Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00467857
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for an elective Coronary Artery Bypass Graft (CABG) surgical procedure with median sternotomy utilizing either the saphenous vein and/or radial artery as one of the graft sites within 28 days of the screening date, as documented by a Cardiothoracic Surgeon who is the Principal Investigator or sub-investigator. This includes subjects who are also receiving internal mammary artery grafts in addition to saphenous vein and/or radial artery grafts.
* The skin near or around the proposed incision sites should be intact.
Exclusion Criteria:
* Known sensitivity or allergy to cyanoacrylate, isopropyl alcohol, iodine or iodine-containing products or tape allergies.
* Female subjects that are nursing or actively lactating.
* Abnormal skin condition adjacent to or at the surgical incision sites.
* Hair removal at the surgical sites prior to entrance to the operating suite.
* Use of antimicrobial impregnated incise drapes (i.e. Ioban®).
* Hospital stay of \>14 days immediately prior to scheduled CABG surgery.
* Use of chemotherapy agents, within 30 days prior to Visit 1 screening.
* Scheduled for additional chemotherapy for the duration of the study.
* Known positive Human Immunodeficiency Virus (HIV) with a CD4 count \< 350 mm3. If HIV status is not known, the subject is not excluded.
* Currently taking antibiotics for an infection (within 30 days prior to Visit 1).
* Has had therapeutic radiation to the chest within 30 days of visit 1. This does not include subjects who receive chest xrays.
* Pre-operatively scheduled to have concomitant procedures with coronary artery bypass graft procedure.
* Scheduled to receive only one incision (a median sternotomy) without a planned saphenous vein graft and/or a radial artery graft donor site.
* Renal dialysis currently or within 30 days of visit 1.
* Morbid Obesity (Subjects with a Body Mass Index (BMI) \> 37).
* Neutropenia (absolute neutrophil count \<1000/mm3).
* Pre-operatively on an intra-aortic balloon pump or mechanical assist device.
* Has received an experimental drug or used an experimental medical device within 30 days prior to Visit 1.
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.
* Any condition, which in the opinion of the investigator would exclude the subject from the study.
* Patients on steroid use for more than 1 week within 30 days of visit 1.
* Patients on immunosuppressive therapy within 30 days of visit 1.
* Depilatory creams with containing antibiotics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00467857
Study Brief:
Protocol Section:
NCT00467857