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

NCT05791734 | Completed

• 1 other identifier: 2022/0178/OB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ambulatory Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• visual observation

  before surgery

Study Arms (1)

assessing preoperative skin cleanliness

2 skin swabs for ATPmetry measurement and direct skin visual observation by a nurse

Other: assessing preoperative skin cleanliness

Interventions

assessing preoperative skin cleanliness OTHER

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

assessing preoperative skin cleanliness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with ambulatory surgical procedures

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2023
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)