Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery (PRODOUCH'OP)
Primary Purpose
Surgery, Surgical Site Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
improvement of preoperative shower
Sponsored by
About this trial
This is an interventional prevention trial for Surgery focused on measuring surgery, surgical site infection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Process about performance of the preoperative shower
Arm Description
Implementation of a process aimed at improving the preoperative shower in programmed surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
occurrence of a surgical site infection
Occurrence of a surgical site infection (SSI)
postponement of surgery
Postponement of surgery due to insufficient cleanliness (no go)
need for detersion in the operating room
Need for debridement in the operating room for areas of surgery for which it is not systematic
patient's satisfaction regarding the preoperative shower
Patient satisfaction with the preoperative 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
frequency of skin cleanliness assesment by healthcare workers
Verification of cleanliness by the caregiver (patient declarative data).
Full Information
NCT ID
NCT04820075
First Posted
March 12, 2021
Last Updated
March 9, 2023
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT04820075
Brief Title
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
Acronym
PRODOUCH'OP
Official Title
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Surgical Site Infection
Keywords
surgery, surgical site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
stepped wedged randomization
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Process about performance of the preoperative shower
Arm Type
Other
Arm Description
Implementation of a process aimed at improving the preoperative shower in programmed surgery
Intervention Type
Behavioral
Intervention Name(s)
improvement of preoperative shower
Intervention Description
Process about preoperative shower
Primary Outcome Measure Information:
Title
skin cleanliness
Description
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.
Time Frame
at the time of surgery
Secondary Outcome Measure Information:
Title
occurrence of a surgical site infection
Description
Occurrence of a surgical site infection (SSI)
Time Frame
30 days after surgery
Title
postponement of surgery
Description
Postponement of surgery due to insufficient cleanliness (no go)
Time Frame
Within 8 hours after shower
Title
need for detersion in the operating room
Description
Need for debridement in the operating room for areas of surgery for which it is not systematic
Time Frame
Within 8 hours after shower
Title
patient's satisfaction regarding the preoperative shower
Description
Patient satisfaction with the preoperative shower
Time Frame
Within 1 month after shower
Title
healthcare workers' satisfaction regarding the preoperative shower
Description
Satisfaction of caregivers responsible for the care of preoperative patients in the care unit and in the operating room
Time Frame
Within 1 month after shower
Title
frequency of skin cleanliness assesment by healthcare workers
Description
Verification of cleanliness by the caregiver (patient declarative data).
Time Frame
Within 8 hours after shower
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VERONIQUE MERLE
Phone
0232888882
Email
veronique.merle@chu-rouen.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
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