Evaluation of the Efficacy and Safety of Palmitoleic Acid Oil Composition in Preventing Pressure Injuries

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.

A prospective, single-center, self-controlled study was conducted enrolling adult inpatients at high risk for PIs (SEM \>0.5) or with existing Stage I PIs from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine . Participants received standard preventive care plus topical POA oil composition (1 mL to sacral area, 4 times daily for 14 days). Primary outcomes included changes in SEM and TcPO₂. Assessments were performed at baseline, day 7, and day 14.

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.