Ambulatory Surgical ProceduresPRODOUCH'EvalNCT05791734
Validation of Preoperative Shower Quality Assessment by ATPmetry (PRODOUCH'Eval)
An observational study of Ambulatory Surgical Procedures, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Surgical Procedures
- What is being tested?
- assessing preoperative skin cleanliness
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 12 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with ambulatory surgical procedures
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ambulatory Surgical Procedures
- Being tested
- assessing preoperative skin cleanliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessing preoperative skin cleanlinessOther
2 skin swabs on surgical incision sites and direct skin visual observation by a nurse
| Study group | Role | What they receive |
|---|---|---|
| assessing preoperative skin cleanliness | 2 skin swabs for ATPmetry measurement and direct skin visual observation by a nurse Receives: Other: assessing preoperative skin cleanliness |
What is being measured
The primary outcome is the main question the study is designed to answer.
innovative method
preoperative skin cleanliness as assessed by ATPmetry
Measured: before surgery
reference method
preoperative skin cleanliness as assessed by direct visual observation by a nurse
Measured: before surgery
Secondary outcomes (1)
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.
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Apr 2023
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791734
- Sponsor's protocol ID
- 2022/0178/OB
- Acronym
- PRODOUCH'Eval
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Preoperative Shower Quality Assessment by ATPmetry
- ClinicalTrials.gov ID
- NCT05791734
- Acronym / sponsor ID
- PRODOUCH'Eval / 2022/0178/OB
- Conditions
- Ambulatory Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessing preoperative skin cleanliness | – | Other: assessing preoperative skin cleanliness2 skin swabs for ATPmetry measurement and direct skin visual observation by a nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with ambulatory surgical procedures
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessing preoperative skin cleanliness2 skin swabs on surgical incision sites and direct skin visual observation by a nurse | Other | assessing preoperative skin cleanliness |
Primary outcome
innovative method
Time frame: before surgery
preoperative skin cleanliness as assessed by ATPmetry
reference method
Time frame: before surgery
preoperative skin cleanliness as assessed by direct visual observation by a nurse
1 secondary outcome
visual observation
Time frame: before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Surgical Procedures, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
innovative method (time frame: before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.