Clinical trial NCT00467857: Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Flora Contamination
Keywords: cyanoacrylates
microbial sealants
skin flora contamination
surgery
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2007-05-01
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site
timeFrame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
measure: Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site
timeFrame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
Secondary outcomes:
measure: Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site
timeFrame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
measure: Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site
timeFrame: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
measure: Post-CABG Procedure Bacterial Count - Sternal Site
timeFrame: Post-surgery
measure: Post-CABG Procedure Bacterial Count - Graft Site
timeFrame: Post-surgery
measure: Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site
timeFrame: Before surgery (prior to skin preparation) and immediately after incision
measure: Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site
timeFrame: Before surgery (prior to skin preparation) and immediately after incision
measure: Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site
timeFrame: Before surgery (prior to skin preparation) and immediately after incision
measure: Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site
timeFrame: Before surgery (prior to skin preparation) and immediately after incision
measure: Post-incision Bacterial Count - Sternal Site
timeFrame: Immediately after surgical incision
measure: Post-incision Bacterial Count - Graft Site
timeFrame: Immediately after surgical incision
measure: Number of Patients With SSI at the Sternal Site and/or Graft Site
timeFrame: 30 days
measure: Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)
timeFrame: 30 days
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Wellstar Health Systems
state: Georgia
city: Sao Paulo
country: Brazil
facility: Heart Institute- Dept of Thoracic Surgery
state: SP
city: Temuco
country: Chile
facility: Hospital Dr. Hernan Henriquez Aravena
city: Berlin
country: Germany
facility: Charité, Humboldt University- Department of Cardiovascular Surgery
city: Singapore
country: Singapore
facility: National Heart Centre
Study officials:
affiliation: Kimberly-Clark Corporation
name: Charlotte D Owens, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1089/sur.2006.7.s1-23. No abstract available.
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. doi: 10.1086/500334. Epub 2006 Jan 6.
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.
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. doi: 10.1007/s10227-002-1154-6. Epub 2002 Oct 9.
citation: 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.