Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination - Full Text View

Sponsored by:	Kimberly-Clark Corporation
Information provided by:	Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:	NCT00467857

Purpose

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.

Condition	Intervention	Phase
Skin Flora Contamination	Device: cyanoacrylate based microbial sealant Other: Standard preoperative skin preparation	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Controlled, Parallel Group, Multi-Center, Open Label Study Comparing Common Surgical Skin Preparation Solutions in Combination With InteguSeal Versus Common Surgical Skin Preparation Solutions to Reduce Skin Flora Contamination.

Further study details as provided by Kimberly-Clark Corporation:

Primary Outcome Measures:

Qualitative reduction in skin flora at the end of surgery compared to the intact skin flora at the start of the surgery between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare quantitative reduction in microbial count of skin flora at the end of surgery to intact skin at the beginning of surgery between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparison of quantitative microbial counts at end of surgery between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparison of qualitative reduction in skin flora immediately post incision to intact skin flora at beginning of surgery between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparison of quantitative reduction in microbial count of skin flora immediately post-incision to intact skin flora at beginning of surgery between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparison of quantitative microbial count of skin flora immediately post-incision between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluation of proportion of subjects with SSIs between two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Evaluation of other factors related to SSIs. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	310
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Kimberly Clark InteguSeal* Microbial Sealant and standard prep	Device: cyanoacrylate based microbial sealant Medical device
2 Standard surgical prep	Other: Standard preoperative skin preparation Standard hospital skin preparation

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 source of pathogens for most SSIs. In addition to the known sources of SSI pathogen, there are also known risk factors for SSI. The risk factors for SSIs may be patient-related, or related to the preoperative, intra-operative, and post-operative surgical treatment and care of the patient. Many known risk factors that contribute to SSIs include, but are not limited to age, nutritional status, co-morbidities, length of pre-operative stay, duration of operation, preoperative skin prep, and surgical techniques. In addition, there are certain surgical procedures in which the risks for developing SSI are greater than other surgical procedures. While there are various pre-operative and post-operative techniques or approaches to prevent these infections in patients undergoing surgeries, such as pre-operative skin care techniques, appropriate use of antibiotic prophylaxis, and the use of other post-operative anti-microbial methods, by immobilizing the patient's endogenous skin flora, an opportunity exists to reduce the rate of skin flora contamination which leads to wound contamination.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled for an elective Coronary Artery Bypass Graft 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467857

Contacts

Contact: Shu-Ping Yang, MD

770-587-7267

shu-ping.yang@kcc.com

Locations

United States, Georgia
Wellstar Health Systems	Recruiting
Marietta, Georgia, United States, 30060
Contact: Dena Mogelnecki 770-359-7021 dena.moon@wellstar.org
Principal Investigator: William A Cooper, MD
Brazil, SP
Heart Institute- Dept of Thoracic Surgery	Recruiting
Sao Paulo, SP, Brazil, 05403
Contact: Rosangela Monteiro 55 11 3069 5372 lacrosangela@incor.usp.br
Contact: Paulo Pego Fernandes, MD 55 11 3069 5248 paulo.fernandes@incor.usp.br
Principal Investigator: Paulo Manuel Pego Fernandes, MD
Chile
Hospital Dr. Hernan Henriquez Aravena	Completed
Temuco, Chile
Germany
Charité, Humboldt University- Department of Cardiovascular Surgery	Recruiting
Berlin, Germany, D-10117
Contact: Paschal Dohmen, MD, PhD 0049 30 450 622333 pascal.dohmen@charite.de
Singapore
National Heart Centre	Recruiting
Singapore, Singapore, S168752
Contact: Florence Ang 65 64367595 Florence_Ang_sc@nhc.com.sg
Principal Investigator: LIM Chong Hee, MD

Sponsors and Collaborators

Kimberly-Clark Corporation

Investigators

Study Director:

Charlotte D Owens, MD

Kimberly-Clark Corporation

More Information

Publications:

Dohmen PM. Influence of skin flora and preventive measures on surgical site infection during cardiac surgery. Surg Infect (Larchmt). 2006;7 Suppl 1:S13-7. Review.

Malangoni MA, Cheadle WG, Dodson TF, Dohmen PM, Jones D, Katariya K, Kolvekar S, Urban JA. New opportunities for reducing risk of surgical site infection. Roundtable discussion. Surg Infect (Larchmt). 2006;7 Suppl 1:S23-39. No abstract available.

Fernandez-Ayala M, Nan DN, Farinas-Alvarez C, Revuelta JM, Gonzalez-Macias J, Farinas MC. Surgical site infection during hospitalization and after discharge in patients who have undergone cardiac surgery. Infect Control Hosp Epidemiol. 2006 Jan;27(1):85-8. Epub 2006 Jan 6.

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

Mertz PM, Davis SC, Cazzaniga AL, Drosou A, Eaglstein WH. Barrier and antibacterial properties of 2-octyl cyanoacrylate-derived wound treatment films. J Cutan Med Surg. 2003 Jan-Feb;7(1):1-6. Epub 2002 Oct 9.

Responsible Party:	Kimberly Clark Corporation ( Neil Wilcox Vice President Global Regulatory and Scientific Affairs )
Study ID Numbers:	IS 100-06-0001
Study First Received:	April 27, 2007
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00467857
Health Authority:	United States: Institutional Review Board; Brazil: National Committee of Ethics in Research; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kimberly-Clark Corporation:

cyanoacrylates
microbial sealants
skin flora contamination
surgery

ClinicalTrials.gov processed this record on January 15, 2009