Validation of Preoperative Shower Quality Assessment by ATPmetry

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Ambulatory Surgical Procedures

Clinical Trial Details

NCT number	NCT05791734
Study type	Observational
Source	University Hospital, Rouen
Contact	Marion LEFEBVRE, PhD
Phone	+33 2 32 88 88 82
Email	marion.lefebvre@chu-rouen.fr
Status	Not yet recruiting
Phase
Start date	April 1, 2023
Completion date	June 1, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms