Colostomy, Ileostomy, Urostomy
Conditions
Brief summary
The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.
Interventions
DEVICEEsteem Plus with ConvaTec Moldable Technology
DEVICENatura with ConvaTec Moldable Technology
DEVICENatura Accordion with ConvaTec Moldable Technology
DEVICEEsteem synergy Plus with ConvaTec Moldable Technology
Sponsors
ConvaTec Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are 18 years old and older. * Subjects who agree to participate in the evaluation and who have signed the informed consent form. * Subjects presenting with a stoma (ileostomy, colostomy or urostomy). * Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).
Exclusion criteria
* Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem. * Subjects who are in a simultaneous clinical evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-stomal skin condition at 8-15 days following the application of the barrier. | 8-15 days | Using SACs scale to determine incidence and severity of lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier. | 1 month (± 15 days) | Using SACs scale to determine incidence and severity of lesions |
| Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier. | 2 months (± 15 days) | Using SACs scale to determine incidence and severity of lesions |
Countries
Poland
Contacts
Primary ContactKim Peters, BSc (Hons)
Backup ContactCaroline Butler, PhD
Outcome results
None listed