Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation

Not Applicable

Completed

• Conditions: Stoma Ileostomy; Stoma Colostomy
• Interventions: Device: Heylo

• Registration Number: NCT05135754
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-22
• Study Start: 2021-11-25
• Study First Posted: 2021-11-26
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Results First Submitted: 2023-08-29
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Results First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test product - new supporting ostomy product and support service	Heylo	The arm includes the newly developed supporting ostomy product (leakage notification system Heylo) used together with a support service

Primary Outcome Measures

Name	Time	Method
Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks	Baseline (Day 0) and Final Evaluation (Week 12)	Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?

Secondary Outcome Measures

Name	Time	Method
Patient Self-management	Baseline (Day 0) and Final Evaluation (Week 12)	Patient Activation Measure (PAM) score The Patient Activation Measurement (PAM) is scored on a scale ranging from 0 to 100.; Individuals who score high on this instrument typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so.
Ostomy Leakage Impact Tool - 'Coping and in Control' Domain	Baseline (Day 0) and Final Evaluation (Week 12)	Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
Health Related Quality of Life	Baseline (Day 0) and Final Evaluation (Week 12)	The EQ-5D-5L instrument consists of five dimensions with five predetermined levels of response that is used to generate a health state profile, which then can be assigned a summary index score. Translation of health states and index scores are based on the specific value set for United Kingdom.; The index scores based on the value set for United Kingdom ranges from -0.285 to 1.; Index score of -0.285 is the worst health state. Index score of 1 is the best health state.
Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain	Baseline (Day 0) and Final Evaluation (Week 12)	Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
EQ-5D-5L Visual Analogue Scale (VAS)	Baseline (Day 0) and Final Evaluation (Week 12)	Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).
Ostomy Leakage Impact Tool - 'Emotional Impact' Domain	Baseline (Day 0) and Final Evaluation (Week 12)	Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.

Trial Locations

Locations (10)

Southmead/North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Chelsea & Westminster Hospital; 🇬🇧 Chelsea, United Kingdom

Devon/Royal Devon and Exeter NHS Foundation Trust; 🇬🇧 Exeter, United Kingdom

Norfolk/James Paget University Hospitals NHS Foundation Trust; 🇬🇧 Great Yarmouth, United Kingdom

Leeds/Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

Illingworth; 🇬🇧 Manchester, United Kingdom

Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle, United Kingdom

Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital; 🇬🇧 Peterborough, United Kingdom

Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital; 🇬🇧 Preston, United Kingdom

Middlesbrough/South Tees NHS trust, James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom