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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2025 | Apr 19, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2025 | Dec 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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| Baseline, Day 7, and Day 14. |