N/A N=37 Randomized Treatment

Investigation of the Performance of Ostomy Base Plate

Ileostomy - Stoma

Bottom Line

View on ClinicalTrials.gov: NCT01103466 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Apr 2013

Primary outcome: Primary: Leakage Under the Base Plate — 8.2; 5.5; 8.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Atlas (Device); SenSura (Device); Conform 2 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Leakage Under the Base Plate	8.2; 5.5; 8.0	—

Summary

The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.

Eligibility Criteria

Inclusion Criteria

Have given written Informed Consent
Are at least 18 years old
Had their ileostomy for minimum 3 months with a size between 20-40 mm
Have mental capacity to understand study guidelines and questionnaires
Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
Experience leakage under the base plate at least one a week
Are currently using a flat 2-piece base plate with mechanical coupling
Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study

Exclusion Criteria

Pregnant or breast-feeding
Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
Currently receiving or have within the past 2 months received radio- and/or chemotherapy
Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
Currently using a convex system
Participating in other clinical studies or have previously participated in this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01103466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.