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

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ClinicalTrials.gov Identifier: NCT03742908
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Cefazolin/clindamycin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
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.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 16, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021


Arm Intervention/treatment
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
Drug: Cefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation
Other Names:
  • Ancef
  • Kefzol
  • Cleocin

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
Drug: Cefazolin/clindamycin
Local implant immersion and/or breast pocket irrigation
Other Names:
  • Ancef
  • Kefzol
  • Cleocin




Primary Outcome Measures :
  1. Occurrence of minor surgical site infection [ Time Frame: 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.

  2. Occurrence of major surgical site infection [ Time Frame: 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.

  3. Occurrence of capsular contracture [ Time Frame: 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 Outcome Measures :
  1. Occurrence of flap necrosis [ Time Frame: assessed up to 1 months post-op ]
    Complete or partial flap necrosis at the surgical site by surgeon's observation;

  2. Occurrence of hematoma [ Time Frame: assessed up to 72 hours post-op ]
    Peri-prosthetic hematoma observed by hematic drainage and reduced Hematocrit count comparing to normal range;

  3. Occurrence of peri-prosthetic seroma [ Time Frame: 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;

  4. Baseline and changes of patient's evaluation [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients with natural breasts
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742908


Contacts
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Contact: Shanshan He +86-22-23340123 ext 1174 ssh85@yahoo.com
Contact: Jian Yin +86-22-23340123 ext 1171 yinjian@tjmuch.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Shanshan He    +86-22-23340123 ext 1174    ssh85@yahoo.com   
Principal Investigator: Jian Yin         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Principal Investigator: Jian Yin Tianjin Medical University Cancer Institute and Hospital

Publications:

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03742908     History of Changes
Other Study ID Numbers: E2018124
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Implant-based breast reconstruction
intraoperative antibiotics/antiseptics
Chinese
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents, Local
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action