Bedsores
Conditions
Brief summary
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.
Interventions
DRUGJingwanhong Ointment
A topical compound traditional Chinese medicine ointment composed of multiple herbal ingredients, applied externally to the wound surface to promote tissue repair and wound healing in patients with pressure injuries.
Sponsors
Tianjin University of Traditional Chinese Medicine
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Time (from intervention to complete epithelialization of the wound) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | 8weeks | Pain levels will be assessed and compared between the two groups of patients with pressure injuries using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, with lower scores indicating reduced pain intensity. 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. |
| Pressure Ulcer Scale for Healing (PUSH) | 8weeks | Wound healing status will be assessed and compared between the two groups using the Pressure Ulcer Scale for Healing (PUSH). The scale evaluates three dimensions-wound area, exudate amount, and tissue type-with a total score ranging from 0 to 17 points; lower scores indicate better healing. Assessments will be performed weekly from the start of treatment until the end of follow-up. |
Contacts
CONTACTTianyi Zhao M.D.
Outcome results
None listed