CompletedNot Applicable

Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)

Denmark5 participantsStarted 2016-12

Plain-language summary

This study investigates the impact real output has on peristomal skin covered by an adhesive

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 intact skin on the area used in the evaluation
✓. Has an ileostomy with a diameter up to (≤) 35 mm
✓. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

✕. Currently receiving or have within the past 2 month 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 investigating scientist)
✕. Participating in other interventional clinical investigations or have previously participated in this evaluation

Trans epidermal water loss

Timeframe: 4 - 24 hours

NCT IDNCT02992444

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12