Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes|
- Bacterial samples [ Time Frame: Bacterial samples are taken on eight occasionson the chest and at five occations ] [ Designated as safety issue: Yes ]
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.
- Surgical site infection [ Time Frame: once ] [ Designated as safety issue: Yes ]ASEPSIS score will be measured after 2 months
|Study Start Date:||August 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Plastic adesive drape/Microbial Sealant
Intraoperative: Plastic adhesive drape on the chest and Microbial Sealant on the leg
Procedure: Bare skin
Bare skin without plastic adhesive drape och microbial Sealant
No Intervention: Bare skin
Bare skin i.e. without any covering of the skin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316588
|Örebro University Hospital|
|Örebro, Sweden, 70185|
|Principal Investigator:||Ulrica Nilsson, PhD, Associate Professor||Örebro University Hospital, Sweden|