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

September 13, 2012 updated by: Kimberly-Clark Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
293

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403
        • Heart Institute- Dept of Thoracic Surgery
  • Chile
      • Temuco, Chile
        • Hospital Dr. Hernan Henriquez 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site
Time Frame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
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
Time Frame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site
Time Frame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
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
Time Frame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
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
Time Frame: Post-surgery
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
Time Frame: Post-surgery
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
Time Frame: Before surgery (prior to skin preparation) and immediately after incision
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
Time Frame: Before surgery (prior to skin preparation) and immediately after incision
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
Time Frame: Before surgery (prior to skin preparation) and immediately after incision
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
Time Frame: Before surgery (prior to skin preparation) and immediately after incision
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
Time Frame: Immediately after surgical incision
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
Time Frame: Immediately after surgical incision
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
Time Frame: 30 days
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)
Time Frame: 30 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kimberly-Clark Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Charlotte D Owens, MD, Kimberly-Clark Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IS 100-06-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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