Skip to main content
OpenTrials
Completed

NCT Number: NCT01316588

Recolonization Following Preoperative Disinfection 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Orebro University, Faculty of medicine and Health

Örebro, 70182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Elective CABG and/or AVR

Exclusion criteria

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

Treatment and study plan

Plastic adesive drape

Other

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

Microbial Sealant

Other

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

Primary outcomes

  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 outcomes

  1. Surgical site infection

    Time frame: once

    ASEPSIS score will be measured after 2 months

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Region Örebro County

Registry information

Official study title

Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2011
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.