Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

NCT01612052 | Unknown Phase 4

• 1 other identifier: 1997028
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at the time of vascular surgery and result in an increased hospital length of stay, increased cost of care, and an increased risk of morbidity and mortality as a consequence of surgical site infections. Thus, the investigators want to compare whether Methicillin-resistant Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI) following open arterial revascularization procedures requiring a groin plus lower extremity incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open groin plus lower extremity procedures.

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Keywords

Vascular Surgery

Outcome Measures

Primary Outcomes (1)

• Difference between number of patients with MRSA infection between two groups

  post procedure at 30 days

Secondary Outcomes (1)

• Difference between number of patients with post-op complications between two groups

  post procedure at 360 days

Study Arms (2)

Cefazolin plus Daptomycin

ACTIVE COMPARATOR

Drug: Antibiotic Prophylaxis

Cefazolin plus Vancomycin

ACTIVE COMPARATOR

Drug: Antibiotic Prophylaxis

Interventions

Antibiotic Prophylaxis DRUG

Comparing the antibiotic treatment related to surgery

Cefazolin plus Daptomycin; Cefazolin plus Vancomycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Any elective arterial revascularization procedure involving one or more groin plus lower extremity incisions
• Further, patient's considered at high risk because of history of MRSA colonization or infection, HIV, admission for \>3 months in an acute care center or long-term care center will be included in the study.

You may not qualify if:

• Patient with an allergy to Cefazolin, Daptomycin or Vancomycin.
• Patients allergic to Penicillin.
• Patients enrolled in another IRB approved biomedical study.
• Patients with active infection requiring antibiotics preoperatively.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Vascular Center of Excellence

Charleston, West Virginia, 25304, United States

RECRUITING

Related Publications (1)

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

MeSH Terms

Interventions

Antibiotic Prophylaxis

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Officials

• Patrick Stone, M.D.

  CAMC Medical Staff-with admitting privileges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Stone, M.D.

CONTACT

304-388-8250

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CAMC Medical Staff-with admitting privileges

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: June 5, 2012
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

US (1)