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

Validation of Preoperative Shower Quality Assessment by ATPmetry

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ambulatory Surgical Procedures
• Intervention / Treatment: Other: assessing preoperative skin cleanliness

Detailed 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Marion LEFEBVRE, PhD; Phone Number: +33 2 32 88 88 82; Email: marion.lefebvre@chu-rouen.fr
• Study Contact Backup: Name: Déborah LEBEDIEFF; Phone Number: + 33 2 32 88 82 65; Email: deborah.lebedieff@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital
    • Contact: Marion LEFEBVRE; Email: marion.lefebvre@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient with ambulatory surgical procedures

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
assessing preoperative skin cleanliness; 2 skin swabs for ATPmetry measurement and direct skin visual observation by a nurse	Other: assessing preoperative skin cleanliness; 2 skin swabs on surgical incision sites and direct skin visual observation by a nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
innovative method	preoperative skin cleanliness as assessed by ATPmetry	before surgery
reference method	preoperative skin cleanliness as assessed by direct visual observation by a nurse	before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual observation	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.	before surgery

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022/0178/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No