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| Name | Class |
|---|---|
| Universidade do Vale do Sapucai | OTHER |
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This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cephalexin | Drug | Capsules containing cephalexin/500mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia M Ferreira, PhD | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas Samuel Libanio | Pouso Alegre | Minas Gerais | 37553079 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20585232 | Background | 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. | |
| 27899130 | Derived | Garcia 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. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002506 | Cephalexin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Placebo |
| Drug |
Capsules containing placebo/500mg |
|
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |