Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruct… (NCT03742908) | Clinical Trial Compass
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Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
China291 participantsStarted 2018-06-16
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of minor surgical site infection
Timeframe: assessed up to 3 months post-op
2
Occurrence of major surgical site infection
Timeframe: assessed up to 3 months post-op
3
Occurrence of capsular contracture
Timeframe: assessed from 3 months post-op up to 2 years post-op or until the trial ends, whichever comes first
Trial details
NCT IDNCT03742908
SponsorTianjin Medical University Cancer Institute and Hospital