Pressure Injuries - Stage 3, Pressure Injuries - Stage 4
Conditions
Keywords
Mesenchymal stem cells, Platelet rich plasma, Pressure Injuries
Brief summary
This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury.
Detailed description
The 2019 edition of the International Guidelines for Clinical Prevention and Treatment of Stress Injury states that stress injury, as a globally prevalent health issue, significantly reduces the quality of life for patients and their families, increases economic burden, and leads to significant expenditure on medical resources. In recent years, the incidence and mortality rate of pressure injuries in hospitalized patients have been increasing year by year. Therefore, there is an urgent need to find a more effective treatment method for pressure injuries in clinical practice. Human umbilical cord mesenchymal stem cells (huMSCs) have immunomodulatory and anti-inflammatory effects. Platelet rich plasma (PRP) can also secrete various nutritional factors, which can effectively promote wound healing. Therefore, the combination of the two may be a more effective treatment method for pressure injuries. At present, there are few reports on the combination of PRP and huMSCs for the treatment of pressure injury. In this study, the investigators aim to evaluate the effectiveness and safety of PRP combined with huMSCs for stage 3 and 4 pressure injuries, In order to promote their clinical application.
Interventions
BIOLOGICALPlatelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)
Inject 3mL PRP+huMSCs (5 × 106) into the edge and bottom of the wound, with 0.5 ml at each point and a distance of approximately 1-3 cm between each point. Then, apply autologous PRP gel (PRP+thrombin mixture, 2ml) evenly on the wound, with a thickness of about 2mm
OTHERControl group
Standard therapy for patients with stage 3 and 4 stress injury
Sponsors
Liaocheng People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old, regardless of gender; * Patients with stage 3 and stage 4 pressure injuries (According to National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) classification system for pressure ulcers); * There were no complications affecting the wound healing; * After through debridement for the first time, the wound volume meets the requirement of 10-100cm3; Platelet count before treatment 100\ 300×109/L; * The patient voluntarily participates and signs an informed consent form.
Exclusion criteria
* Individuals with coagulation dysfunction or hemorrhagic diseases; * People with skin diseases, diabetes and immune diseases; * Individuals with mental or psychological disorders; * Individuals with allergies to multiple drugs; * Pregnant or lactating women; * Those who need to take medication that affects platelet and coagulation function for a long time or in the near future, but have not stopped taking medication within the past week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pressure Ulcer Scale for Healing (PUSH) | Baseline,1,2,4 and 6 weeks | The scale includes three dimensions: wound area, exudate volume, and tissue type. The total score of the three dimensions was indicated the healing of pressure injury and ranged from 0 to 17 points, with 0 points indicating wound healing. The PUSH score decreased, indicating improvement. The total score increased, indicating deterioration. Multiple pressure injuries in the same patient were evaluated separately. |
| Change from baseline in Determination of growth factor content | Baseline,1, 2 and 3 weeks | Serum epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF) were detected during treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing time | up to 4 months | The wound healing standard is wound closure and epithelial tissue coverage, and the wound healing time refers to the time from the date of direct treatment to wound healing for the patient. The wound healing time was recorded through dressing change in outpatient department or phone call follow-up. |
| Positive rate of bacterial culture | Baseline and 2 weeks | The patient's wound secretions were collected for bacterial culture on the day of stem cell treatment and 2 weeks after treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | up to 1 week | Any adverse events that occur during the treatment process must be recorded in detail. The record of adverse events should include a description of the adverse event and all related symptoms, the time of occurrence, severity, duration, measures taken, and the final outcome and outcome, as well as an evaluation of the possible correlation between the adverse event and treatment. |
Countries
China
Contacts
Primary ContactChunling Yang, bachelor
Backup Contact1966-03-07
Outcome results
None listed