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

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.

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.

Study Overview

• Status: Completed
• Conditions: Skin Flora Contamination
• Intervention / Treatment: Procedure: InteguSeal* skin sealant and standard surgical preparation; Other: Standard preoperative 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.

• Study Type: Interventional
• Enrollment (Actual): 293
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403
      • Heart Institute- Dept of Thoracic Surgery
• Chile
  • Temuco, Chile
    • Hospital Dr. Hernán Henríquez Aravena
• Germany
  • Berlin, Germany, D-10117
    • Charité, Humboldt University- Department of Cardiovascular Surgery
• Singapore
  • Singapore, Singapore, S168752
    • National Heart Centre
• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: InteguSeal* and standard surgical preparation solutions; InteguSeal* microbial skin sealant was applied to surgical sites prior to incision after standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery	Procedure: InteguSeal* skin sealant and standard surgical preparation; Surgical skin preparation prior to incision using InteguSeal* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.; Other Names: Kimberly Clark InteguSeal* Microbial Sealant
Other: Standard surgical skin preparation alone; Prior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery	Other: Standard preoperative skin preparation; Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site	Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.	Before surgery (prior to skin preparation) and after surgery (after closing fascia)
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site	Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.	Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site	Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).	Before surgery (prior to skin preparation) and after surgery (after closing fascia)
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site	Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).	Before surgery (prior to skin preparation) and after surgery (after closing fascia)
Post-CABG Procedure Bacterial Count - Sternal Site	Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.	Post-surgery
Post-CABG Procedure Bacterial Count - Graft Site	Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.	Post-surgery
Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site	Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.	Before surgery (prior to skin preparation) and immediately after incision
Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site	Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.	Before surgery (prior to skin preparation) and immediately after incision
Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site	Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)	Before surgery (prior to skin preparation) and immediately after incision
Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site	Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)	Before surgery (prior to skin preparation) and immediately after incision
Post-incision Bacterial Count - Sternal Site	Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision	Immediately after surgical incision
Post-incision Bacterial Count - Graft Site	Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision	Immediately after surgical incision
Number of Patients With SSI at the Sternal Site and/or Graft Site	Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period	30 days
Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)	Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site	30 days

Collaborators and Investigators

• Sponsor: Kimberly-Clark Corporation
• Investigators: Study Director: Charlotte D Owens, MD, Kimberly-Clark Corporation

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1089/sur.2006.7.s1-13.
• 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. doi: 10.1089/sur.2006.7.s1-23. 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. doi: 10.1086/500334. Epub 2006 Jan 6.
• 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. doi: 10.1007/s10227-002-1154-6. Epub 2002 Oct 9.
• von Eckardstein AS, Lim CH, Dohmen PM, Pego-Fernandes PM, Cooper WA, Oslund SG, Kelley EL. A randomized trial of a skin sealant to reduce the risk of incision contamination in cardiac surgery. Ann Thorac Surg. 2011 Aug;92(2):632-7. doi: 10.1016/j.athoracsur.2011.03.132. Epub 2011 Jun 24.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 27, 2007
• First Submitted That Met QC Criteria: April 30, 2007
• First Posted (Estimate): May 1, 2007

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 13, 2012
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: surgery; cyanoacrylates; microbial sealants; skin flora contamination
• Other Study ID Numbers: IS 100-06-0001