Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination

Completed · Phase 4

Conditions studied: Skin Flora Contamination

In brief

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.

Key facts

Study ID

NCT00467857

Run by

Kimberly-Clark Corporation

People needed

293

Starts

2007-04-01

Expected to finish

2009-03-01

Last updated by the study team

2012-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wellstar Health Systems — Marietta, Georgia, United States
• Heart Institute- Dept of Thoracic Surgery — São Paulo, São Paulo, Brazil
• Hospital Dr. Hernan Henriquez Aravena — Temuco, Chile
• Charité, Humboldt University- Department of Cardiovascular Surgery — Berlin, Germany
• National Heart Centre — Singapore, Singapore

Full record on ClinicalTrials.gov

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