Antibiotic Prophylaxis in Gynecologic Laparoscopy

Universidade do Vale do Sapucai

Status: Completed

Conditions: Infection Secondary to Surgical Procedure

Treatments: Drug: Cefazolin; Procedure: gynecologic laparoscopy; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01991834

MPFabiola

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 114 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.

Exclusion criteria

• body mass index over 30 Kg/m2
• smoking
• diabetes type I or II with glycated hemoglobin exceeding 6.5%
• patients who are at surgical risk classification of the American Society of Anesthesiologists(ASA) as ASA III or higher
• refusal to participate
• postoperative antibiotic therapy for another indication clinical complication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.

Treatment:

Drug: Placebo

Procedure: gynecologic laparoscopy

Cefazolin

Active Comparator group

Description:

Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.

Treatment:

Procedure: gynecologic laparoscopy

Drug: Cefazolin