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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01802606
First received: October 31, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition
INFECTION

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Department of Pharmacy, Xijing Hospital

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Factors related to infection prevention after tension-free inguinal hernia repair [ Time Frame: up to 5 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Our study aims to offer some evidence pertaining to the factors influencing the prevention of infection and complications after tension-free inguinal hernia repair.


Enrollment: 1200
Study Start Date: January 2010
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802606

Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Aidong Wen, pro. Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01802606     History of Changes
Other Study ID Numbers: 20091217
Study First Received: October 31, 2012
Last Updated: February 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
surgery
administration
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on October 01, 2014