Antibiotic Prophylaxis in Gynecologic Laparoscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991834

Enrollment

114

Registered

2013-11-25

Start date

2013-09-30

Completion date

2015-04-30

Last updated

2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Secondary to Surgical Procedure

Keywords

laparoscopy, surgical wound infection, antibiotic prophylaxis, gynecologic surgical procedures

Brief 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.

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.

Interventions

PROCEDUREgynecologic laparoscopy

Gynecological laparoscopy without opening hollow viscera.

DRUGCefazolin

Intravenous administration of 1 g of cefazolin

DRUGPlacebo

Intravenous administration of saline sterile solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Surgical site infection	30 days	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026