Clinical trial NCT03859375: Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections
Official title: Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections; PAINTS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Keywords: Colony forming units
preoperative skin disinfection
microbial skin counts
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2019-03-01
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in microbial skin counts (number of Colony forming Units (CFU))
timeFrame: 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 outcomes:
measure: Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints
timeFrame: after paint two (T1, approx. after 2 minutes) and after paint three (T2; approx. after 3 minutes) before start of surgery
measure: Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints
timeFrame: after paint two (T1, approx. after 2 minutes)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Andreas Widmer, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: