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CompletedNCT00967941Updated Sep 14, 2026Results posted

Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

An observational study in MRSA Infections, sponsored by CAMC Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by CAMC Health System · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
169
Ages
18 Years to 90 Years
Sex
All
01

Study summary

This study prospectively selects the patients to examine the effectiveness of the investigators' current standard of prophylaxis prior to vascular surgery and to compare the effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular surgical patients.

Read the detailed description

According to Medqic.org (site for the Surgical Care Improvement Project) the current recommended drug of choice for prophylaxis prior to vascular surgery is Cefazolin (Ancef). The exception would be to allow the use of Vancomycin as an acceptable antibiotic for patients undergoing cardiac, vascular or orthopedic surgery due to the increasing risk of methicillin-resistantStaphylococcus aureus (MRSA). The significance of the study is to demonstrate that MRSA coverage is needed in vascular surgery with prosthetic graft placement in areas of the body that is at high risk for infection. By decreasing post surgical site and prosthetic infections, we could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates we feel could also be reduced. patients will be randomized in three groups such as cefazolin,vancomycin and cefazolin, daptomycin and cefazolin and then patients will be monitored per usual post-operative course (30 days and 90 days follow-up) with wound and incision evaluation. Outcome measures include hospital length of stay, the presence of a graft infection, skin infection at incision site, vascular procedure failure secondary to infection, cost, thirty day readmits, amputation, and mortality.

02

Conditions studied

  • MRSA Infections

Keywords

  • Vascular Surgery
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients 18 years of age and older undergoing a vascular surgery and or vascular access (vascular fistula or vascular graft) procedure were eligible for enrollment in the study.

Inclusion criteria

  • Patients greater than 18 years of age undergoing vascular surgery including carotid procedures and a vascular access procedure (Fistula or Graft).

Exclusion criteria

Exclusion Criteria:

  • Patients with an allergy to daptomycin or vancomycin.
  • Patients with chronic wounds.
  • Prior colonization of MRSA.
  • Increased MRSA rate facility wide.
  • Continuous inpatient stay >27 hrs prior to surgical procedure.
  • Patients with active infection requiring antibiotics preoperatively.
  • Patients with a history of MRSA colonization or infection, HIV, admission for >3 months in an acute care center or long-term care center, penicillin allergy or penicillin allergy and on dialysis.
  • Dialysis patients.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
169 participants (actual)

Groups and cohorts

  • Ancef
  • Vancomycin and Cefazolin
  • Daptomycin and Cefazolin
05

What researchers measure

Primary outcomes

  1. Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.

    Time frame: 30 days post-operative

Secondary outcomes

  1. Overall Groin Procedures in Patients With and Without Any Infection.

    Time frame: 30 days post-operative

06

Results

Posted Feb 28, 2020
Limitations and caveats
We did not have standardization of skin preparation. Additionally, we did not have a specific protocol for dressing use and time of dressing removal. We excluded high-risk patients for MRSA infection in our study.

Participant flow

recruitment was done during the period August 2007 through June 2009 at vascular center.

Participant flow — Overall Study
MilestoneAncefDaptomycin and CefazolinVancomycin and Cefazolin
Started675460
Completed625156
Not completed534

Outcome measures

PrimaryOverall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.
Time frame:
30 days post-operative
Reported as:
Number · participants
Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.
participantsAncefDaptomycin and CefazolinVancomycin and Cefazolin
Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.204
SecondaryOverall Groin Procedures in Patients With and Without Any Infection.
Time frame:
30 days post-operative
Reported as:
Number · Participants
Overall Groin Procedures in Patients With and Without Any Infection.
ParticipantsTotal Patients With InfectionPatients Without Infection
Overall Groin Procedures in Patients With and Without Any Infection.1483

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Patients———

Baseline characteristics

Age, Continuous
Age, Continuous(years)AncefDaptomycin and CefazolinVancomycin and CefazolinTotal
Mean64.37 ± 11.7866.78 ± 11.8164.36 ± 11.1265.17 ± 11.57
Sex: Female, Male
Sex: Female, Male(Participants)AncefDaptomycin and CefazolinVancomycin and CefazolinTotal
Female26202066
Male413440115
07

Study locations

1 site
  • Vascular Center of Excellence
    Charleston, West Virginia 25304, United States
08

Registry details

Key details

Study ID
NCT00967941
Lead sponsor
CAMC Health System
Responsible party
Sponsor
First posted
Aug 28, 2009
Start date
Aug 2007
Primary completion
Jun 2009
Completion
Aug 2010
Results posted
Feb 28, 2020
Last update
Sep 14, 2026

Study contacts

Patrick Stone, M.D.
principal investigator · CAMC Medical Staff-with admitting privileges

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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