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Cardiac SurgeryPhase 3NCT00600483

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

A Phase 3 study testing gentamicin-collagen sponge dipped in saline in people with Cardiac Surgery and Sternal Wound Infection, run by Innocoll at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Surgery, Sternal Wound Infection
What is being tested?
gentamicin-collagen sponge dipped in saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,502 participants
Where
43 sitesUnited States
Study dates
Dec 2007to Sep 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Study site

    Akron, Ohio

  • Study site

    Allentown, Pennsylvania

  • Study site

    Augusta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Bay City, Michigan

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Brandon, Florida

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Durham, North Carolina, 27705

  • Study site

    Durham, North Carolina

  • Study site

    Florence, Alabama

  • Study site

    Fort Wayne, Indiana

  • Study site

    Gastonia, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Lansing, Michigan

  • Study site

    Maywood, Illinois

  • Study site

    Miami, Florida

  • Study site

    New York, New York

  • Study site

    Olathe, Kansas

  • Study site

    Omaha, Nebraska

  • Study site

    Pasadena, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Saginaw, Michigan

  • Study site

    Salisbury, Maryland

  • Study site

    San Francisco, California

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Massachusetts

  • Study site

    St Louis, Missouri

  • Study site

    Tacoma, Washington

  • Study site

    Takoma Park, Maryland

  • Study site

    Tomball, Texas

  • Study site

    West Des Moines, Iowa

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Zanesville, Ohio

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
gentamicin-collagen sponge dipped in saline
Keywords
obesity, diabetes
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gentamicin-collagen sponge dipped in salineDrug

    100-cm2 sponge

Study groups in NCT00600483
Study groupRoleWhat they receive
gentamicin GroupExperimentalInsertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy
Receives: Drug: gentamicin-collagen sponge dipped in saline
Control GroupNo interventionStandard of care, ie, insertion of no gentamicin-collagen sponge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days post cardiac surgery

Secondary outcomes (6)

  1. Surgically Treated Surgical Wound Infection Postoperative Day 90

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

    Measured: 90 days post cardiac surgery

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

    Measured: 90 days post cardiac surgery

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

    Measured: 90 days post cardiac surgery

  4. Number of Participants Positive for Each Pathogen Culture

    Analysis associated with Microbial Pathogens in Adjudicated 90 Day SWI Subjects ME within Per Protocol Population. Any Microbial Pathogens Detected in SWI (ME)

    Measured: 90 days post cardiac surgery

  5. ASEPSIS Score

    ASEPSIS Score through 90 days postoperative - To compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0

    Measured: 90 days post cardiac surgery

  6. Rehospitalization for Sternal Wound Infection

    Rehospitalization for Sternal Wound Infection - within 90 days postoperatively.

    Measured: 90 days post cardiac surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600483
Sponsor's protocol ID
INN-SWI-001
Status last verified
May 2022
First submitted
2 Jan 2008
Last updated
5 May 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 20716738

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gentamicin-collagen sponge dipped in saline in people with Cardiac Surgery and Sternal Wound Infection, run by Innocoll at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 (time frame: 90 days post cardiac surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00600483, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

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