Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
Nyckelord
Abstrakt
Beskrivning
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.
Datum
| Senast verifierad: | 10/31/2018 |
| Först skickat: | 11/06/2018 |
| Beräknad anmälan inlämnad: | 11/13/2018 |
| Först publicerad: | 11/14/2018 |
| Senaste uppdatering skickad: | 11/13/2018 |
| Senaste uppdatering publicerad: | 11/14/2018 |
| Faktiskt startdatum för studien: | 06/15/2018 |
| Uppskattat primärt slutdatum: | 10/30/2021 |
| Beräknat slutfört datum: | 10/30/2021 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Cefazolin/clindamycin
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| No Intervention: saline control 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 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 | |
| Experimental: Cefazolin/clindamycin immersion+ IRRI 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 |
Urvalskriterier
| Kön som är berättigade till studier | Female |
| Accepterar friska volontärer | Ja |
| Kriterier | 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 |
Resultat
Primära resultatåtgärder
1. Occurrence of minor surgical site infection [assessed up to 3 months post-op]
2. Occurrence of major surgical site infection [assessed up to 3 months post-op]
3. Occurrence of capsular contracture [assessed from 3 months post-op up to 2 years post-op or until the trial ends, whichever comes first]
Sekundära resultatåtgärder
1. Occurrence of flap necrosis [assessed up to 1 months post-op]
2. Occurrence of hematoma [assessed up to 72 hours post-op]
3. Occurrence of peri-prosthetic seroma [from 3 months post-op up to 2 years post-op or until the trial ends]
4. 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]
