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OpenTrials
Completed

NCT Number: NCT05135754

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

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.

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Key information

Conditions

Stoma Ileostomy Stoma Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southmead/North Bristol NHS Trust, Bristol, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Heylo

Device

Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days.

Primary outcomes

  1. Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks

    Time frame: 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 outcomes

  1. Patient Self-management

    Time frame: 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.

  2. Ostomy Leakage Impact Tool - 'Emotional Impact' Domain

    Time frame: 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.

  3. Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain

    Time frame: 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.

  4. Ostomy Leakage Impact Tool - 'Coping and in Control' Domain

    Time frame: 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.

  5. Health Related Quality of Life

    Time frame: 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.

  6. EQ-5D-5L Visual Analogue Scale (VAS)

    Time frame: Baseline (Day 0) and Final Evaluation (Week 12)

    Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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