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A Bioadhesive Derived from Mucin of Andrias davidianus for Wound Healing

A Bioadhesive Derived from Mucin of Andrias davidianus for Wound Healing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093392
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-12-03
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Wound healing

Interventions

Test group:In this study, local skin disinfection anesthesia will be used on the inner side of the left upper arm (the groinal area). A full skin incision (up to the adipose tissue layer, with a lengt
the duration of this study was 6 months. Follow-up was continued until 2 months after the last study sampling.

Sponsors

The Affiliated Stomatological Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Subject inclusion Criteria: (1) Age: 18-50 years old; (2) Gender: either male or female; (3) Health status: Participants did not have any serious chronic or acute illness, including but not limited to heart disease, diabetes mellitus, high blood pressure, etc. Furthermore, participants should not have any mental illness or substance abuse problems. (4) Physical fitness index (BMI): BMI should be within a certain range, usually between 18.5-24.9. (5) Living habits: Participants should not be in the habit of smoking, drinking alcohol, or using illicit drugs. Consent and signed the informed consent: (6) All participants agreed to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: Subject Exclusion Criteria for: 1. Local anesthesia drug allergy; 2. Allergy constitution (allergic to more than two drugs, food, pollen); 3. Patients with severe primary diseases such as liver, kidney and hematopoietic system, or abnormal liver function, AST and ALT are 1.5 / 2 times greater than the normal value, and creatinine is greater than the upper limit of the normal value; patients with mental illness; 4. Patients with severe digestive tract diseases, such as gastrointestinal ulcer, severe vomiting, diarrhea, delayed gastric emptying, intestinal obstruction, etc. (with other factors affecting the absorption, distribution and elimination of drugs); 5. Patients with renal insufficiency (blood creatinine, urea nitrogen over 1.2 times the normal range); 6. Known major active infection, or major blood, renal, metabolic, gastrointestinal, or endocrine disorders as judged by the investigator; 7. A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 8. Women during pregnancy, lactation, or women with pregnancy intention; the subject is pregnant or breastfeeding, or planned to become pregnant or lactating during and / or within 15 weeks after completion of treatment; 9. Participants in other clinical trials in the past three months; 10.Suspected or actual drug users; current adverse habits such as alcohol and smoking (5 per day). A. Alcoholics drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol or 150 mL of alcohol); 11. In the past 10 years, there was a malignancy (except for non-melanin skin cancer, cervical cancer in situ, ductal carcinoma in situ of the breast, or stage 1 prostate cancer); 12. A history of drug abuse, drugs, or alcohol abuse; 13. Major surgery within 4 weeks prior to drug administration; 14. Tumor patients with an expected life of <6 months; 15. Patients with less than 6 weeks after the surgery of major organs, patients with poor surgical wound healing; 16. Those who have been vaccinated within 3 months before treatment; 17. Other circumstances considered unsuitable by the investigator for inclusion;

Design outcomes

Primary

MeasureTime frame
Photograph to analyze the wound closure and healing;

Secondary

MeasureTime frame
complete blood count;Urinalysis;liver function;

Countries

China

Contacts

Public ContactXimu Zhang

The Affiliated Stomatological Hospital of Chongqing Medical University

zhangximu@hospital.cqmu.edu.cn+86 132 7269 1571

Outcome results

None listed

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