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Completed

NCT Number: NCT05791734

Validation of Preoperative Shower Quality Assessment by ATPmetry (PRODOUCH'Eval)

According to the 2013 guidelines of the French Society for Hospital Hygiene (SF2H), it is recommended to carry out at least one preoperative shower, with an antiseptic soap or a mild soap as close as possible to the operation. This preoperative shower aims to eliminate dirt and make the skin clean to facilitate the subsequent action of the antiseptic in the operating theatre. Thus, detersion is no longer carried out systematically but is only recommended in the presence of soiled skin. The preoperative shower, and the verification of its effectiveness, therefore become essential steps in the preoperative skin preparation. Indeed, the cleanliness of the skin influences the quality of the antisepsis performed in the operating theatre.

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen University Hospital

Rouen, France

About this study

This study aims to evaluate a simple and objective method of measuring preoperative skin cleanliness (by swabbing and ATPmetry), in order to eventually standardise this method for routine practice.

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients inclusion criteria:

  • Age greater than or equal to 18 years
  • 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

The following patients will be excluded from the study

  • 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

Treatment and study plan

assessing preoperative skin cleanliness

Other

2 skin swabs on surgical incision sites and direct skin visual observation by a nurse

Primary outcomes

  1. innovative method

    Time frame: before surgery

    preoperative skin cleanliness as assessed by ATPmetry

  2. reference method

    Time frame: before surgery

    preoperative skin cleanliness as assessed by direct visual observation by a nurse

Secondary outcomes

  1. visual observation

    Time frame: before surgery

    Visual observation of the cleanliness of one of the two swabs before analysis by ATPmetry. This immediate observation will be made by a second nurse (unaware of the first nurse's judgement of skin cleanliness), who will assess skin cleanliness as "unsatisfactory" if the swab is stained.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Validation of Preoperative Shower Quality Assessment by ATPmetry

Acronym: PRODOUCH'Eval

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Sep 24, 2025

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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