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

Prospective, double-blind, randomized controlled single-centre trial: suppression of surgeons? skin flora during surgical procedures using a new antimicrobial surgical glove

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71391952
Enrollment
52
Registered
2012-05-08
Start date
2011-11-17
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of surgical site infection Infections and Infestations Infection following a procedure, not elsewhere classified

Interventions

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 an

Sponsors

Ansell Healthcare (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The differences in the bacterial skin population of surgeons? hands during surgical procedures under antimicrobial or non-antimicrobial surgical gloves

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026