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.

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Key information

Conditions

Pressure Ulcer Prevention Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical POA Oil Composition Application for Pressure Injury Prevention

Combination Product

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.

Primary outcomes

Subepidermal Moisture (SEM) Value

Time frame: 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.

Secondary outcomes

Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes

Time frame: Baseline, Day 7, and Day 14.

TcPO₂, a non-invasive indicator of local microvascular perfusion and tissue oxygenation, will be quantified using the TCM 4 monitor. The measurement will be taken at the sacrum . The outcome is reported as an absolute value in millimeters of mercury (mmHg). A TcPO₂ reading below 40 mmHg is operationalized as localized tissue hypoxia and compromised blood flow, signifying an elevated risk for pressure injury development.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 23, 2026
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed