Skin Flora ContaminationPhase 4NCT00467857

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

A Phase 4 study testing InteguSeal* skin sealant and standard surgical preparation and Standard preoperative skin preparation in people with Skin Flora Contamination, run by Kimberly-Clark Corporation at 5 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Skin Flora Contamination
What is being tested?: InteguSeal* skin sealant and standard surgical preparation and Standard preoperative skin preparation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 293 participants
Where: 5 sitesin 5 countries
Study dates: Apr 2007to Mar 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 23Show fewer

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.

Trial locations and contacts

5 sites in 5 countries.

Country

City, postcode or hospital

5 sites in 5 countries

United States1 site

Wellstar Health Systems
Marietta, Georgia, 30060

Other trials in United States

Brazil1 site

Heart Institute- Dept of Thoracic Surgery
São Paulo, São Paulo, 05403

Other trials in Brazil

Chile1 site

Hospital Dr. Hernan Henriquez Aravena
Temuco

Other trials in Chile

Germany1 site

Charité, Humboldt University- Department of Cardiovascular Surgery
Berlin, D-10117

Other trials in Germany

Singapore1 site

National Heart Centre
Singapore, S168752

Other trials in Singapore

About this 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.

Read the 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.

Conditions: Skin Flora Contamination
Being tested: InteguSeal* skin sealant and standard surgical preparation, Standard preoperative skin preparation
Keywords: cyanoacrylates, microbial sealants, skin flora contamination, surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InteguSeal* skin sealant and standard surgical preparationProcedure or surgery
Also called Kimberly Clark InteguSeal* Microbial Sealant
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.
Standard preoperative skin preparationOther
Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Study groups in NCT00467857
Study group	Role	What they receive
InteguSeal* and standard surgical preparation solutions	Active comparator	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 Receives: Procedure: InteguSeal* skin sealant and standard surgical preparation
Standard surgical skin preparation alone	Other	Prior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery Receives: Other: Standard preoperative skin preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Secondary outcomes (12)

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Mar 2009

First posted1 May 2007 (estimated)
Study startApr 2007
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Skin Flora ContaminationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467857
Sponsor's protocol ID: IS 100-06-0001
Status last verified: Jan 2011
First submitted: 27 Apr 2007
Last updated: 18 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1089/sur.2006.7.s1-13.
PubMed 16834542
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.
PubMed 16834544
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.
PubMed 16418996
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.
PubMed 10196487
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.
PubMed 12362261
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.
PubMed 21704290

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00467857
Acronym / sponsor ID: IS 100-06-0001
Conditions: Skin Flora Contamination
Keywords: cyanoacrylates, microbial sealants, skin flora contamination, surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 293 participants (actual)
Lead sponsor: Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 1 May 2007 (estimated)
Results: Posted 11 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
InteguSeal* and standard surgical preparation solutions	Active comparator	Procedure: InteguSeal* skin sealant and standard surgical preparationInteguSeal* 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
Standard surgical skin preparation alone	Other	Other: Standard preoperative skin preparationPrior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (23 listed)

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®).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InteguSeal* skin sealant and standard surgical preparationAlso: Kimberly Clark InteguSeal* Microbial SealantSurgical 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.	Procedure or surgery	InteguSeal* and standard surgical preparation solutions
Standard preoperative skin preparationSurgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.	Other	Standard surgical skin preparation alone

Primary outcome

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.
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.

12 secondary outcomes

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)
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)
Post-CABG Procedure Bacterial Count - Sternal Site
Time frame: Post-surgery
Post-CABG Procedure Bacterial Count - Graft Site
Time frame: 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
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
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
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
Post-incision Bacterial Count - Sternal Site
Time frame: Immediately after surgical incision
Post-incision Bacterial Count - Graft Site
Time frame: Immediately after surgical incision
Number of Patients With SSI at the Sternal Site and/or Graft Site
Time frame: 30 days
Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)
Time frame: 30 days

Results and safety

Results posted to the registry on 11 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
InteguSeal* and Standard Surgical Preparation Solutions	146	143
Standard Surgical Preparation Solutions	147	139

Primary outcome: 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). Mean (Standard Deviation). Unit: isolates

Measure	InteguSeal* and Standard Surgical Preparation Solutions n = 116	Standard Surgical Preparation Solutions n = 127
Value	-1.34 (1.0)	-1.31 (1.0)

InteguSeal* and Standard Surgical Preparation Solutions vs Standard Surgical Preparation Solutions: p = 0.655, Wilcoxon-Rank Sum Test

Population analysed: Per protocol

Primary outcome: 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). Mean (Standard Deviation). Unit: isolates

Measure	InteguSeal* and Standard Surgical Preparation Solutions n = 118	Standard Surgical Preparation Solutions n = 126
Value	-1.88 (1.1)	-1.75 (1.0)

InteguSeal* and Standard Surgical Preparation Solutions vs Standard Surgical Preparation Solutions: p = 0.359, Wilcoxon-Rank Sum Test

Population analysed: Per protocol

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
InteguSeal* and Standard Surgical Preparation Solutions	6 of 146 (4.1%)	6 of 146 (4.1%)	Not reported
Standard Surgical Preparation Solutions	8 of 147 (5.4%)	10 of 147 (6.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16834542Dohmen 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.
Background: PubMed 16834544Malangoni 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.
Background: PubMed 16418996Fernandez-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.
Background: PubMed 10196487Mangram 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.
Background: PubMed 12362261Mertz 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.
Derived from this study: PubMed 21704290von 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charlotte D Owens, MD study director

Kimberly-Clark Corporation

5 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Brazil, Chile, Germany, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467857, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.