Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections

NCT ID: NCT03859375

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-29

Study Completion Date

2019-10-08

Brief Summary

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This observational study investigates whether 3 paints are superior compared to 2 paints in reducing microbial skin counts in the disinfection area of cardiac and abdominal surgery patients.

Detailed Description

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Surgical site infection (SSI) remain the most common nosocomial infection in surgical departments. Preparation of the skin with disinfectants belongs to the standard of care prior to any surgical intervention but disinfection practices are heterogeneous across different hospitals and countries. Although the efficacy and effectiveness of preoperative surgical site preparation is dependent on both the antiseptic agent used and the application method, it is unclear how many paints of an antiseptic are needed to ensure adequate infection protection.

An adequately powered study including different standard antiseptic agents (i.e. chlorhexidine in alcohol (CHX) and povidone iodine in alcohol (PI)) is therefore required to compare the protective effect of different numbers of paints.

Conditions

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Surgical Site Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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2 paints of skin disinfectants

Standard microbial swabs (eSWAB) to do microbial skin counts in the disinfection area after paints of skin disinfectants will be taken by the operating room-nurses prior to skin disinfection and after paint two of a predefined area of the skin.

microbial skin counts in the disinfection area after paints of skin disinfectants

Intervention Type OTHER

microbial skin counts in the disinfection area after 2 and 3 paints of skin disinfectants (chlorhexidine in alcohol \[CHX\] and povidone iodine in alcohol \[PI\])

3 paints of skin disinfectants

Standard microbial swabs (eSWAB) to do microbial skin counts in the disinfection area after paints of skin disinfectants will be taken by the operating room-nurses prior to skin disinfection and after paint three of a predefined area of the skin.

microbial skin counts in the disinfection area after paints of skin disinfectants

Intervention Type OTHER

microbial skin counts in the disinfection area after 2 and 3 paints of skin disinfectants (chlorhexidine in alcohol \[CHX\] and povidone iodine in alcohol \[PI\])

Interventions

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microbial skin counts in the disinfection area after paints of skin disinfectants

microbial skin counts in the disinfection area after 2 and 3 paints of skin disinfectants (chlorhexidine in alcohol \[CHX\] and povidone iodine in alcohol \[PI\])

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing elective cardiac surgery at the study site
* Adult patients undergoing elective abdominal surgery at the study site
* Provision of informed consent

Exclusion Criteria

* Pregnancy reported by patient
* Emergency (non-elective) surgical interventions
* Contraindications to the use of either one of the compounds: Alcoholic CHX; Alcoholic PI
* Skin or other hypersensitivity reactions during the disinfection process
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Widmer, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-02292; me18Widmer2

Identifier Type: -

Identifier Source: org_study_id

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