A Real-World Post-Marketing Re-evaluation Study of Jingwanhong Ointment for Pressure Injuries in Long-Term Bedridden Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Healing Time (from intervention to complete epithelialization of the wound)
研究概览
简要总结
The goal of this observational study is to learn whether Jingwanhong Ointment (a compound traditional Chinese medicine preparation) can effectively and safely treat pressure injuries (bedsores) in long-term bedridden patients in a real-world clinical setting. The main questions it aims to answer are:
Does treatment with Jingwanhong Ointment improve healing outcomes of pressure injuries in long-term bedridden patients? Is Jingwanhong Ointment safe for use in this patient population? Do patients with different Traditional Chinese Medicine (TCM) syndrome patterns (Qi Stagnation and Blood Stasis, Toxin Accumulation with Rotting Ulceration, and Qi-Blood Deficiency) respond differently to treatment, and which subgroups benefit most? Researchers will use propensity score matching (PSM) and Cox proportional hazards models to control for confounding factors, and will stratify patients by TCM syndrome pattern to explore treatment response and identify patient subgroups most likely to benefit from Jingwanhong Ointment.
Participants who are long-term bedridden and diagnosed with pressure injuries will be enrolled in a prospective, multicenter, real-world cohort at approximately 500 . Participants will:Receive standardized treatment with Jingwanhong Ointment as part of their routine clinical care for pressure injuries.
Be followed over time to assess wound healing outcomes, safety, and treatment response according to their TCM syndrome classification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 years
- •Expected survival ≥ 3 months
- •Long-term bedridden patients with an anticipated bed rest duration exceeding 1 month.
- •Clinically diagnosed with pressure injury (Stage I-IV), based on the diagnostic and staging criteria defined in the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline (2019), jointly developed by the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP), and the Pan Pacific Pressure Injury Alliance (PPPIA). TCM syndrome differentiation will be based on the Clinical Diagnosis and Treatment Guideline for Bedsores in Traditional Chinese Medicine Surgery, issued by the China Association of Chinese Medicine in January 2019, classifying patients into three syndrome types: Qi Stagnation and Blood Stasis, Toxin Accumulation with Putrefaction, and Qi-Blood Deficiency
- •Willing to participate in the study and provide signed informed consent
排除标准
- •Known allergy or hypersensitivity to any component of Jingwanhong Ointment
- •Diagnosed with a psychiatric disorder
- •Wound with malignant transformation or fistula formation
- •Currently participating in another clinical trial
研究组 & 干预措施
Exposed Cohort: Jingwanhong Ointment
Participants in this cohort are defined as long-term bedridden patients with pressure injuries who receive treatment with Jingwanhong Ointment.
Product specification: Jingwanhong Ointment, manufactured by Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
Dosage and administration: The wound surface is first cleansed with normal saline. An appropriate amount of Jingwanhong Ointment is then applied directly to the wound, or spread onto sterile gauze, which is placed over the wound and covered with a sterile dressing. Dressings are changed once daily.
干预措施: Jingwanhong Ointment (Drug)
Non-Exposed Cohort: Standard Care only
Participants in this cohort are defined as long-term bedridden patients with pressure injuries who do not receive treatment with Jingwanhong Ointment. These participants receive standard wound care per routine clinical practice at the study site, without the use of Jingwanhong Ointment.
结局指标
主要结局
Healing Time (from intervention to complete epithelialization of the wound)
时间窗: 8weeks
Healing time is defined as the time from initiation of wound treatment to complete epithelialization of the wound surface. This outcome is determined by visual inspection: the wound is considered epithelialized when it is completely covered by epithelial tissue with no obvious exudate or tenderness/inflammatory signs. The time from treatment initiation to complete epithelialization is recorded as the healing time. This measure reflects the speed and efficiency of wound healing. The wound will be assessed daily, and the date of first complete epithelialization will be recorded. If the wound heals completely within 4 weeks, follow-up will be terminated early and the actual healing time recorded; if not healed, observation will continue until the study endpoint at 8 weeks.
Complete Wound Healing Rate
时间窗: Weekly assessments up to the end of follow-up (8 weeks)
The original wound area is first recorded, typically by tracing the wound outline on a transparent film and calculating the area. After treatment, the remaining unhealed wound area is similarly measured using transparent film tracing and area calculation. The wound healing rate is then calculated using the formula: Wound Healing Rate = (Original Wound Area - Unhealed Wound Area) / Original Wound Area × 100%. This measure provides a direct reflection of the degree of wound healing after 4 weeks of treatment. Assessments will be performed weekly from the start of treatment until the end of follow-up.
次要结局
- Visual Analog Scale (VAS) for Pain(8weeks)
- Pressure Ulcer Scale for Healing (PUSH)(8weeks)
研究者
TIANYI ZHAO ,MD
Tianyi Zhao,M.D.
Tianjin University of Traditional Chinese Medicine