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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pressure Ulcer Prevention
• Intervention / Treatment: Combination product: Topical POA Oil Composition Application for Pressure Injury Prevention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Impact of Topical POA Oil on Pressure Injury Outcomes and Skin Health in Hospitalized Adults; All participants receive standardized preventive care, including two-hourly repositioning, appropriate positioning support, and skin hygiene maintenance. The intervention comprised 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.

Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subepidermal Moisture (SEM) Value	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.	Assessed at baseline, 7 days, and 14 days post-enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes	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.	Baseline, Day 7, and Day 14.

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Palmitoleic acid; skin care; pressure injury
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: CTP202512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated or analysed during the current study are not publicly available due to restrictions by the ethics to protect participant privacy. Data may be available from the corresponding author upon reasonable request and with appropriate approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No