Suppression of surgeons’ skin flora during surgical procedures using a new antimicrobial surgical glove

ISRCTN ISRCTN71391952
DOI https://doi.org/10.1186/ISRCTN71391952
Secondary identifying numbers AMT-HAND 01/11
Submission date
22/04/2012
Registration date
08/05/2012
Last edited
21/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
A surgical site is the incision or cut in the skin made by a surgeon to carry out a surgical procedure, and the tissue handled or manipulated during the procedure. If holes develop in the surgeon’s gloves, this can lead to skin micro-organisms contaminating the surgical site. This can lead to a surgical site infection. Sterile surgical gloves have been developed that are coated inside with the antibacterial chlorhexidine to protect healthcare workers from infection in case of glove puncture. The aim of this study is to find out whether antimicrobial gloves might reduce the risk of contamination of the surgical site in the event of a glove puncture.

Who can participate?
Surgeons and patients undergoing heart surgery

What does the study involve?
Patients are operated on following the same standard for all patients cared for at the Wilhelminen Hospital Vienna. The only difference is that surgical staff members wear one antimicrobial glove and one
standard glove on either hand. At the end of the study, the number of bacteria found on the gloves and the hands of the surgeons are compared.

What are the possible benefits and risks of participating?
There are no benefits to those taking part, but there should be benefits to future surgical patients if there are fewer bacteria on the hands wearing antimicrobial gloves, as this could help lower the number of infections after surgical procedures. The only possible risk for participants would be an allergic reaction to chlorhexidine, which would not be fatal and is extremely unlikely as the amount of chlorhexidine on the gloves is small.

Where is the study run from?
Wilhelminen Hospital Vienna (Austria)

When is the study starting and how long is it expected to run for?
November 2011 to February 2012

Who is funding the study?
1. Medical University of Vienna (Austria)
2. Ansell Ltd (Australia)

Who is the main contact?
Prof. Ojan Assadian
ojan.assadian@meduniwien.ac.at

Contact information

Prof Ojan Assadian
Scientific

Clinical Institute for Hospital Hygiene
Medical University of Vienna
Waehringer Guertel 18-20
Building 24
Vienna
1090
Austria

Phone +43 (0)1 40400 1904
Email ojan.assadian@meduniwien.ac.at

Study information

Study designPhase III randomized controlled double-blind single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleProspective, double-blind, randomized controlled single-centre trial: suppression of surgeons’ skin flora during surgical procedures using a new antimicrobial surgical glove
Study objectivesA novel sterile antimicrobial surgical glove, featuring a proprietary complex coating with 14 ingredients and chlorhexidine as active ingredient on its inner surface has been developed. It was hypothesised that this antimicrobial glove might reduce the risk of contamination of the surgical site in the event of an intraoperative breach of the integrity of the glove by suppression of re-growth of skin flora during the course of a surgical procedure.
Ethics approval(s)City of Vienna Ethics Committee, 10/02/2012, ref: EK 11-201-1111
Health condition(s) or problem(s) studiedPrevention of surgical site infection
InterventionThe main target size is the number of glove pairs, and not the number of patients. Patients will be operated on following the same standard for all patients cared for at the Department for Vascular and Endovascular Surgery of the Wilhelminen Hospital Vienna. The only difference is that 1 up to 3 surgical staff member will wear one antimicrobial and one standard non-antimicrobial sterile surgical glove on either hand. The allocation of gloves per surgeon will be randomized.
Intervention typeOther
Primary outcome measureThe number of colony forming units per mL (cfu/mL) in glove “juice” collected in real-time conditions after surgical procedures in the operating theatre (OT)
Secondary outcome measuresThe differences in the bacterial skin population of surgeons’ hands during surgical procedures under antimicrobial or non-antimicrobial surgical gloves
Overall study start date17/11/2011
Completion date03/02/2012

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants26 surgeons and a maximum of 26 patients
Key inclusion criteriaSurgeons:
1. All surgeons agreeing to participate after appropriate orientation and instruction
2. Surgeons with visibly healthy skin, without cuts or abrasions, and individuals who had not used medicated soap or medicated hand creams one week prior to the test run

Patients:
1. All patients undergoing carotid endarterectomy, aortic reconstruction for aneurysms or occlusive disease, or open surgical bypass for peripheral arterial occlusive disease, are eligible to be included into the study if no existing infection at any site is present.
2. Patients must not have a re-operation during the subsequent 30 days before the study
Key exclusion criteriaSurgeons:
1. Individuals without visibly healthy skin, with cuts or abrasions, and individuals who had used medicated soap or medicated hand creams one week prior to the test run
2. The use of alcohol-based hand rubs containing no additional compounds with a sustained antimicrobial efficacy 24 hours before testing

Patients:
1. All patients for which all other procedures are performed than carotid endarterectomy, aortic reconstruction for aneurysms or occlusive disease, or open surgical bypass for peripheral arterial occlusive disease
2. All patients with an existing infection at any site and patients having a re-operation during the subsequent 30 days
Date of first enrolment17/11/2011
Date of final enrolment03/02/2012

Locations

Countries of recruitment

  • Austria

Study participating centre

Medical University of Vienna
Vienna
1090
Austria

Sponsor information

Ansell Healthcare (Belgium)
Industry

EMEA Headquarters
Riverside Business Park
Block J
Boulevard International 55
Brussels
B-1070
Belgium

Website http://www.eu-ansell.com

Funders

Funder type

University/education

Medizinische Universität Wien
Government organisation / Local government
Alternative name(s)
Medical University of Vienna, MediUni Wien
Location
Austria
Ansell Ltd, Richmond (Australia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2014 21/01/2019 Yes No

Editorial Notes

21/01/2019: Publication reference added
16/09/2016: Plain English summary added.