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

Overview

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.

Full Title of Study: “Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections; PAINTS Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 1, 2019

Detailed Description

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.

Interventions

  • Other: 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])

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in microbial skin counts (number of Colony forming Units (CFU))
    • Time Frame: prior to skin disinfection (T0) and after paint two (T1, approx. after 2 minutes) and after paint three (T2; approx. after 3 minutes) before start of surgery
    • Change in microbial skin counts (CFU) after 3 paints as compared to 2 paints

Secondary Measures

  • Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints
    • Time Frame: after paint two (T1, approx. after 2 minutes) and after paint three (T2; approx. after 3 minutes) before start of surgery
    • Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints
  • Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints
    • Time Frame: after paint two (T1, approx. after 2 minutes)
    • Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Collaborator
    • Swiss National Science Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andreas Widmer, Prof. Dr. MD, Principal Investigator, University Hospital, Basel, Switzerland

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