Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients

• Status: Unknown status
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

The study aims to investigate different approaches of local application of antibiotics/antiseptics intraoperatively in Chinese patients undergoing post-mastectomy implant based breast reconstruction, and aims to single out an intervention method that limits the use of antibiotics and maintains low rates of surgical site infection and capsular contracture. Patients who undergo post mastectomy breast reconstruction in the breast reconstruction department in Tianjin Medical University Cancer Institute and Hospital are eligible to enter the study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents, Local; Antibiotics, Antitubercular; Cefazolin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

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