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

Phase 3

Completed

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

• Registration Number: ISRCTN71391952
• Lead Sponsor: Ansell Healthcare (Belgium)

Brief Summary

1. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/24116857 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-02-03
• Study Start: 2012-05-08
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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