Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT05619003
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 capacity
* Has given written consent to participate by signing the Informed Consent signature Form
* Has 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 turned
* Sacral erythema, sacral pressure marks, pre-existing sacral pressure injury
* Trauma to sacrum
* Topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment)
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05619003
Study Brief:
Protocol Section:
NCT05619003