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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Skin Flora Contamination

Intervention / Treatment
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* Procedure: InteguSeal* skin sealant and standard surgical preparation
* Other: Standard preoperative skin preparation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: InteguSeal* and standard surgical preparation solutions<br>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<br>* 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.<br>* Other names: Kimberly Clark InteguSeal* Microbial Sealant;|
| Other: Standard surgical skin preparation alone<br>Prior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery | Other: Standard preoperative skin preparation<br>* Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyanoacrylates, microbial sealants, skin flora contamination, surgery