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

NCT04820075 | Terminated

• 1 other identifier: 2019/0413/OB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Surgical Site Infection

Keywords

surgery; surgical site infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• occurrence of a surgical site infection

  30 days after surgery

• postponement of surgery

  Within 8 hours after shower

• need for detersion in the operating room

  Within 8 hours after shower

• patient's satisfaction regarding the preoperative shower

  Within 1 month after shower

• healthcare workers' satisfaction regarding the preoperative shower

  Within 1 month after shower

Study Arms (1)

Process about performance of the preoperative shower

OTHER

Implementation of a process aimed at improving the preoperative shower in programmed surgery

Behavioral: improvement of preoperative shower

Interventions

improvement of preoperative shower BEHAVIORAL

Process about preoperative shower

Process about performance of the preoperative shower

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de ROUEN

Rouen, France

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped wedged randomization

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 29, 2021
• Study Start: October 21, 2021
• Primary Completion: July 27, 2025
• Study Completion: July 27, 2025
• Last Updated: September 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)