Breast NeoplasmsNCT02809729
Antibiotic Prophylaxis in Oncological Surgery of Breast
A study testing Cefazolin, sterile saline and oncologic breast surgery in people with Breast Neoplasms and Breast-Conserving Surgery, run by Fabiola Soares Moreira Campos at 1 site in Brazil.
Trial summary
Breast cancer is the most frequent malignancy in the female population Brazilian, except non-melanoma skin tumors. Surgery plays an important role in regional spot disease control and the definition of parameters for the adjuvant treatment indication. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Breast-Conserving Surgery, Wound Infection
- What is being tested?
- Cefazolin, sterile saline and oncologic breast surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients who will undergo breast surgery for cancer evil, between 20 and 75 years, without any restriction as to ethnicity, education or social class;
Who cannot join
- Patients with BMI greater than 30 kgm 2;
- Patients undergoing neoadjuvant chemotherapy;
- Patients that will undergo immediate breast reconstruction procedures;
- Patients suffering from diabetes mellitus insulin-dependent;
- Patients classified as ASA III or higher
- Patients that postoperative antibiotic therapy have indication by another
- clinical complication (cystitis, pneumonia, etc.);
- -Patients to withdraw informed consent at any stage of the study;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Do Vale Do Sapucai
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Antibiotic Prophylaxis in Oncological Surgery of Breast: Randomized Clinical Trial
Breast cancer is the most frequent malignancy in the female population Brazilian, except non-melanoma skin tumors. Surgery plays an important role in regional spot disease control and the definition of parameters for the adjuvant treatment indication. Surgical site infections (SSI) are defined as wound infections occur following invasive procedures, corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most common among patients surgical. SSIs should be examined as potential wound contamination surgical, understood as the number of micro-organisms in the body and / or tissue being operated. Considering this aspect, the cancer surgery breast are classified by their potential for contamination by clean. The use of antibiotics to prevent the SSI in mastectomies is not standardized in Handbook of National Health Surveillance Agency due to the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among services. So this randomized clinical trial to evaluate the influence of the use of Prophylactic antibiotics in SSI rates in oncological breast surgery.
Read the detailed description
KIND OF STUDY:
Primary, clinical, prospective, randomized, two-parallel-group, double-blind, controlled, interventional, analytical. SAMPLE CALCULATION: based on proportions observed in a previous study with and without antibiotic use in breast surgery (VEIGA-Filho, 2010) the number calculated patients per group was 62, with a significance level of 5% and power 80% of the test. SELECTION: will be selected in Mastology outpatient clinics 124 female patients to be undergoing breast surgery for malignancy. The selection of patients will be divided in two groups PLACEBO (N = 62): receive 0.9% saline 100 ml intravenously and CEFAZOLIN GROUP (N = 62): receive 2 g of cefazolin diluted in 0.9% saline by endovenous. In both groups will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper. Preoperatively will default collection in the region higher interquadrantes breast to be operated immediately above areolopapilar complex, which is not included in the designated area for collection. At end surgery and also in the first postoperative day, the sterile field will be positioned with fenestration on the wound. Tha material will be Standard microbiological methods used to identify microoganismos. 0.2 ml aliquots of each sample are plated on agar media hypertonic mannitol, selective for Staphylococcus sp, Sabouraud agar with chloramphenicol (0.05mg / ml), selective for fungi, agar EMB Teague, selective for enterobacteria, and agar blood, for the presence of hemolytic colonies. After 48 hours, the reading of the number of colony forming units will be held by a microbiologist. Patients are regularly monitored for the occurrence of infection, once a week for the first 30 days by a single surgeon. They will be used and the definitions of surgical site infection classifications adopted by CDC
- Being tested
- Cefazolin, sterile saline, oncologic breast surgery, Microbiology
- Medical subject headings
- Breast Neoplasms, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction
sterile salineDrug
0.9% saline sterile by endovenous, once, at the moment of anesthetic induction
oncologic breast surgeryProcedure or surgery
The patient will be submitted to a conservative oncologic breast surgery
MicrobiologyOther
Samples for quantitative cultures will be obtained in the operating room before antisepsis and the end of surgery. A sample is also collected with the same patterning, on the first postoperative day, immediately after the removal of the dressing placed in the operating room. Will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The patients will receive 0.9% saline for intravenous bottle with 100ml looks identical to the antibiotic at the start of anesthetic induction Receives: Drug: sterile saline; Procedure: oncologic breast surgery; Other: Microbiology |
| cefazolin | Active comparator | The patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start of anesthetic induction Receives: Drug: Cefazolin; Procedure: oncologic breast surgery; Other: Microbiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection in oncologic breast surgery
To evaluate the influence of antibiotic prophylaxis in surgical site infection rates
Measured: up to 30 days
Secondary outcomes (1)
cutaneous colonization in oncologic breast surgery
To evaluate the microbiota that infects the skin in oncological breast surgery
Measured: intraoperative and the first postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabiola Soares Moreira Campos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabiola Soares Moreira Campos, Universidade do Vale do Sapucai
- Investigators
- FABIOLA SM CAMPOS, MD, Study chair, department of gynecology and obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809729
- Sponsor's protocol ID
- MPRUBENS PRUDENCIO
- Status last verified
- Oct 2017
- First submitted
- 19 Jun 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Oncological Surgery of Breast: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02809729
- Acronym / sponsor ID
- MPRUBENS PRUDENCIO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Fabiola Soares Moreira CamposUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most frequent malignancy in the female population Brazilian, except non-melanoma skin tumors. Surgery plays an important role in regional spot disease control and the definition of parameters for the adjuvant treatment indication. Surgical site infections (SSI) are defined as wound infections occur following invasive procedures, corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most common among patients surgical. SSIs should be examined as potential wound contamination surgical, understood as the number of micro-organisms in the body and / or tissue being operated. Considering this aspect, the cancer surgery breast are classified by their potential for contamination by clean. The use of antibiotics to prevent the SSI in mastectomies is not standardized in Handbook of National Health Surveillance Agency due to the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among services. So this randomized clinical trial to evaluate the influence of the use of Prophylactic antibiotics in SSI rates in oncological breast surgery.
