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

Tianjin Medical University

Status: Unknown

Conditions: Breast Neoplasms

Treatments: Drug: Cefazolin/clindamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03742908

E2018124

Details and patient eligibility

About

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.

Full description

There is an ongoing trend towards implant based breast reconstruction in post-mastectomy patients in China. In 2015, more than 60% of patients undergoing breast reconstruction in Tianjin Medical University Cancer Institute and Hospital opted for implant based breast reconstruction. One of the major complications in implant based breast reconstruction is infection, which could cause implant explantation, delay the time to adjuvant therapies in breast cancer patients, and inflict adverse psychological effects. Although empirical intravenous and/or oral antibiotics are suggested peri-operatively, local applications of antibiotics/antiseptics and their combinations are applied differently in many medical centers worldwide, and some even suggest against the use of intraoperative local antibiotics. Furthermore, there is no consensus as to the local application of antibiotics intraoperatively for breast reconstruction patients in Chinese population. We therefore designed an open-label prospective randomized control trial in our Chinese patient population to investigate the effects of three different approaches of intraoperative surgical site intervention with antibiotics and or antiseptics. In each groups, all peri-operative interventions are standardized to best reduce bias. Short-term infection rate and long-term capsular contracture rate will be observed in the hope of singling out the best modality in our medical center to integrate into the overall comprehensive treatment for female breast cancer patients.

Enrollment: 291 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 3 patient groups

saline control

No Intervention group

Description:

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.

Cefazolin/clindamycin immersion

Experimental group

Description:

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

Treatment:

Drug: Cefazolin/clindamycin

Cefazolin/clindamycin immersion+ IRRI

Experimental group

Description:

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

Treatment:

Drug: Cefazolin/clindamycin