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

Study Overview
=================
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.

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

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Other: microbial skin counts in the disinfection area after paints of skin disinfectants


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2 paints of skin disinfectants<br>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<br>* 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])<br>|
| 3 paints of skin disinfectants<br>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<br>* 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])<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colony forming units, preoperative skin disinfection, microbial skin counts