Detailed description
KIND OF STUDY:
Primary, clinical, prospective, randomized, two-parallel-group, double-blind, controlled, interventional, analytical. SAMPLE CALCULATION: based on proportions observed in a previous study with and without antibiotic use in breast surgery (VEIGA-Filho, 2010) the number calculated patients per group was 62, with a significance level of 5% and power 80% of the test. SELECTION: will be selected in Mastology outpatient clinics 124 female patients to be undergoing breast surgery for malignancy. The selection of patients will be divided in two groups PLACEBO (N = 62): receive 0.9% saline 100 ml intravenously and CEFAZOLIN GROUP (N = 62): receive 2 g of cefazolin diluted in 0.9% saline by endovenous. In both groups will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper. Preoperatively will default collection in the region higher interquadrantes breast to be operated immediately above areolopapilar complex, which is not included in the designated area for collection. At end surgery and also in the first postoperative day, the sterile field will be positioned with fenestration on the wound. Tha material will be Standard microbiological methods used to identify microoganismos. 0.2 ml aliquots of each sample are plated on agar media hypertonic mannitol, selective for Staphylococcus sp, Sabouraud agar with chloramphenicol (0.05mg / ml), selective for fungi, agar EMB Teague, selective for enterobacteria, and agar blood, for the presence of hemolytic colonies. After 48 hours, the reading of the number of colony forming units will be held by a microbiologist. Patients are regularly monitored for the occurrence of infection, once a week for the first 30 days by a single surgeon. They will be used and the definitions of surgical site infection classifications adopted by CDC
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: sterile saline, Procedure: oncologic breast surgery, Other: MicrobiologyThe patients will receive 0.9% saline for intravenous bottle with 100ml looks identical to the antibiotic at the start of anesthetic induction |
| cefazolin | Active comparator | Drug: Cefazolin, Procedure: oncologic breast surgery, Other: MicrobiologyThe patients will receive 2 g of cefazolin diluted in 0.9% saline by endovenous at the start of anesthetic induction |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients who will undergo breast surgery for cancer evil, between 20 and 75 years, without any restriction as to ethnicity, education or social class;
Key exclusion criteria (8 listed)
- Patients with BMI greater than 30 kgm 2;
- Patients undergoing neoadjuvant chemotherapy;
- Patients that will undergo immediate breast reconstruction procedures;
- Patients suffering from diabetes mellitus insulin-dependent;
- Patients classified as ASA III or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolin2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction | Drug | cefazolin |
| sterile saline0.9% saline sterile by endovenous, once, at the moment of anesthetic induction | Drug | placebo |
| oncologic breast surgeryThe patient will be submitted to a conservative oncologic breast surgery | Procedure or surgery | cefazolin, placebo |
| MicrobiologySamples for quantitative cultures will be obtained in the operating room before antisepsis and the end of surgery. A sample is also collected with the same patterning, on the first postoperative day, immediately after the removal of the dressing placed in the operating room. Will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper. | Other | cefazolin, placebo |
Primary outcome
surgical site infection in oncologic breast surgery
Time frame: up to 30 days
To evaluate the influence of antibiotic prophylaxis in surgical site infection rates
1 secondary outcome
cutaneous colonization in oncologic breast surgery
Time frame: intraoperative and the first postoperative day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FABIOLA SM CAMPOS, MD study chair
department of gynecology and obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin, sterile saline and oncologic breast surgery in people with Breast Neoplasms and Breast-Conserving Surgery, run by Fabiola Soares Moreira Campos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection in oncologic breast surgery (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.