Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Plastic adesive drape
Microbial Sealant
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring recolonization, Plastic adhesive drape, microbial sealant, SSI, bacterial growth
Eligibility Criteria
Inclusion Criteria:
Elective CABG and/or AVR
Exclusion Criteria:
Suffer from any recent infection two weeks prior to the start of the trial
Sites / Locations
- Orebro University, Faculty of medicine and Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Plastic adesive drape
Microbial Sealant
Arm Description
Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg
Intraoperative: Microbial Sealant on the leg and bare skin on the chest
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Surgical site infection
ASEPSIS score will be measured after 2 months
Full Information
NCT ID
NCT01316588
First Posted
March 11, 2011
Last Updated
April 18, 2016
Sponsor
Örebro University, Sweden
Collaborators
Region Örebro County
1. Study Identification
Unique Protocol Identification Number
NCT01316588
Brief Title
Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
Official Title
Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
Collaborators
Region Örebro County
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
recolonization, Plastic adhesive drape, microbial sealant, SSI, bacterial growth
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plastic adesive drape
Arm Type
Experimental
Arm Description
Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg
Arm Title
Microbial Sealant
Arm Type
Experimental
Arm Description
Intraoperative: Microbial Sealant on the leg and bare skin on the chest
Intervention Type
Other
Intervention Name(s)
Plastic adesive drape
Intervention Description
Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
Intervention Type
Other
Intervention Name(s)
Microbial Sealant
Intervention Description
Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest
Primary Outcome Measure Information:
Title
Bacterial samples
Description
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.
Time Frame
Bacterial samples are taken on eight occasionson the chest and at five occations
Secondary Outcome Measure Information:
Title
Surgical site infection
Description
ASEPSIS score will be measured after 2 months
Time Frame
once
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective CABG and/or AVR
Exclusion Criteria:
Suffer from any recent infection two weeks prior to the start of the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrica Nilsson, PhD, Professor
Organizational Affiliation
Örebro University, faculty of Medicine and Health , Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orebro University, Faculty of medicine and Health
City
Örebro
ZIP/Postal Code
70182
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24907853
Citation
Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson U. Bacterial growth and wound infection following saphenous vein harvesting in cardiac surgery: a randomized controlled trial of the impact of microbial skin sealant. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1981-7. doi: 10.1007/s10096-014-2168-x. Epub 2014 Jun 8.
Results Reference
result
PubMed Identifier
24080082
Citation
Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Response to M.H. Stevens and N.M. Klinger, re: Bacterial recolonization of the skin and wound contamination during cardiac surgery. J Hosp Infect. 2013 Dec;85(4):325. doi: 10.1016/j.jhin.2013.09.001. Epub 2013 Sep 17. No abstract available.
Results Reference
result
PubMed Identifier
23623487
Citation
Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drape compared with bare skin. J Hosp Infect. 2013 Jun;84(2):151-8. doi: 10.1016/j.jhin.2013.02.011. Epub 2013 Apr 25.
Results Reference
result
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Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
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