findmyKOL
Clinical trialNCT01657045UnknownPhase 1Interventional

Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy

SponsorSironRX Therapeutics, Inc.Enrollment25Median Sternotomy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Pepin Heart Institute

    Tampa, Florida, United States

    Marc Bloom, MD
    Recruiting
  • Northwestern University Bluhm Cardiovascular Inst

    Chicago, Illinois, United States

    Patrick McCarthy, MD
    Recruiting
  • Montefiore Medical Center

    New York, New York, United States

    Robert Michler, MD →
    Recruiting
  • Summa Health System Hospital

    Akron, Ohio, United States

    Eric Espinal, MD
    Recruiting
  • University of Utah Hospital

    Salt Lake City, Utah, United States

    Amit Patel, MD
    Recruiting
  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, United States

    Michael McGrath, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

JVS-100 or placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2012
Primary completion
31 Dec 2013
Completion
31 Jul 2014
Last update posted
23 Jul 2013
Registered enrollment
25
Registry id
NCT01657045
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.