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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
History of Changes
  Purpose

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 Intervention Phase
Surgical Wound Infection
 Procedure: Bare skin
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • Surgical site infection [ Time Frame: once ] [ Designated as safety issue: Yes ]
    ASEPSIS score will be measured after 2 months


Estimated Enrollment: 140
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316588

Locations
Sweden
Örebro University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Ulrica Nilsson, PhD, Associate Professor Örebro University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Ulrica Nilsson, Department of Nursing Umeå university and Centre for Health Care Sciences, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01316588     History of Changes
Other Study ID Numbers: 2010/46
Study First Received: March 11, 2011
Last Updated: November 3, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:
recolonization
Plastic adhesive drape
microbial sealant
SSI
bacterial growth

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

ClinicalTrials.gov processed this record on June 18, 2013