Clinical trial NCT04820075: Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
Official title: Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Surgical Site Infection
Keywords: surgery
surgical site infection
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: stepped wedged randomization
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: skin cleanliness
timeFrame: at the time of surgery
Secondary outcomes:
measure: occurrence of a surgical site infection
timeFrame: 30 days after surgery
measure: postponement of surgery
timeFrame: Within 8 hours after shower
measure: need for detersion in the operating room
timeFrame: Within 8 hours after shower
measure: patient's satisfaction regarding the preoperative shower
timeFrame: Within 1 month after shower
measure: healthcare workers' satisfaction regarding the preoperative shower
timeFrame: Within 1 month after shower
measure: frequency of skin cleanliness assesment by healthcare workers
timeFrame: Within 8 hours after shower
Other outcomes:
Locations:
Study officials:
References: