Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

NCT ID: NCT01316588

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Plastic adesive drape

Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg

Group Type EXPERIMENTAL

Plastic adesive drape

Intervention Type OTHER

Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg

Microbial Sealant

Intraoperative: Microbial Sealant on the leg and bare skin on the chest

Group Type EXPERIMENTAL

Microbial Sealant

Intervention Type OTHER

Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest

Interventions

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Plastic adesive drape

Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg

Intervention Type OTHER

Microbial Sealant

Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Elective CABG and/or AVR

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Ulrica Nilsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrica Nilsson, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Örebro University, faculty of Medicine and Health , Sweden

Locations

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Orebro University, Faculty of medicine and Health

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 24907853 (View on PubMed)

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.

Reference Type RESULT
PMID: 24080082 (View on PubMed)

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.

Reference Type RESULT
PMID: 23623487 (View on PubMed)

Other Identifiers

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2010/46

Identifier Type: -

Identifier Source: org_study_id

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