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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05619003). StuddyBuddy aggregates publicly available trial information.