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Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology

NCT04635215 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 195

Last updated 2021-07-28

No results posted yet for this study

Summary

An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e. the creation of a stoma, has familiar, social and professional consequences. Personalized care, with the help of an ostomy nurse, is essential to accompany the ostomy patient in the changes of his or her life habits. In addition, the progress made in the various appliances, pouching and irrigation systems, contribute to improving the quality of life of these people.

In this context of adapted support, COLOPLAST has developed a range of ostomy pouches, the SenSura Mio BodyFit® technology range, for digestive or urinary stomas. The diversity of the devices makes it possible to find the most suitable combination to adapt to the morphology thanks to an elastic adhesive for a secure fit to individual body shape, and the textile materials used make it possible to optimize wearing comfort.

The aim of this study is to evaluate the quality of life of patients with recent ostomies with one of COLOPLAST's SenSura Mio devices at three months after discharge from the hospital. The condition of the skin around the stoma and the level of satisfaction of the patients will also be evaluated. Finally, the results obtained aim to identify factors predictive of a better quality of life in order to improve management.

Conditions

  • Ostomy

Interventions

DEVICE

Sensura Mio Bodyfit technology ostomy pouches

The use of medical devices, the ostomy pouches from Sensura Mio Bodyfit technology range, will be studied from inclusion visit (less than one month after the beginning of use) and during 3 months.

Sponsors & Collaborators

  • Laboratoires Coloplast S.A.S

    lead INDUSTRY

Principal Investigators

  • Guillaume Meurette, MD · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635215 on ClinicalTrials.gov