NCT03742908

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Cefazolin/clindamycin	Local implant immersion and/or breast pocket irrigation

Timeline

• Start date: 2018-06-16
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2018-11-15
• Last updated: 2018-11-15

Locations

1 site across 1 country: China