DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: INFECTION

Intervention: Vancomycin (Drug)

Phase: Phase 2

Status: Enrolling by invitation

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
Abbas Khani-Hanjani, MD, Principal Investigator, Affiliation: University of Alberta

Summary

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

Clinical Details

Official title: Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Incidence of sternal wound infection

Secondary outcome:

Incidence of sternal wound infection

Hospitalization

Use of prophylactic antibiotics

Cost analysis for sternal wound infection treatment

Adverse events

Detailed description: During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates. The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Able to sign Informed Consent and Release of Medical Information Form

- Age ≥ 18 years

- Undergoing cardiac surgery with complete sternotomy (including re-operations)

Exclusion Criteria:

- Evidence of active infection (any culture positive or blood positive infection)

- Undergoing organ transplantation

- Patients with known hypersensitivity to vancomycin

- Pregnant or nursing women

- Mental impairment or other conditions that may not allow participant to understand

the nature, significance, and scope of study

Locations and Contacts

Additional Information

Starting date: March 2015
Last updated: March 19, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017