A prospective, multi-center, stratified randomization, single blind, parallel, pivotal comparative clinical trial study to assess wound healing effect and safety of MTHG0808 and Collatamp®G apply to Total Mastectomy with sentinel lymph node biopsy or axillary lymph nodes dissection.

Meditip0 个研究点目标入组 200 人开始时间: 待定最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•1) Female patients aged 19 to 70 years old.
•2) A person who are diagnosed with breast cancer and scheduled to undergo mastectomy with sentinel lymph node biopsy or axillary lymph nodes dissection.
•3) A person who fall under ASA Class I and II according to the body grade classification of the American Society of Anesthesia.
•4) A person who voluntarily agrees to participate in this clinical trial.

•1) A person who overreacts to protein or gentamicin
•2) Liver function (ALT or AST at screening is more than three times the normal upper limit), creatine >2.0 mg/dL at renal function screening), and blood coagulation abnormalities
•3) Diabetes factors that are not controlled by drugs (glucose 126 mg/dL or more of fasting blood sugar)
•4) Patients with immunosuppressed or those with autoimmune diseases.
•5) A person who is diagnosed inflammatory breast cancer.
•6) A person who is expected to have a problem with the healing process of the surgical site.
•7) A person who is planning a neoadjuvant radiotherapy.
•8) The researcher judged that anesthesia or reoperation was inappropriate due to an internal medical disease.
•9) Pregnant or lactating patients or childbearing patients who are not willing to use appropriate contraception.
•10) A person with a history of malignant tumors including leukemia and lymphoma within the past 5 years.
•11) Patients with serious diseases (e.g., heart failure, kidney failure, pancreatitis, etc.) determined by the tester that it could affect the test.
•12) A person who has been administered other clinical drugs or medical devices for clinical trials within 4 weeks before screening.
•13) Those who are deemed inappropriate to participate in this clinical trial according to the judgment of researchers.

发起方

Meditip