Validation of Preoperative Shower Quality Assessment by ATPmetry (PRODOUCH'Eval)
NCT ID: NCT05791734
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2023-04-01
2023-05-12
Brief Summary
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Visual assessment of preoperative skin cleanliness by the nurse is currently the reference technique. However, a qualitative pilot study (Consiglio et al., Rech Soins Inf 2021) of nine obese patients and eleven surgical nurses revealed a lack of visual verification of skin cleanliness, which caregivers found difficult to perform. In a second multicentre study of 430 patients (Boulet et al., under review by Nursing Open), only 17% reported visual verification of skin cleanliness. Thus, this initial work highlights a barrier for caregivers to visually check preoperative skin cleanliness.
The ATPmetry method was initially developed to assess the cleanliness of surfaces. In a second phase, the manufacturer (Hygiena®) showed through a study of 20 professionals that this method also allowed the evaluation of skin cleanliness of hands after washing. This method would have the advantage of being objective, potentially improving acceptability to caregivers and patients compared to direct visual inspection of skin cleanliness. Thus, ATPmetry appears to us as a method of interest for assessing preoperative skin cleanliness, but needs to be validated for this indication.
To date, there is no other method than the simple subjective visual skin assessment by the caregiver, which is highly exposed to a bias of non-reproducibility and inter-observer variability.
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Detailed Description
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The reproducibility of the ATPmetry measurement will be assessed as well as its concordance with two other methods (visual skin inspection and visual swab inspection). An statistical analysis will assess its agreement with each of the other two methods, as compared to the agreement between the two methods.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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assessing preoperative skin cleanliness
2 skin swabs for ATPmetry measurement and direct skin visual observation by a nurse
assessing preoperative skin cleanliness
2 skin swabs on surgical incision sites and direct skin visual observation by a nurse
Interventions
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assessing preoperative skin cleanliness
2 skin swabs on surgical incision sites and direct skin visual observation by a nurse
Eligibility Criteria
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Inclusion Criteria
* patient with ambulatory surgical procedures
* Patient scheduled for a surgical procedure for which the incision site is cutaneous
* Patient covered by national health insurance
* Patient having read and understood the information letter and having expressed oral non-opposition to the research
Exclusion Criteria
* Patients scheduled for a surgical procedure with a muqueous incision site
* patients \< 18 ans
* Pregnant or breastfeeding women
* Patients who have not given their consent to participate or are unable to give consent
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2022/0178/OB
Identifier Type: -
Identifier Source: org_study_id
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