Evaluation of the Efficacy and Safety of Palmitoleic Acid Oil Composition in Preventing Pressure Injuries
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subepidermal Moisture (SEM) Value
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Topical POA Oil Composition Application for Pressure Injury Prevention (Combination Product)
结局指标
主要结局
Subepidermal Moisture (SEM) Value
时间窗: 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.
次要结局
- Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes(Baseline, Day 7, and Day 14.)