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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single Center Prospective Randomized Control Trial Investigating the Short-term and Long-term Effects of Intraoperative Prophylactic Antibiotics/Antiseptics on Surgical Outcomes in Chinese Post-mastectomy Breast Reconstruction Patients

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Cefazolin/clindamycin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization is generated by one investigator that is not involved in surgery and the block size is kept hidden from other investigators and patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: saline control<br>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. | |
| Experimental: Cefazolin/clindamycin immersion<br>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 | Drug: Cefazolin/clindamycin<br>* Local implant immersion and/or breast pocket irrigation<br>* Other names: Cleocin;|
| Experimental: Cefazolin/clindamycin immersion+ IRRI<br>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 | Drug: Cefazolin/clindamycin<br>* Local implant immersion and/or breast pocket irrigation<br>* Other names: Cleocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of minor surgical site infection | the reconstructed breasts present with redness, edema, pain and rise in skin temperature by observation, drainage or wound secretion microbiology culture are positive, the symptoms are relieved by oral antibiotics. | assessed up to 3 months post-op | 
| Occurrence of major surgical site infection | the reconstructed breasts present with redness, edema, pain and rise in skin temperature by observation, drainage or wound secretion microbiology culture are positive, the symptoms are relieved by intravenous antibiotics or demand surgical interventions such as explantation or change of implant. | assessed up to 3 months post-op | 
| Occurrence of capsular contracture | Hardness, pain, and or changes of shape/volume of the reconstructed breasts both by observation or inspected by breast imaging .The grade of capsular contracture is recorded in baker's grading(I-IV). | assessed from 3 months post-op up to 2 years post-op or until the trial ends, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of flap necrosis | Complete or partial flap necrosis at the surgical site by surgeon's observation; | assessed up to 1 months post-op | 
| Occurrence of hematoma | Peri-prosthetic hematoma observed by hematic drainage and reduced Hematocrit count comparing to normal range; | assessed up to 72 hours post-op | 
| Occurrence of peri-prosthetic seroma | Peri-prosthetic seroma observed by clinical inspection and/or breast imaging; | from 3 months post-op up to 2 years post-op or until the trial ends | 
| Baseline and changes of patient's evaluation | Patient oriented aesthetic and overall satisfaction evaluation using Breast-Q questionnaires (implant reconstructive module) | evaluate at 6 months as baseline, repeated evaluation at 12 months and 24 months post-op or until the trial ends, whichever comes first, to record changes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implant-based breast reconstruction, intraoperative antibiotics/antiseptics, Chinese