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

Surgical Site Infection Clinical Trial

— PAINTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859375
• Other study ID #: 2018-02292; me18Widmer2
• Status: Completed
• Start date: January 29, 2019
• Est. completion date: October 8, 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 8, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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])

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)