Suppression of surgeons skin flora during surgical procedures using a new antimicrobial surgical glove
ISRCTN | ISRCTN71391952 |
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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
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
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 |
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ojan.assadian@meduniwien.ac.at |
Study information
Study design | Phase III randomized controlled double-blind single-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Prospective, double-blind, randomized controlled single-centre trial: suppression of surgeons skin flora during surgical procedures using a new antimicrobial surgical glove |
Study objectives | 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(s) | City of Vienna Ethics Committee, 10/02/2012, ref: EK 11-201-1111 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 17/11/2011 |
Completion date | 03/02/2012 |
Eligibility
Participant type(s) | Mixed |
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Age group | Adult |
Sex | Both |
Target number of participants | 26 surgeons and a maximum of 26 patients |
Key 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 |
Key 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 |
Date of first enrolment | 17/11/2011 |
Date of final enrolment | 03/02/2012 |
Locations
Countries of recruitment
- Austria
Study participating centre
1090
Austria
Sponsor information
Industry
EMEA Headquarters
Riverside Business Park
Block J
Boulevard International 55
Brussels
B-1070
Belgium
Website | http://www.eu-ansell.com |
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Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Medical University of Vienna, MediUni Wien
- Location
- Austria
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.