Breast Neoplasms
Conditions
Keywords
Implant-based breast reconstruction, intraoperative antibiotics/antiseptics, Chinese
Brief 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.
Detailed 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.
Interventions
DRUGCefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Treatment allocation is revealed to the surgical team intraoperatively. Treatment allocation is revealed to the patient post-op in their first followup visit in the clinics.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of minor surgical site infection | assessed up to 3 months post-op | 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. |
| Occurrence of major surgical site infection | assessed up to 3 months post-op | 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. |
| Occurrence of capsular contracture | assessed from 3 months post-op up to 2 years post-op or until the trial ends, whichever comes first | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of flap necrosis | assessed up to 1 months post-op | Complete or partial flap necrosis at the surgical site by surgeon's observation; |
| Baseline and changes of patient's evaluation | 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 | Patient oriented aesthetic and overall satisfaction evaluation using Breast-Q questionnaires (implant reconstructive module) |
| Occurrence of hematoma | assessed up to 72 hours post-op | Peri-prosthetic hematoma observed by hematic drainage and reduced Hematocrit count comparing to normal range; |
| Occurrence of peri-prosthetic seroma | from 3 months post-op up to 2 years post-op or until the trial ends | Peri-prosthetic seroma observed by clinical inspection and/or breast imaging; |
Countries
China
Contacts
Primary ContactShanshan He
Backup ContactJian Yin
Outcome results
None listed