Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery (PRODOUCH'OP)

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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Surgical Site Infection
• Intervention / Treatment: Behavioral: improvement of preoperative shower

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • CHU de ROUEN

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. age 18 and over, and
2. scheduled for surgery (outpatient or full hospitalization) in one of the following specialties: orthopedics, digestive (including bariatric surgery), gynecological, thoracic, vascular, and
3. having read and understood the briefing note and not showing up for research.

Exclusion Criteria:

1. operated on urgently, or
2. operated on for an intervention other than orthopedics, gynecology, digestive surgery, vascular surgery, or
3. having received a toilet in bed, or
4. having expressed their opposition to the research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Process about performance of the preoperative shower; Implementation of a process aimed at improving the preoperative shower in programmed surgery	Behavioral: improvement of preoperative shower; Process about preoperative shower

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of a surgical site infection	Occurrence of a surgical site infection (SSI)	30 days after surgery
postponement of surgery	Postponement of surgery due to insufficient cleanliness (no go)	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	Within 8 hours after shower
patient's satisfaction regarding the preoperative shower	Patient satisfaction with the preoperative shower	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	Within 1 month after shower
frequency of skin cleanliness assesment by healthcare workers	Verification of cleanliness by the caregiver (patient declarative data).	Within 8 hours after shower

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): July 27, 2025
• Study Completion (Actual): July 27, 2025

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: surgery; surgical site infection
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: 2019/0413/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