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Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.
It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic disease, in which there is indication of laparoscopic surgical approach, will be consecutively select. These women will be allocated in two arms, control and study, where control group will use placebo and study will receive intravenous cephazolin. These patients will be followed for 30 days according to Centers for Disease Control and Prevention criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy. |
|
| Cefazolin | Active Comparator | Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gynecologic laparoscopy | Procedure | Gynecological laparoscopy without opening hollow viscera. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Patients are followed weekly by a masked surgeon in regard to surgical site infecton (SSI), until the 30th postoperative day. Centers for Disease Control and Prevention's (CDC) criteria and classification were adopted. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabiola SM Campos, MD | Universidade do Vale do Sapucai | Principal Investigator |
| Daniela F Veiga, MD, PhD | Universidade do Vale do Sapucai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas Samuel Libanio | Pouso Alegre | Minas Gerais | 37550-000 | Brazil | ||
| Hospital e Maternidade Santa Paula |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Cefazolin | Drug | Intravenous administration of 1 g of cefazolin |
|
|
| Placebo | Drug | Intravenous administration of saline sterile solution |
|
|
| Pouso Alegre |
| Minas Gerais |
| 37550-000 |
| Brazil |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |