Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

• Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90. [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  

• Proportion of patients with surgically treated surgical wound infection adjudicated by an independent blinded committee. [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: No ]
  
• Proportion of patients with deep surgical wound infections based on Centers for Disease Control criteria adjudicated by an independent blinded committee. [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: No ]
  
• Proportion of patients with superficial surgical wound infections based on Centers for Disease Control criteria adjudicated by an independent blinded committee. [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: No ]
  
• Efficacy by type of pathogen/bacteriology [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: No ]
  
• ASEPSIS score [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  
• Rehospitalization for Sternal Wound Infection [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  
• Cost analysis comparison between study groups [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: No ]
  
• Serum gentamicin levels and changes in serum creatinine level [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  
• Bone and wound healing questionnaire including Emergency Room and surgical office visits secondary to wound complaints [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  
• Pain assessments from surgery through 7 days postoperatively (see section 4.2.) and amount of pain medication administered in the first 3 days postoperatively. [ Time Frame: Through 7 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  
• Reporting of serious and nonserious AEs, including reexploration for bleeding and renal failure [ Time Frame: 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  
• All-cause mortality at 30 days, 60 days, and 90 days postop [ Time Frame: Through 90 days post cardiac surgery ] [ Designated as safety issue: Yes ]
  

Sternal wound infection (SWI) is a significant problem in cardiac surgical subjects,in particular in those with risk factors such as diabetes and obesity. There is a long unmet need for an intervention that can reduce the incidence and severity of SWIs in high-risk subjects.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When inserted into a surgical site, the collagen breaks down and the gentamicin is released at the site but very little is absorbed into the blood stream. The high levels of antibiotic at the surgical site may prevent an infection at the surgical site.

Outside of the United States more than 3,500 subjects have received treatment in clinical studies with the gentamicin-collagen sponge, primarily for orthopedic, intraabdominal, and cardiothoracic surgeries or wound infections following surgical procedures or traumatic events.

In this study, all subjects will be given treatment that is normally given to prevent surgical infections. For subjects randomly assigned to the gentamicin-collagen sponge treatment group, 2 sponges will be placed between the sternal halves during surgery. IMMEDIATELY before insertion of the sponge the surgeon should wet the sponge with saline as shown in the training/certification document. This wet sponge SHOULD BE INSERTED INTO THE STERNUM WITHIN APPROXIMATELY 15 SECONDS (AFTER THIS TIME IT MAY BECOME MORE DIFFICULT TO HANDLE). All subjects will be followed for 90 days after surgery to determine whether they develop a sternal wound infection.