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Antibiotic Prophylaxis in Gynecologic Laparoscopy

Information source: Universidade do Vale do Sapucai
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection Secondary to Surgical Procedure

Intervention: gynecologic laparoscopy (Procedure); Cefazolin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Universidade do Vale do Sapucai

Official(s) and/or principal investigator(s):
Fabiola SM Campos, MD, Principal Investigator, Affiliation: Universidade do Vale do Sapucai
Daniela F Veiga, MD, PhD, Study Chair, Affiliation: Universidade do Vale do Sapucai

Summary

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.

Clinical Details

Official title: Antibiotic Prophylaxis in Gynecologic Laparoscopy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Surgical site infection

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Hospital das Clinicas Samuel Libanio, Pouso Alegre, Minas Gerais 37550-000, Brazil

Hospital e Maternidade Santa Paula, Pouso Alegre, Minas Gerais 37550-000, Brazil

Additional Information

Starting date: September 2013
Last updated: April 24, 2015

Page last updated: August 20, 2015

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