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

NCT00600483 | Completed Phase 3 Results DMC

• 1 other identifier: INN-SWI-001
• Study Type: interventional
• Target: 1,502
• Locations: 1 country
• Sites: 43

Brief 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.

Conditions

Cardiac Surgery; Sternal Wound Infection

Keywords

obesity; diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90

  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.

  90 days post cardiac surgery

Secondary Outcomes (6)

• Surgically Treated Surgical Wound Infection Postoperative Day 90

  90 days post cardiac surgery

• Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee.

  90 days post cardiac surgery

• Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee.

  90 days post cardiac surgery

• Number of Participants Positive for Each Pathogen Culture

  90 days post cardiac surgery

• ASEPSIS Score

  90 days post cardiac surgery

Study Arms (2)

gentamicin Group

EXPERIMENTAL

Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy

Drug: gentamicin-collagen sponge dipped in saline

Control Group

NO INTERVENTION

Standard of care, ie, insertion of no gentamicin-collagen sponge.

Interventions

gentamicin-collagen sponge dipped in saline DRUG

100-cm2 sponge

gentamicin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innocoll: lead
• Duke University: collaborator
• Premier Research: collaborator

Study Sites (43)

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Birmingham, Alabama, United States

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Florence, Alabama, United States

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Pasadena, California, United States

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San Francisco, California, United States

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Brandon, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Augusta, Georgia, United States

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Maywood, Illinois, United States

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Springfield, Illinois, United States

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Fort Wayne, Indiana, United States

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West Des Moines, Iowa, United States

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Olathe, Kansas, United States

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Wichita, Kansas, United States

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Baltimore, Maryland, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Springfield, Massachusetts, United States

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Bay City, Michigan, United States

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Lansing, Michigan, United States

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Saginaw, Michigan, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Durham, North Carolina, 27705, United States

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Durham, North Carolina, United States

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Gastonia, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Zanesville, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Tomball, Texas, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Related Publications (1)

• 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. doi: 10.1001/jama.2010.1152.

  PMID: 20716738 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

Study Officials

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 25, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 5, 2022
• Results First Posted: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (43)