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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03859375
Acronym
PAINTS
Enrollment
239
Registered
2019-03-01
Start date
2019-01-29
Completion date
2019-10-08
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

Colony forming units, preoperative skin disinfection, microbial skin counts

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.

Interventions

OTHERmicrobial 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 \[PI\])

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in microbial skin counts (number of Colony forming Units (CFU))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 surgeryChange in microbial skin counts (CFU) after 3 paints as compared to 2 paints

Secondary

MeasureTime frameDescription
Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paintsafter paint two (T1, approx. after 2 minutes) and after paint three (T2; approx. after 3 minutes) before start of surgeryProportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints
Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paintsafter 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026