Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

NCT ID: NCT01612052

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-10-31

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.

Detailed Description

There is an increase in surgical site infection (SSI) due to MRSA. 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. 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, the investigators are initiating a second study of patients undergoing groin plus lower extremity procedures by using combination antibiotics such as Cefazolin plus Daptomycin, Cefazolin plus Vancomycin. By decreasing post surgical site and prosthetic infections, the investigators could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates the investigators feel could also be reduced. Patients will be randomized in two groups -- Cefazolin plus Daptomycin, Cefazolin plus Vancomycin and will be evaluated during post procedure before discharge or within 30 days and between 30 and 360 days, for postoperative complications including cellulitis, graft infection, sepsis, limb loss, graft failure, and length of stay. If a patient is re-hospitalized, reason for the return and whether it is related to the procedure will be evaluated. Additionally, is there a graft failure, amputation, infection, hematoma, pseudoanurysm will be assessed. In case of a wound infection, the type of organism and finally, length of this hospitalization will be recorded.

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cefazolin plus Daptomycin

Group Type: ACTIVE_COMPARATOR

Antibiotic Prophylaxis

Intervention Type: DRUG

Comparing the antibiotic treatment related to surgery

Cefazolin plus Vancomycin

Group Type: ACTIVE_COMPARATOR

Antibiotic Prophylaxis

Intervention Type: DRUG

Comparing the antibiotic treatment related to surgery

Interventions

Antibiotic Prophylaxis

Comparing the antibiotic treatment related to surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Patrick Stone, MD

CAMC Medical Staff-with admitting privileges

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Stone, M.D.

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff-with admitting privileges

Locations

Vascular Center of Excellence

Charleston, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick Stone, M.D.

Role: CONTACT

304-388-8250 ext. 9901

Facility Contacts

Patrick Stone, M.D.

Role: primary

304-388-8250 ext. 9901

References

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:CD015022. doi: 10.1002/14651858.CD015022.pub2.

Reference Type: DERIVED

PMID: 41159585 (View on PubMed)

Other Identifiers

1997028

Identifier Type: -

Identifier Source: org_study_id