SurgeryPRODOUCH'OPNCT04820075
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
A study testing improvement of preoperative shower in people with Surgery and Surgical Site Infection, run by University Hospital, Rouen at 1 site in France.
Trial summary
The aim of the project is to evaluate the effectiveness, on the skin cleanliness of the patient on arrival at the operating room, of an intervention aimed at improving the performance of the preoperative shower, for patients undergoing a planned surgical intervention in an orthopedic surgery department, digestive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Surgical Site Infection
- What is being tested?
- improvement of preoperative shower
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2021to 27 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- age 18 and over, and
- scheduled for surgery (outpatient or full hospitalization) in one of the following specialties: orthopedics, digestive (including bariatric surgery), gynecological, thoracic, vascular, and
- having read and understood the briefing note and not showing up for research.
Who cannot join
- operated on urgently, or
- operated on for an intervention other than orthopedics, gynecology, digestive surgery, vascular surgery, or
- having received a toilet in bed, or
- having expressed their opposition to the research.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project is to evaluate the effectiveness, on the skin cleanliness of the patient on arrival at the operating room, of an intervention aimed at improving the performance of the preoperative shower, for patients undergoing a planned surgical intervention in an orthopedic surgery department, digestive, gynecological, thoracic, or vascular.
Read the detailed description
The project will be realized in 2 phases.
- The first phase of the project will consist of a sociological survey conducted with caregivers and patients in the care sectors participating in the study. This component sociological research will be carried out on the basis of in-depth interviews with caregivers (nurses and nursing assistants) from the departments concerned by research and patients. The expected sample, subject to data saturation, is 40 caregivers and 20 patients. These in-depth and non-directive interviews will be carried out by a sociologist and will aim to explore the way in which healthcare professionals see their activity professional, the relationship they maintain with the various members of the healthcare team, their perceptions of the body, privacy and hygiene of patients, but also to explore the representations of caregivers of the preoperative shower and of the relationship with caregivers during phases of explanation, possible help with the shower, and control of cleanliness cutaneous. These interviews will identify the representations of caregivers and patients with the aim of establishing a procedure for caregivers to improve care of the preoperative shower. In view of the statements of patients and caregivers concerning preparing for the preoperative shower and checking skin cleanliness during the Survey exploratory, it appears necessary to improve and formalize the protocol. Investigation will thus establish a base of knowledge necessary to establish a care procedure giving an account of the roles of each person, caregivers and patients.
- Conditions
- Surgery, Surgical Site Infection
- Being tested
- improvement of preoperative shower
- Keywords
- surgery, surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
improvement of preoperative showerBehavioural
Process about preoperative shower
| Study group | Role | What they receive |
|---|---|---|
| Process about performance of the preoperative shower | Other | Implementation of a process aimed at improving the preoperative shower in programmed surgery Receives: Behavioral: improvement of preoperative shower |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin cleanliness
The criterion for evaluating the effectiveness of the preoperative shower, consistent with national recommendations, is skin cleanliness, defined as the absence of macroscopic stains on the skin.
Measured: at the time of surgery
Secondary outcomes (6)
occurrence of a surgical site infection
Occurrence of a surgical site infection (SSI)
Measured: 30 days after surgery
postponement of surgery
Postponement of surgery due to insufficient cleanliness (no go)
Measured: Within 8 hours after shower
need for detersion in the operating room
Need for debridement in the operating room for areas of surgery for which it is not systematic
Measured: Within 8 hours after shower
patient's satisfaction regarding the preoperative shower
Patient satisfaction with the preoperative shower
Measured: Within 1 month after shower
healthcare workers' satisfaction regarding the preoperative shower
Satisfaction of caregivers responsible for the care of preoperative patients in the care unit and in the operating room
Measured: Within 1 month after shower
frequency of skin cleanliness assesment by healthcare workers
Verification of cleanliness by the caregiver (patient declarative data).
