Topical POA Oil Composition Application for Pressure Injury Prevention
Topical POA Oil Composition Application for Pressure Injury Prevention: Topical application of 1 mL POA oil composition to the sacrococcygeal region four times daily (08:00, 12:00, 16:00, 20:00) for 14 consecutive days, with gentle spreading of the product without rubbing.
Study summary
To evaluate the efficacy and safety of a topical palmitoleic acid (POA) oil composition in preventing PIs and reversing Stage I damage using an integrated physiological monitoring approach.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult inpatients (aged above 18 years).
* High risk for sacral pressure injuries, objectively defined by an abnormal hydration status (Sacral Subepidermal Moisture \[SEM\] Delta \> 0.5) at screening.
Exclusion Criteria:
* Medical contraindications to standard repositioning protocols (e.g., unstable pelvic fractures).
* Use of topical medications or advanced prophylactic dressings on the sacrum within 14 days prior to enrollment.
* Active peripheral vascular disease significantly impairing local tissue perfusion.
* Documented hypersensitivity to the investigational product (POA) or its vehicle components.
Primary outcome measure(s)
Subepidermal Moisture (SEM) Value — Assessed at baseline, 7 days, and 14 days post-enrollment. Subepidermal moisture, an early biomarker for localized tissue edema and inflammation preceding visually apparent sacral pressure injuries, will be measured exclusively at the sacrum using the Provizio® SEM Scanner. The key metric is the Sacral SEM Delta, representing the maximum biocapacitance variance between the sacral bony prominence and adjacent healthy tissue. An SEM Delta exceeding 0.5 is operationalized as the threshold for abnormal subepidermal inflammation and increased localized PI risk.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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