NCT01802606

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

October 31, 2012

Last Update Submit

February 27, 2013

Conditions

INFECTION

Keywords

surgeryadministrationinfection

Outcome Measures

Primary Outcomes (1)

  • Factors related to infection prevention after tension-free inguinal hernia repair

    up to 5 weeks

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • malignant tumor;
  • history of immune system diseases;
  • using or had used corticosteroids or immunosuppressants less than 1 month before surgery;
  • using or had used antibiotics less than 3 d before surgery;
  • pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Study Officials

  • Aidong Wen, pro.

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

March 1, 2013

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

November 1, 2011

Last Updated

March 1, 2013

Record last verified: 2013-02