Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contami… (NCT00467857) | Clinical Trial Compass
CompletedPhase 4
Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
United States, Brazil, Chile293 participantsStarted 2007-04
Plain-language summary
The purpose of this study is to determine if there is a qualitative reduction in microbial skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant is used in combination with a surgical skin preparation solution.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site
Timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
2
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site
Timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)