Factors Related to Infection Prevention After Tension-free Inguinal Hernia Repair (infection)

February 27, 2013 updated by: Xijing Hospital

Department of Pharmacy, Xijing Hospital

The investigators conducted the study in 4 teaching hospitals and 2 non-teaching hospitals of Shaanxi Province. Surgeons, clinical pharmacists and nurses took part in patient collection, information registration, protocol performance.

The investigators recruited 1200 patients with inguinal hernia undergoing inguinal hernioplasty in the six hospitals from January 2010 to July 2011. The patients were randomly allocated into control group, cefazolin group and levofloxacin group, with digital meter method , 400 in each group. The data such as age, sex, case number, length of hospital stay, antibiotic usage, post-operative infection, infection site, bacterial culture were filled in self-designed forms on computer.

Study Overview

Status

Completed

Conditions

Detailed Description

All of the patients received tension-free inguinal hernia repair with a mesh plug. The surgical-site infection (SSI) was diagnosed according to the criteria of the Centers for Disease Control and Prevention [5-6].

We chose cefazolin sodium and levofloxacin sodium chloride injection as peri-operative antibiotics. Cefazolin sodium is an effective antibiotic with a short plasma elimination half-life against gram-positive cocci (GPC) except for enterococci and meticillin-resistant staphylococci. It is recommended as one of the prior antibacterial agents used for clearing cuts and preventing infection in many countries including China. Levofloxacin sodium chloride injection has a wide anti-bacterial spectrum composed of gram-negative bacteria and gram-positive anaerobic bacteria including anaerobic bacteria. It can remain a high concentration in urine, so it is recommended as an attractive antibiotic for urinary tract operation [5].

In the control group, we gave normal saline as placebo by intravenous drip infusion for 30-60 min before operation. Cefazolin group and levofloxacin group received intravenous administration of cefazolin sodium 1000 mg and levofloxacin sodium chloride injection 200 mg, respectively, for 30-60 min before operation.

Study Type

Observational

Enrollment (Actual)

1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

e recruited 1200 patients with inguinal hernia undergoing inguinal hernioplasty in the six hospitals

Description

Inclusion Criteria:

  1. males or females aged 16-18 years old;
  2. no infection or hematological system disease before surgery;
  3. normal liver and kidney function;
  4. no pre-operative valvular heart disease;
  5. Body mass index (BMI) within 18-32.

Exclusion Criteria:

  1. fail to meet one of the inclusion criteria above;
  2. malignant tumor;
  3. history of immune system diseases;
  4. using or had used corticosteroids or immunosuppressants less than 1 month before surgery;
  5. using or had used antibiotics less than 3 d before surgery;
  6. pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Factors related to infection prevention after tension-free inguinal hernia repair
Time Frame: up to 5 weeks
up to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to offer some evidence pertaining to the factors influencing the prevention of infection and complications after tension-free inguinal hernia repair.
Time Frame: up to 6 months
Our study aims to offer some evidence pertaining to the factors influencing the prevention of infection and complications after tension-free inguinal hernia repair.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Aidong Wen, pro., Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20091217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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