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NCT Number: NCT03859375

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

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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])

Primary outcomes

  1. Change in microbial skin counts (number of Colony forming Units (CFU))

    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

    Change in microbial skin counts (CFU) after 3 paints as compared to 2 paints

Secondary outcomes

  1. 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 microbial skin counts of 0 CFU after 3 paints as compared to 2 paints

  2. 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)

    Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: PAINTS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2019
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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