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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
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgery focused on measuring surgery, surgical site infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    March 12, 2021
    Last Updated
    March 9, 2023
    Sponsor
    University Hospital, Rouen
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    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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