None listed
Conditions
Interventions
Procedure/Surgery : In the test group, SC Fill Paste, a breast reconstruction implant, is applied during surgery to fill and suture the defect area where the breast cancer was removed.
In the control
Sponsors
Soon Chun Hyang University Hospital Seoul
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women over 19 years of age and under 80 years of age 2) Those scheduled for breast conservation surgery due to breast cancer 3) A person who has heard a sufficient explanation of the purpose and content of this clinical trial, the characteristics of human tissue for clinical trial, etc., has voluntarily decided to participate in the clinical trial, and the person (or agent) has provided written consent in the consent form.
Exclusion criteria
Exclusion criteria: 1) Those with unstable medical conditions and clinically significant diseases that may affect the evaluation of the efficacy and safety of the clinical trial by the investigator 2) Those with bilateral or multicentric breast cancer 3) Those with metastatic breast cancer or those whose cancer has recurred before surgery 4) Those with underlying diseases such as infectious diseases, autoimmune diseases (e.g., rheumatic diseases, etc.), and blood coagulation disorders 5) Those with a history of drug or alcohol use disorder 6) Those with a history of hypersensitivity to the antibiotics Amphotericin B, Polymyxin B, and Vancomycin 7) Those with a BMI = 35 kg/m2 8) Current smokers 9) Uncontrolled diabetics 10) Those with a history of prior chemotherapy or radiation therapy to the breast reconstruction site prior to breast reconstruction 11) Those taking immunosuppressants due to organ transplantation 12) Those currently undergoing chemotherapy for cancer other than breast cancer 13) Pregnant and lactating women 14) Those who plan to become pregnant during this clinical trial or are medically permitted to become pregnant Women of childbearing potential who will not use contraception * Women of childbearing potential: Women who have experienced menarche and are not successfully surgically sterilized (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or menopausal (amenorrhea for 12 months or more since the last menstrual period without other reasons) * Medically acceptable contraceptive methods: Hormonal contraceptives (oral contraceptives used for at least 3 months, injectable or implantable contraceptives), intrauterine devices (IUDs (Intrauterine Devices), IUSs (Intrauterine Systems)), vasectomy, tubal ligation, double barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), and single barrier methods combined with spermicide 15) Those who have participated in another clinical trial within 4 weeks of Visit 1 * However, participation in other clinical trials is based on the last application date of the investigational drug/medical device. 16) Those who are deemed unsuitable for participation in this clinical trial based on the medical opinion of other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in the difference in distance from the sternal notch to the nipples on both sides (cm) | — |
Secondary
| Measure | Time frame |
|---|---|
| Variation in the difference in distance from the sternal notch to the nipples on both sides (cm);Change in the difference in nipple height between the two sides (cm);Change in the difference in distance (cm) from the mid-sternal line to the nipples on both sides; Change in SC Fill Paste(mm);Body Image Scale score | — |
Countries
Korea, Republic of
Contacts
Public ContactJun-Hee Lee
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed