NCT01316588

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

March 11, 2011

Last Update Submit

April 18, 2016

Conditions

Surgical Wound Infection

Keywords

recolonizationPlastic adhesive drapemicrobial sealantSSIbacterial growth

Outcome Measures

Primary Outcomes (1)

  • Bacterial samples

    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.

    Bacterial samples are taken on eight occasionson the chest and at five occations

Secondary Outcomes (1)

  • Surgical site infection

    once

Study Arms (2)

Plastic adesive drape

EXPERIMENTAL

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

Other: Plastic adesive drape

Microbial Sealant

EXPERIMENTAL

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

Other: Microbial Sealant

Interventions

Plastic adesive drapeOTHER

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

Plastic adesive drape
Microbial SealantOTHER

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

Microbial Sealant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CABG and/or AVR

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orebro University, Faculty of medicine and Health

Örebro, 70182, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 24907853RESULT

  • 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.

    PMID: 24080082RESULT

  • 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.

    PMID: 23623487RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrica Nilsson, PhD, Professor

    Örebro University, faculty of Medicine and Health , Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 16, 2011

Study Start

August 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 19, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)