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Sponsors and Collaborators: |
Innocoll Technologies Duke University Premier Research Group plc |
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Information provided by: | Innocoll Technologies |
ClinicalTrials.gov Identifier: | NCT00600483 |
The purpose of this study is to determine whether the gentamicin-collagen sponge (Collatamp G) 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 |
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Cardiac Surgery Sternal Wound Infection |
Drug: gentamicin-collagen sponge |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge (Collatamp G) in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection |
Estimated Enrollment: | 1500 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy (each 100-cm2 sponge contains 280 mg collagen and 130 mg gentamicin).
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Drug: gentamicin-collagen sponge
100-cm2 sponge contains 280 mg bovine collagen and 130 mg gentamicin
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2: No Intervention
Standard of care, ie, insertion of no gentamicin-collagen sponge.
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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. All subjects will be followed for 90 days after surgery to determine whether they develop a sternal wound infection.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | David Prior | Innocoll Technologies |
Responsible Party: | Innocoll Technologies ( David Prior ) |
Study ID Numbers: | INN-SWI-001 |
Study First Received: | January 2, 2008 |
Last Updated: | March 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00600483 History of Changes |
Health Authority: | United States: Food and Drug Administration |
obesity diabetes |
Anti-Bacterial Agents Obesity Gentamicins Wounds and Injuries |
Diabetes Mellitus Disorders of Environmental Origin Wound Infection |
Communicable Diseases Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Wounds and Injuries Disorders of Environmental Origin Enzyme Inhibitors Infection |
Pharmacologic Actions Anti-Bacterial Agents Protein Synthesis Inhibitors Therapeutic Uses Gentamicins Wound Infection |