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

NCT03859375 | Completed

• 1 other identifier: 2018-02292; me18Widmer2
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Colony forming units; preoperative skin disinfection; microbial skin counts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  after paint two (T1, approx. after 2 minutes)

Study Arms (2)

2 paints of skin disinfectants

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

3 paints of skin disinfectants

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

Interventions

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 \[PI\])

2 paints of skin disinfectants; 3 paints of skin disinfectants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adult patients undergoing elective cardiac surgery at the study site
• Adult patients undergoing elective abdominal surgery at the study site
• Provision of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Andreas Widmer, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: January 29, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 8, 2019
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

CH (1)