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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 5
- 主要终点
- Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
- •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
- •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
- •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
- •Patients on immunosuppressive therapy within 30 days of visit
- •Depilatory creams with containing antibiotics.
研究组 & 干预措施
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
干预措施: InteguSeal* skin sealant and standard surgical preparation (Procedure)
Standard surgical skin preparation alone
Prior to incision, standard surgical skin preparation in patients undergoing coronary artery bypass graft (CABG) surgery
干预措施: Standard preoperative skin preparation (Other)
结局指标
主要结局
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)(30 days)
- 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)