Measured: Within 8 hours after shower
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start21 Oct 2021
- Primary completion27 Jul 2025
- Study completion27 Jul 2025
Why it stopped: impossible to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- stepped wedged randomization
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT04820075
- Sponsor's protocol ID
- 2019/0413/OB
- Acronym
- PRODOUCH'OP
- Status last verified
- Sep 2024
- First submitted
- 12 Mar 2021
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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
- Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
- ClinicalTrials.gov ID
- NCT04820075
- Acronym / sponsor ID
- PRODOUCH'OP / 2019/0413/OB
- Conditions
- Surgery, Surgical Site Infection
- Keywords
- surgery, surgical site infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: impossible to continue the study
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 27 Jul 2025 (actual)
- Study completion
- 27 Jul 2025 (actual)
- First posted
- 29 Mar 2021 (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.
The aim of the project is to evaluate the effectiveness, on the skin cleanliness of the patient on arrival at the operating room, of an intervention aimed at improving the performance of the preoperative shower, for patients undergoing a planned surgical intervention in an orthopedic surgery department, digestive, gynecological, thoracic, or vascular.
Detailed description
The project will be realized in 2 phases.
- The first phase of the project will consist of a sociological survey conducted with caregivers and patients in the care sectors participating in the study. This component sociological research will be carried out on the basis of in-depth interviews with caregivers (nurses and nursing assistants) from the departments concerned by research and patients. The expected sample, subject to data saturation, is 40 caregivers and 20 patients. These in-depth and non-directive interviews will be carried out by a sociologist and will aim to explore the way in which healthcare professionals see their activity professional, the relationship they maintain with the various members of the healthcare team, their perceptions of the body, privacy and hygiene of patients, but also to explore the representations of caregivers of the preoperative shower and of the relationship with caregivers during phases of explanation, possible help with the shower, and control of cleanliness cutaneous. These interviews will identify the representations of caregivers and patients with the aim of establishing a procedure for caregivers to improve care of the preoperative shower. In view of the statements of patients and caregivers concerning preparing for the preoperative shower and checking skin cleanliness during the Survey exploratory, it appears necessary to improve and formalize the protocol. Investigation will thus establish a base of knowledge necessary to establish a care procedure giving an account of the roles of each person, caregivers and patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- stepped wedged randomization
| Arm | Type | Receives |
|---|---|---|
| Process about performance of the preoperative shower | Other | Behavioral: improvement of preoperative showerImplementation of a process aimed at improving the preoperative shower in programmed surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 and over, and
- scheduled for surgery (outpatient or full hospitalization) in one of the following specialties: orthopedics, digestive (including bariatric surgery), gynecological, thoracic, vascular, and
- having read and understood the briefing note and not showing up for research.
Key exclusion criteria (4 listed)
- operated on urgently, or
- operated on for an intervention other than orthopedics, gynecology, digestive surgery, vascular surgery, or
- having received a toilet in bed, or
- having expressed their opposition to the research.
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 |
|---|---|---|
| improvement of preoperative showerProcess about preoperative shower | Behavioural | Process about performance of the preoperative shower |
Primary outcome
skin cleanliness
Time frame: at the time of surgery
The criterion for evaluating the effectiveness of the preoperative shower, consistent with national recommendations, is skin cleanliness, defined as the absence of macroscopic stains on the skin.
6 secondary outcomes
occurrence of a surgical site infection
Time frame: 30 days after surgery
postponement of surgery
Time frame: Within 8 hours after shower
need for detersion in the operating room
Time frame: Within 8 hours after shower
patient's satisfaction regarding the preoperative shower
Time frame: Within 1 month after shower
healthcare workers' satisfaction regarding the preoperative shower
Time frame: Within 1 month after shower
frequency of skin cleanliness assesment by healthcare workers
Time frame: Within 8 hours after shower
Results and safety
The study was stopped early (reason given: impossible to continue the study). Results are not available in the source record.
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?
A study testing improvement of preoperative shower in people with Surgery and Surgical Site Infection, 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 3 inclusion and 4 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: stopped early, 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 was stopped early (reason given: impossible to continue the study). Results are not available in the source record.
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?
skin cleanliness (time frame: at the time of surgery). 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.