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User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™

NCT02499588 — Unknown, 600 participants, ConvaTec Inc.
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Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™

RegistryNCT02499588, acronym OSMOSE
StatusUnknown
Study typeObservational
Enrollment600 (Estimated)
SponsorConvaTec Inc. (Industry)
ConditionsColostomy, Ileostomy, Urostomy
InterventionsEsteem Plus with ConvaTec Moldable Technology, Natura with ConvaTec Moldable Technology, Natura Accordion with ConvaTec Moldable Technology, Esteem synergy Plus with ConvaTec Moldable Technology (Device)
Datesstart 2015-06-01, primary completion 2016-08-01 (estimated), first posted 2015-07-16, last updated 2015-07-16
Locations1 site in Poland

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-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.

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+Arms and interventions

  • Esteem Plus with ConvaTec Moldable Technology (Device)
  • Natura with ConvaTec Moldable Technology (Device)
  • Natura Accordion with ConvaTec Moldable Technology (Device)
  • Esteem synergy Plus with ConvaTec Moldable Technology (Device)

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Voivodeship Specialistic Hospital in Gorzow Wlkp.Gorzów Wielkopolski, Lubusz VoivodeshipPolandRecruiting

+Investigators

My Notes