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

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

Condition(s) targeted: Cardiac Surgery; Sternal Wound Infection

Intervention: gentamicin-collagen sponge dipped in saline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Innocoll

Official(s) and/or principal investigator(s):
David Prior, Study Director, Affiliation: Innocoll

Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.

Clinical Details

Official title: A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

Proportion of patients with surgically treated surgical wound infection adjudicated by an independent blinded committee.

Proportion of patients with deep surgical wound infections based on Centers for Disease Control criteria adjudicated by an independent blinded committee.

Proportion of patients with superficial surgical wound infections based on Centers for Disease Control criteria adjudicated by an independent blinded committee.

Efficacy by type of pathogen/bacteriology

ASEPSIS score

Rehospitalization for Sternal Wound Infection

Cost analysis comparison between study groups

Serum gentamicin levels and changes in serum creatinine level

Bone and wound healing questionnaire including Emergency Room and surgical office visits secondary to wound complaints

Pain assessments from surgery through 7 days postoperatively (see section 4.2.) and amount of pain medication administered in the first 3 days postoperatively.

Reporting of serious and nonserious AEs, including reexploration for bleeding and renal failure

All-cause mortality at 30 days, 60 days, and 90 days postop

Detailed description: 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.

Eligibility

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

Criteria:

Inclusion Criteria:

- Scheduled to undergo nonemergent CABG and/or valve repair or replacement surgery

through a full median sternotomy. This includes the following eligible procedures: isolated CABG surgery, isolated valve surgery, and combined CABG + valve surgery.

- Be at higher risk for SWI, defined as the presence of diabetes mellitus (treated with

either oral agent or insulin) and/or obesity, defined as BMI > 30.

- Have the capacity to understand and sign an informed consent form.

- Are male or female and > 18 years of age.

- If female, be postmenopausal (no menstrual period for a minimum of 1 year), be

surgically sterilized and have a negative serum or urine pregnancy test on entry in the study, or agree to use adequate birth control during the study and for 3 months after the administration of study agent. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD).

- Agree to be available for evaluation from baseline until final evaluation at 90 days

postsurgery. Exclusion Criteria:

- Known history of hypersensitivity to gentamicin or bovine collagen.

- Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent

is obtained and the study procedures can be performed).

- Undergoing a significant concomitant surgical procedure (eg, carotid endarterectomy,

aortic root repair or replacement, DHCA, or pulmonary resection).

- Undergoing a minimally invasive or a thoracic surgical approach.

- Using a preoperative mechanical assist device or IABP if inserted for shock/low

output syndrome (an IABP is allowed if it is inserted for unstable angina).

- Active and significant systemic infection, eg active endocarditis, or a history of

significant recurrent systemic infection.

- Receiving antibiotic therapy within the 2 weeks before the date of surgery.

- Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.

- History of malignancy within the past year (except for squamous or basal cell

carcinoma of the skin that has been treated with no evidence of recurrence).

- History of major organ transplantation, including bone marrow transplantation.

- Recent history of significant drug or alcohol abuse.

- Taking systemic immunosuppressive drugs, including steroids (at a dose > 10 mg oral

prednisone daily) or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count < 200.

- Scheduled to receive "stress doses" of glucocorticoids (ie, doses > 2 mg/kg/day of

methylprednisolone or equivalent).

- Pregnant, lactating, or of childbearing potential not practicing a birth control

method with a high degree of reliability (defined in section 3. 1).

- Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.

- Refusal to accept medically indicated blood products.

- Current participation or participation within 30 days before the start of this study

in another experimental drug or device study, or is currently participating in a study during which the administration of investigational drugs within 90 days is anticipated.

- Has a moderate or severe pectus deformity.

Locations and Contacts

Birmingham, Alabama, United States

Florence, Alabama, United States

Pasadena, California, United States

San Francisco, California, United States

Brandon, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Augusta, Georgia, United States

Maywood, Illinois, United States

Springfield, Illinois, United States

Fort Wayne, Indiana, United States

West Des Moines, Iowa, United States

Olathe, Kansas, United States

Wichita, Kansas, United States

Baltimore, Maryland, United States

Salisbury, Maryland, United States

Tacoma Park, Maryland, United States

Springfield, Massachusetts, United States

Bay City, Michigan, United States

Lansing, Michigan, United States

Saginaw, Michigan, United States

St. Louis, Missouri, United States

Omaha, Nebraska, United States

New York, New York, United States

Durham, North Carolina 27705, United States

Durham, North Carolina, United States

Gastonia, North Carolina, United States

Greenville, North Carolina, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Zanesville, Ohio, United States

Portland, Oregon, United States

Allentown, Pennsylvania, United States

Bethlehem, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

Houston, Texas, United States

Tomball, Texas, United States

Richmond, Virginia, United States

Tacoma, Washington, United States

Additional Information

Starting date: December 2007
Last updated: March 22, 2012

Page last updated: August 23, 2015

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