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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Skin Flora Contamination
- Sponsor
- Kimberly-Clark Corporation
- Enrollment
- 293
- Locations
- 5
- Primary Endpoint
- Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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 mm
- •If HIV status is not known, the subject is not excluded.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site(Before surgery (prior to skin preparation) and after surgery (after closing fascia))
- Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site(Before surgery (prior to skin preparation) and immediately after incision)
- Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site(Before surgery (prior to skin preparation) and after surgery (after closing fascia))
- Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site(Before surgery (prior to skin preparation) and immediately after incision)
- Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site(Before surgery (prior to skin preparation) and immediately after incision)
- Post-incision Bacterial Count - Sternal Site(Immediately after surgical incision)
- Post-CABG Procedure Bacterial Count - Graft Site(Post-surgery)
- Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site(Before surgery (prior to skin preparation) and immediately after incision)
- Post-CABG Procedure Bacterial Count - Sternal Site(Post-surgery)
- Post-incision Bacterial Count - Graft Site(Immediately after surgical incision)
- Number of Patients With SSI at the Sternal Site and/or Graft Site(30 days)
- Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)(30 days)