Surgical Site InfectionPAINTSNCT03859375
Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections
An observational study of Surgical Site Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- microbial skin counts in the disinfection area after paints of skin disinfectants
- How many people
- 239 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2019to 8 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Adult patients undergoing elective cardiac surgery at the study site
- Adult patients undergoing elective abdominal surgery at the study site
- Provision of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Basel
About this study
Official title: Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections; PAINTS Study
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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- microbial skin counts in the disinfection area after paints of skin disinfectants
- Keywords
- Colony forming units, preoperative skin disinfection, microbial skin counts
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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])
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: microbial skin counts in the disinfection area after paints of skin disinfectants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints
Measured: 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
Measured: after paint two (T1, approx. after 2 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start29 Jan 2019
- Primary completion1 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Andreas Widmer, Prof. Dr. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859375
- Sponsor's protocol ID
- 2018-02292; me18Widmer2
- Other IDs
- 2018
- Acronym
- PAINTS
- Status last verified
- Jun 2020
- First submitted
- 27 Feb 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections; PAINTS Study
- ClinicalTrials.gov ID
- NCT03859375
- Acronym / sponsor ID
- PAINTS / 2018-02292; me18Widmer2
- Conditions
- Surgical Site Infection
- Keywords
- Colony forming units, preoperative skin disinfection, microbial skin counts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 paints of skin disinfectants | – | Other: microbial skin counts in the disinfection area after paints of skin disinfectantsStandard 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. |
| 3 paints of skin disinfectants | – | Other: microbial skin counts in the disinfection area after paints of skin disinfectantsStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Adult patients undergoing elective cardiac surgery at the study site
- Adult patients undergoing elective abdominal surgery at the study site
- Provision of informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microbial skin counts in the disinfection area after paints of skin disinfectantsmicrobial skin counts in the disinfection area after 2 and 3 paints of skin disinfectants (chlorhexidine in alcohol [CHX] and povidone iodine in alcohol [PI]) | Other | 2 paints of skin disinfectants, 3 paints of skin disinfectants |
Primary outcome
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
2 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
Time frame: after paint two (T1, approx. after 2 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Widmer, Prof. Dr. MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.