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 range18 Years
SexALL
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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…
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)