stage 4 cancer.
10. Having more than one stoma synchronously
11. Having ongoing non-healed abdominal wounds
12. Reoperation / stoma reversal planned during the study period.

Primary outcomes:
measure: Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
Secondary outcomes:
measure: Patient Self-management
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
measure: Ostomy Leakage Impact Tool - 'Emotional Impact' Domain
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
measure: Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
measure: Ostomy Leakage Impact Tool - 'Coping and in Control' Domain
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
measure: Health Related Quality of Life
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
measure: EQ-5D-5L Visual Analogue Scale (VAS)
timeFrame: Baseline (Day 0) and Final Evaluation (Week 12)
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Southmead/North Bristol NHS Trust
city: Chelsea
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: Exeter
country: United Kingdom
facility: Devon/Royal Devon and Exeter NHS Foundation Trust
city: Great Yarmouth
country: United Kingdom
facility: Norfolk/James Paget University Hospitals NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds/Leeds Teaching Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: Illingworth
city: Middlesbrough
country: United Kingdom
facility: Middlesbrough/South Tees NHS trust, James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Peterborough
country: United Kingdom
facility: Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital
city: Preston
country: United Kingdom
facility: Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital
Study officials:
affiliation: Newcastle-upon-Tyne Hospitals NHS Trust
name: Richard Brady
role: PRINCIPAL_INVESTIGATOR
References: