Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
Breast Neoplasms
About this trial
This is an interventional prevention trial for Breast Neoplasms focused on measuring Implant-based breast reconstruction, intraoperative antibiotics/antiseptics, Chinese
Eligibility Criteria
Inclusion Criteria:
- Patients who underwent mastectomy and eligible for implant-based breast reconstructions
- Karnofsky Performance Status (KPS) larger than 70
- No severe deficiency in hematological, cardiovascular system, no immunodeficiency, no severe abnormal liver or kidney function
Exclusion Criteria:
- Metastatic breast cancer
- Local or systemic infection within 30 days prior to breast reconstruction surgery
- Local, oral or systemic administration of any form of antibiotics within 30 days prior to breast reconstruction surgery
- Pre-operative complete blood count shows white blood cell (WBC) count >10*10^9/L, Neutrophil cell (N) count > 7.5*10^9/L or N%>80%
- Pre-operative blood procalcitonin (PCT) higher than upper limit of the normal range
- Past history with injection breast augmentation
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
saline control
Cefazolin/clindamycin immersion
Cefazolin/clindamycin immersion+ IRRI
Implant immersion with 100 ml sterile saline (0.9%) for 10 minutes; Breast pocket irrigation (IRRI) with 100ml type III Anerdian for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards. No antibiotics is used.
Implant immersion: implant is immersed with 200mg cefazolin in 100 ml sterile saline (0.9%) for 10 minutes, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead for immersion; Breast pocket irrigation (IRRI) with100ml type III Anerdian for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards
Implant immersion: implant is immersed with 200mg cefazolin in 100 ml sterile saline (0.9%) for 10 minutes, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead for immersion; Breast pocket irrigation (IRRI): breast pocket is irrigated with100ml type III Anerdian plus 200mg cefazolin in 100 ml sterile saline (0.9%) for 30 seconds and washed with a total of 1000ml sterile distilled water twice afterwards, if the patient is allergic to cefazolin, 600mg clindamycin in 100ml sterile saline (0.9%) is used instead of cefazolin