ClinicalTrials.gov
ClinicalTrials.gov Menu

Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01316588
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Region Örebro County
Information provided by (Responsible Party):
Ulrica Nilsson, Örebro University, Sweden

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Other: Plastic adesive drape Other: Microbial Sealant Phase 3

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.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes
Study Start Date : August 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Plastic adesive drape
Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg
 Other: Plastic adesive drape
Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
Experimental: Microbial Sealant
Intraoperative: Microbial Sealant on the leg and bare skin on the chest
 Other: Microbial Sealant
Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bacterial samples [ Time Frame: Bacterial samples are taken on eight occasionson the chest and at five occations ]

    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 :
  1. Surgical site infection [ Time Frame: once ]
    ASEPSIS score will be measured after 2 months


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Elective CABG and/or AVR

Exclusion Criteria:

Suffer from any recent infection two weeks prior to the start of the trial

Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316588


Locations
Sweden
Orebro University, Faculty of medicine and Health
Örebro, Sweden, 70182
Sponsors and Collaborators
Örebro University, Sweden
Region Örebro County
Investigators
Principal Investigator: Ulrica Nilsson, PhD, Professor Örebro University, faculty of Medicine and Health , Sweden
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Ulrica Nilsson, Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01316588     History of Changes
Other Study ID Numbers: 2010/46
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ulrica Nilsson, Örebro University, Sweden:
recolonization
Plastic adhesive drape
microbial sealant
SSI
bacterial growth

Additional relevant MeSH terms:
Wound Infection
Surgical Wound
Surgical Wound Infection
Infection
 Wounds and Injuries
Postoperative Complications
Pathologic Processes