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NCT03158181 Clinical Trial

Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

Postoperative Complications Clinical Trial

— ARIBO2  

Official title:
Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03158181
Other study ID # RC17_0076
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2020

Study information
Verified date September 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.

Recruitment information / eligibility
Status Completed
Enrollment 20959
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Major patient - Patient agreeing to participate in the study - Patient who will benefit from orthopedic surgery for hip or knee arthroplasty with prosthesis placement Non-Inclusion Criteria: - Patient with previous history of surgical site infection

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non interventional study
None intervention will be conduct on patient. Only the operating room will be randomized to have an intervention or not (Bundle of measure for optimizing the discipline of personnel in the operating room)

Locations
Country Name City State
France Angers University Hospital Angers
France Vendée Hospital La Roche sur Yon
France Le Mans Hospital Le Mans
France Pré surgical clinic Le Mans
France H.P. Confluent Nantes
France Nantes University Hospital Nantes
France Hôpital Beaujon Paris
France Hôpital Lariboisière Paris
France IMM Paris
France Rennes University Hospital Rennes
France Saint Grégoire private hospital Saint-Grégoire
France Sante Atlantique Saint-Herblain
France Saint-Nazaire Hospital Saint-Nazaire
France Tours University Hospital Tours
France Saint-Léonard Clinic Trélazé
France Vannes Hospital Vannes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of any major postoperative complications Until 30 days after hospitalization
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