Evaluation of the Efficacy and Safety of Palmitoleic Acid Oil Composition in Preventing Pressure Injuries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical POA Oil Composition Application for Pressure Injury Prevention.
- Who it may be relevant to
- Registry conditions: Pressure Ulcer Prevention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Primary outcome measures
- Subepidermal Moisture (SEM) Value [Time frame: Assessed at baseline, 7 days, and 14 days post-enrollment.]
Secondary outcome measures (1)
- Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes [Time frame: Baseline, Day 7, and Day 14.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT07547254 · CTP202512