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

University Hospital, Basel, Switzerland239 enrolled

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.

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

239

Conditions

Surgical Site Infection

Interventions

microbial skin counts in the disinfection area after paints of skin disinfectantsOTHER

microbial skin counts in the disinfection area after 2 and 3 paints of skin disinfectants (chlorhexidine in alcohol \[CHX\] and povidone iodine in alcohol \[PI\])

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, Switzerland

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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 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

Time frame: after paint two (T1, approx. after 2 minutes)

Data from ClinicalTrials.gov

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