Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery

Surgery Clinical Trial

— PRODOUCH'OP  

Official title:

Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04820075
• Other study ID #: 2019/0413/OB
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Rouen
• Contact: VERONIQUE MERLE
• Phone: 0232888882
• Email: veronique.merle[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, gynecological, thoracic, or vascular.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Behavioral:
• improvement of preoperative shower
Process about preoperative shower

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

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