Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes - Full Text View

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	Other: Plastic adesive drape Other: Microbial Sealant	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:

MedlinePlus related topics: Germs and Hygiene

U.S. FDA Resources

Further study details as provided by Örebro University, Sweden:

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


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
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

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 (Adult, Senior)
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Falk-Brynhildsen K, Söderquist 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.

Falk-Brynhildsen K, Söderquist 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.

Falk-Brynhildsen K, Söderquist 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.


Responsible Party:	Ulrica Nilsson, Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier:	NCT01316588 History of Changes
Other Study ID Numbers:	2010/46
Study First Received:	March 11, 2011
Last Updated:	April 18, 2016
Health Authority:	Sweden: Regional Ethical Review Board
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Örebro University, Sweden:


recolonization Plastic adhesive drape microbial sealant SSI bacterial growth

Additional relevant MeSH terms:


Wound Infection Surgical Wound Infection Infection	Wounds and Injuries Postoperative Complications Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2016