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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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])

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbial skin counts (number of Colony forming Units (CFU))	Change in microbial skin counts (CFU) after 3 paints as compared to 2 paints	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints	Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints	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 insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints	Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints	after paint two (T1, approx. after 2 minutes)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Andreas Widmer, Prof. Dr. MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2019
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 8, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Colony forming units; preoperative skin disinfection; microbial skin counts
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: 2018-02292; me18Widmer2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No