Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

Study Overview
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Brief Summary
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The purpose of this study is to measure the time to recolonization intraoperatively after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape on the chest as well as with or without microbial sealant on the leg.

Detailed Description
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The purpose of this study is to measure the time to recolonization intraoperative after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape as well as with or without microbial sealant on the leg. A RCT study of 140 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) are included. The investigators test the hypothesis that patients randomized to no plastic adhesive drape intraoperatively will have a reduced recolonisation compared to patients with plastic adhesive drape.

Official Title
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Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Other: Plastic adesive drape
* Other: Microbial Sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective CABG and/or AVR Exclusion Criteria: Suffer from any recent infection two weeks prior to the start of the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plastic adesive drape<br>Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg | Other: Plastic adesive drape<br>* Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg<br>|
| Experimental: Microbial Sealant<br>Intraoperative: Microbial Sealant on the leg and bare skin on the chest | Other: Microbial Sealant<br>* Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial samples | Bacterial samples on the skin of the chest: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter five times both on the skin and in the surgical wound i.e. 60, 120, 180 and 240 minutes intraoperatively as well as at the closure of the surgical wound. Bacterial samples on the leg: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter at two occasions both : on the skin and in the surgical wound i.e. at the incision and at the closure of the surgical wound. | Bacterial samples are taken on eight occasionson the chest and at five occations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | ASEPSIS score will be measured after 2 months | once | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recolonization, Plastic adhesive drape, microbial sealant, SSI, bacterial growth