Skin Flora Contamination Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 293 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Heart Institute- Dept of Thoracic Surgery | Sao Paulo | SP |
| Chile | Hospital Dr. Hernan Henriquez Aravena | Temuco | |
| Germany | Charité, Humboldt University- Department of Cardiovascular Surgery | Berlin | |
| Singapore | National Heart Centre | Singapore | |
| United States | Wellstar Health Systems | Marietta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Kimberly-Clark Corporation |
United States, Brazil, Chile, Germany, Singapore,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Primary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |