Status:
COMPLETED
Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
Lead Sponsor:
Kimberly-Clark Corporation
Conditions:
Skin Flora Contamination
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 combi...
Detailed Description
The CDC states that there are two sources of surgical site infection (SSI) pathogens- endogenous and exogenous. The endogenous flora of the patient's skin, mucous membranes, or hollow viscera are the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00467857
Start Date
April 1 2007
End Date
March 1 2009
Last Update
September 18 2012
Active Locations (5)
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1
Wellstar Health Systems
Marietta, Georgia, United States, 30060
2
Heart Institute- Dept of Thoracic Surgery
São Paulo, São Paulo, Brazil, 05403
3
Hospital Dr. Hernan Henriquez Aravena
Temuco, Chile
4
Charité, Humboldt University- Department of Cardiovascular Surgery
Berlin, Germany, D-10117