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

NCT07547254 | Enrolling By Invitation

• 1 other identifier: CTP202512
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer Prevention

Keywords

pressure injury; Palmitoleic acid; skin care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes

  Baseline, Day 7, and Day 14.

Study Arms (1)

Impact of Topical POA Oil on Pressure Injury Outcomes and Skin Health in Hospitalized Adults

EXPERIMENTAL

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

Interventions

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.

Impact of Topical POA Oil on Pressure Injury Outcomes and Skin Health in Hospitalized Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 . Participants received standard preventive care plus topical POA oil composition (1 mL to sacral area, 4 times daily for 14 days). Primary outcomes included PI incidence, Stage I reversal rate, and changes in SEM and TcPO₂. Assessments were performed at baseline, day 7, and day 14.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: April 23, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)