Pressure Ulcer Prevention
Conditions
Keywords
pressure injury, Palmitoleic acid, skin care
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.
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.
Interventions
COMBINATION_PRODUCTTopical 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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model 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 . 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subepidermal Moisture (SEM) Value | 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
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes | 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. |
Countries
China
Outcome results
None listed