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NCT05619003
Pressure Injury Prevention Post-market Clinical Follow up Study, Biatain Silicone Sacral
Conditions: Pressure Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 67
Sponsor: Coloplast A/S
Location: Denmark
Summary
A prospective single-arm study investigating the safety of Biatain Silicone Sacral while used as prophylactic prevention amongst hospital admitted patients at risk of developing a pressure injury.
Eligibility Criteria
Inclusion Criteria:Hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1≥18 years of age and has full legal capacityHas given written consent to participate by signing the Informed Consent signature FormHas a Braden score of 6-18 at screening (performed within the last 24 hours)Intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence)Exclusion Criteria:Suspected or actual spinal injury precluding the patient from being turnedSacral erythema, sacral pressure marks, pre-existing sacral pressure injuryTrauma to sacrumTopical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment)Pregnancy or breastfeeding
Source: ClinicalTrials.gov (NCT05619003). StuddyBuddy aggregates publicly available trial information.