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

Sponsor
University Hospital, Rouen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04820075
Collaborator
(none)
1,000
1
36

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: improvement of preoperative shower
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
stepped wedged randomizationstepped wedged randomization
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. skin cleanliness [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.

Secondary Outcome Measures

  1. occurrence of a surgical site infection [30 days after surgery]

    Occurrence of a surgical site infection (SSI)

  2. postponement of surgery [Within 8 hours after shower]

    Postponement of surgery due to insufficient cleanliness (no go)

  3. need for detersion in the operating room [Within 8 hours after shower]

    Need for debridement in the operating room for areas of surgery for which it is not systematic

  4. patient's satisfaction regarding the preoperative shower [Within 1 month after shower]

    Patient satisfaction with the preoperative shower

  5. healthcare workers' satisfaction regarding the preoperative shower [Within 1 month after shower]

    Satisfaction of caregivers responsible for the care of preoperative patients in the care unit and in the operating room

  6. frequency of skin cleanliness assesment by healthcare workers [Within 8 hours after shower]

    Verification of cleanliness by the caregiver (patient declarative data).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT04820075
Other Study ID Numbers:
  • 2019/0413/OB
First Posted:
Mar 29, 2021
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Rouen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2021