Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrica Nilsson, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01316588
First received: March 11, 2011
Last updated: November 3, 2011
Last verified: November 2011

March 11, 2011
November 3, 2011
August 2010
October 2011   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01316588 on ClinicalTrials.gov Archive Site
Surgical site infection [ Time Frame: once ] [ Designated as safety issue: Yes ]
ASEPSIS score will be measured after 2 months
Same as current
Not Provided
Not Provided
 
Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Surgical Wound Infection
Procedure: Bare skin
Bare skin without plastic adhesive drape och microbial Sealant
  • Active Comparator: Plastic adesive drape/Microbial Sealant
    Intraoperative: Plastic adhesive drape on the chest and Microbial Sealant on the leg
    Intervention: Procedure: Bare skin
  • No Intervention: Bare skin
    Bare skin i.e. without any covering of the skin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Elective CABG and/or AVR

Exclusion Criteria:

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01316588
2010/46
Yes
Ulrica Nilsson, University Hospital Orebro
University Hospital Orebro
Not Provided
Principal Investigator: Ulrica Nilsson, PhD, Associate Professor Örebro University Hospital, Sweden
University Hospital Orebro
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP