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Nano-peripheral blood extract loaded with antibiotics to treat soft tissue infection

Application of Nano-Peripheral Blood Extract Loaded with Antibiotics in Repair of Soft Tissue Infection

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080247
Enrollment
Unknown
Registered
2024-01-24
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Infection

Interventions

Control group:Commonly used clinical therapies are as follows: 1) Subjects underwent debridement to remove fibrous tissue and necrotic tissue
2) Wrap the wound with sterile gauze and change the dressing every other day. 3) Adjust the antibiotic regimen based on blood inflammation indicators.
Experimental group:Commonly used clinical therapies and Drug-loaded nano-peripheral blood extract treatment are as follows: 1) The nurse collects venous blood according to standard operating procedure

Sponsors

Department of Orthopaedic Surgery, Sir Run Run Shaw Hospital, Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient has one of the following clinical symptoms: a) local skin redness, swelling and pain; b) skin ulcers and necrosis; c) Skin temperature =38?. 2. Diagnosis of soft tissue infection with one of the following categories: a) Open full-thickness wound (such as postoperative wound cracking, healing Adverse wounds, diabetic foot ulcers, pressure injuries, traumatic wounds) combined with infection; b) Primary osteomyelitis or postoperative bone infection combined and soft tissue infection. 3. Microbiologically confirmed bacterial infection. 4. =18 years old. 5. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Life expectancy is less than 1 year. 2. Multiple organ failure. 3. Staphylococcus aureus bacteremia occurs or has occurred within one month. 4. Endocarditis occurs or has occurred within one month. 5. Infections without appropriate antibiotic treatment. 6. Presence of clinical, histological, or microbiological evidence of mycobacterial, fungal, parasitic, or viral infection. 7. Insufficient blood supply to blood vessels (ankle-brachial index ABI1.3). 8. Revascularization in the last 6 weeks. 9. Major medical conditions that impair wound healing, such as aplastic anemia, liver disease, scleroderma, and malignant tumors or immunosuppressive therapy. 10. Patients who are participating in other clinical studies. 11. The specimen collection situation is not ideal. 12. Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc. 13. Those who the researcher believes are not suitable to participate in this study for other reasons

Design outcomes

Primary

MeasureTime frame
Wound area;

Secondary

MeasureTime frame
RNA sequence;Immunofluorescence;bacteria count;Blood inflammation indicators;

Countries

China

Contacts

Public ContactLin Xianfeng

Sir Run Run Shaw Hospital, Medical College of Zhejiang University

xianfeng_lin@126.com+86 152 6884 3719

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026