Surgical Site InfectionPhase 2NCT02569866
Antibiotics After Breast Reduction:Clinical Trial With Randomization
A Phase 2 study testing Cephalexin in people with Surgical Site Infection, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Cephalexin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to Aug 2016
- Phase
- Phase 2
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Breast hypertrophy
- Body mass index between 19 to 30 kg/m2
Who cannot join
- Patients undergoing a surgical procedure in the breast
- Diagnosis of breast pathology
- Smoking
- Childbirth or lactation less than a year
- Uncontrolled comorbidities
- Use of immunosuppressive drugs
- Misuse of capsules supplied
- Absence during the weekly follow-up
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas Samuel Libanio
Pouso Alegre, Minas Gerais, 37553079
About this study
This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.
Read the detailed description
Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.
Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.
The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.
Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.
- Conditions
- Surgical Site Infection
- Being tested
- Cephalexin, Placebo
- Keywords
- plastic surgery, mammaplasty, wound infection, prophylaxis
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CephalexinDrug
Capsules containing cephalexin/500mg
PlaceboDrug
Capsules containing placebo/500mg
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics Group | Active comparator | Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty. Receives: Drug: Cephalexin |
| Placebo Group | Placebo comparator | Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection in the postoperative of reduction mammaplasty.
After surgery, the patients will be followed for 30 days and surgical site infection rates will be observed in both groups, according to the CDC criteria.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Responsible party
- Principal investigator, Edgard da Silva Garcia, Federal University of São Paulo
- Investigators
- Lydia M Ferreira, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569866
- Sponsor's protocol ID
- ESG180402
- Status last verified
- Apr 2018
- First submitted
- 4 Oct 2015
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88.
PubMed 20585232Garcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y.
PubMed 27899130
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics After Breast Reduction:Clinical Trial With Randomization
- ClinicalTrials.gov ID
- NCT02569866
- Acronym / sponsor ID
- ESG180402
- Conditions
- Surgical Site Infection
- Keywords
- plastic surgery, mammaplasty, wound infection, prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Study start
- Nov 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Oct 2015 (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.
This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.
Detailed description
Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.
Despite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.
The breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.
Thus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics Group | Active comparator | Drug: CephalexinCapsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty. |
| Placebo Group | Placebo comparator | Drug: PlaceboCapsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Breast hypertrophy
- Body mass index between 19 to 30 kg/m2
Key exclusion criteria (8 listed)
- Patients undergoing a surgical procedure in the breast
- Diagnosis of breast pathology
- Smoking
- Childbirth or lactation less than a year
- Uncontrolled comorbidities
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 |
|---|---|---|
| CephalexinCapsules containing cephalexin/500mg | Drug | Antibiotics Group |
| PlaceboCapsules containing placebo/500mg | Drug | Placebo Group |
Primary outcome
Surgical site infection in the postoperative of reduction mammaplasty.
Time frame: 30 days postoperatively
After surgery, the patients will be followed for 30 days and surgical site infection rates will be observed in both groups, according to the CDC criteria.
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 20 Apr 2018.
- Background: PubMed 20585232Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88.
- Derived from this study: PubMed 27899130Garcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y.
Related trials for Surgical Site Infection
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Not yet recruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
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.
Lydia M Ferreira, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cephalexin in people with Surgical Site Infection, run by Federal University of São Paulo 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 2 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 20 Apr 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 the postoperative of reduction mammaplasty. (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02569866, which also lists 2 linked publications.
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 20 Apr 2018.