ISRCTN - ISRCTN71391952: Suppression of surgeons skin flora during surgical procedures using a new antimicrobial surgical glove

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