This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16 - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be delivered along the edge of the sternal wound using a needle-free injection device that has FDA-clearance for subcutaneous injections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Injections will be delivered depending on sternal incision length.
Injections will be delivered depending on sternal incision length.
Injections will be delivered depending on sternal incision length.
Pepin Heart Institute
Tampa, Florida, United States
RECRUITINGNorthwestern University Bluhm Cardiovascular Inst
Chicago, Illinois, United States
RECRUITINGMontefiore Medical Center
New York, New York, United States
RECRUITINGSumma Health System Hospital
Akron, Ohio, United States
RECRUITINGUniversity of Utah Hospital
Salt Lake City, Utah, United States
RECRUITINGSentara Cardiovascular Research Institute
Norfolk, Virginia, United States
RECRUITINGTo investigate the safety and tolerability of ascending doses of JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery.
Time frame: 6 months
To investigate the preliminary efficacy of ascending doses JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery.
Time frame: 6 months
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