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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859375
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment
Surgical Site Infection Other: microbial skin counts in the disinfection area after paints of skin disinfectants

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.

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Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections; PAINTS Study
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 8, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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])

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.
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])




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing cardiac or abdominal (colorectal surgery, cholecystectomy) interventions at the University Hospital of Basel will be eligible for this study unless meeting exclusion criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859375


Locations
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Switzerland
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Andreas Widmer, Prof. Dr. MD University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03859375    
Other Study ID Numbers: 2018-02292; me18Widmer2
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Colony forming units
preoperative skin disinfection
microbial skin counts
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Disinfectants
Anti-Infective Agents