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

Sponsor:	Innocoll Technologies
Collaborators:	Duke University Premier Research Group plc
Information provided by:	Innocoll Technologies
ClinicalTrials.gov Identifier:	NCT00600483

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery Sternal Wound Infection	Drug: gentamicin-collagen sponge dipped in saline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

Drug Information available for: Gentamicins

U.S. FDA Resources

Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1500
Study Start Date:	December 2007
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy	Drug: gentamicin-collagen sponge dipped in saline 100-cm2 sponge
No Intervention: 2 Standard of care, ie, insertion of no gentamicin-collagen sponge.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600483

Show 43 Study Locations

Sponsors and Collaborators

Innocoll Technologies

Duke University

Premier Research Group plc

Investigators

Study Director:

David Prior

Innocoll Technologies

More Information

No publications provided by Innocoll Technologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bennett-Guerrero E, Ferguson TB Jr, Lin M, Garg J, Mark DB, Scavo VA Jr, Kouchoukos N, Richardson JB Jr, Pridgen RL, Corey GR; SWIPE-1 Trial Group. Effect of an implantable gentamicin-collagen sponge on sternal wound infections following cardiac surgery: a randomized trial. JAMA. 2010 Aug 18;304(7):755-62.

Responsible Party:	David Prior, Innocoll Technologies
ClinicalTrials.gov Identifier:	NCT00600483 History of Changes
Other Study ID Numbers:	INN-SWI-001
Study First Received:	January 2, 2008
Last Updated:	February 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:

obesity
diabetes

Additional relevant MeSH terms:

Wound Infection
Infection
Wounds and Injuries
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012