Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ojan Assadian
ORCID ID
Contact details
Clinical Institute for Hospital Hygiene
Medical University of Vienna
Waehringer Guertel 18-20
Building 24
Vienna
1090
Austria
+43 (0)1 40400 1904
ojan.assadian@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AMT-HAND 01/11
Study information
Scientific title
Prospective, double-blind, randomized controlled single-centre trial: suppression of surgeons skin flora during surgical procedures using a new antimicrobial surgical glove
Acronym
Study hypothesis
A 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
City of Vienna Ethics Committee, 10/02/2012, ref: EK 11-201-1111
Study design
Phase III randomized controlled double-blind single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Prevention of surgical site infection
Intervention
The 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 type
Other
Phase
Phase III
Drug names
Primary outcome measure
The 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 measures
The differences in the bacterial skin population of surgeons hands during surgical procedures under antimicrobial or non-antimicrobial surgical gloves
Overall trial start date
17/11/2011
Overall trial end date
03/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Surgeons:
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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
26 surgeons and a maximum of 26 patients
Participant exclusion criteria
Surgeons:
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
Recruitment start date
17/11/2011
Recruitment end date
03/02/2012
Locations
Countries of recruitment
Austria
Trial participating centre
Medical University of Vienna
Vienna
1090
Austria
Sponsor information
Organisation
Ansell Healthcare (Belgium)
Sponsor details
EMEA Headquarters
Riverside Business Park
Block J
Boulevard International 55
Brussels
B-1070
Belgium
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Medizinische Universität Wien
Alternative name(s)
Medical University of Vienna, MediUni Wien
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Austria
Funder name
Ansell Ltd, Richmond (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/24116857 (added 21/01/2019)