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N/A N=22 Randomized Basic Science

An Exploratory Study Investigating Human Skin Reaction to Output

Ileostomy

Bottom Line

View on ClinicalTrials.gov: NCT02351791 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Trans Epidermal Water Loss After Test of Patches. — 45.8; 22.9; 36.8; 19.6 g/m^2/h

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Patch 1 (Other); Patch 2 (Other); Patch 3 (Other); Patch 4 (Other); Patch 5 (Other); Patch 6 (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Coloplast A/S
Primary completion
Mar 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Trans Epidermal Water Loss After Test of Patches.		 45.8; 22.9; 36.8; 19.6; 15.7; 13.3 —

Summary

The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Eligibility Criteria

Inclusion Criteria

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Have had an ileostomy for more than one year
  • Have normal to slightly red skin on the area used in the evaluation
  • Has an ileostomy with a diameter up to (≤) 35 mm
  • Have a peristomal area accessible for applied patches (assessed by investigator)

Exclusion Criteria

  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
  • Are pregnant or breastfeeding
  • Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
  • Participating in other interventional clinical investigations or have previously participated in this investigation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02351791). 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.

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