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Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications (ARIBO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158181
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment
Postoperative Complications Other: Non interventional study

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Study Type : Observational
Estimated Enrollment : 9945 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery


Intervention Details:
  • 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)


Primary Outcome Measures :
  1. Occurrence of any major postoperative complications [ Time Frame: Until 30 days after hospitalization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

The study population will include adult patients receiving hip and knee prosthetic prosthetic orthopedic surgery on a scheduled and emergency first-line basis.

This choice is due to the following reasons:

This specialty requires a cutaneous approach, All these gestures are Altemeier class I or own surgery, These are frequent surgeries, the most frequent in orthopedics They are reproducible acts allowing the comparison from one center to another.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158181


Contacts
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Contact: Gabriel BIRGAND, Dr 02 40 08 70 72 gabriel.birgand@chu-nantes.fr

Locations
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France
Angers University Hospital Recruiting
Angers, France, 49100
Contact: Clément LEGEAY, Dr    02 41 35 59 34    clement.legeay@chu-angers.fr   
Principal Investigator: Clément LEGEAY, Dr         
Sub-Investigator: Laurent HUBERT, Dr         
Vendée Hospital Recruiting
La Roche sur Yon, France, 85000
Contact: Guillaume KAC, Dr    02 51 44 65 71    guillaume.kac@chd-vendee.fr   
Principal Investigator: Guillaume KAC, Dr         
Pré surgical clinic Recruiting
Le Mans, France, 72000
Contact: Laurence JUHEL-VOOG, Dr    02 43 77 57 75    infectiologue@clinique-du-pre.fr   
Principal Investigator: Laurence JUHEL-VOOG, Dr         
Le Mans Hospital Recruiting
Le Mans, France, 72037
Contact: Céline COROLLER-BEC, Dr    02 43 43 28 09    ccorollerbec@ch-lemans.fr   
Principal Investigator: Céline COROLLER-BEC, Dr         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Gabriel BIRGAND, Dr    02 40 08 70 72    gabriel.birgand@chu-nantes.fr   
Principal Investigator: Gabriel BIRGAND, Dr         
Sub-Investigator: Didier LEPELLETIER, Pr         
H.P. Confluent Recruiting
Nantes, France, 44277
Contact: Virginie LOUBERSAC, Dr    02 28 25 56 90    virginie.loubersac@groupeconfluent.fr   
Principal Investigator: Virginie LOUBERSAC, Dr         
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Rishma AMARSY, Dr    0149958569    rishma.amarsy@aphp.fr   
IMM Recruiting
Paris, France, 75014
Contact: Jacques- Yves NIZOU, Dr    0156616069    jacquesyves.nizou@imm.fr   
Hôpital Beaujon Recruiting
Paris, France, 92118
Contact: Simone NEROME, Dr    0140815089    simone.nerome@aphp.fr   
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: Pierre-Yves DONNIO, Pr    02 99 28 43 21    yves.donnio@chu-rennes.fr   
Principal Investigator: Pierre-Yves DONNIO, Pr         
Saint Grégoire private hospital Recruiting
Saint-Grégoire, France, 35760
Contact: Jean-Claude CHAPALAIN, Dr    02 99 23 33 33    jcchapalain@vivalto-sante.com   
Principal Investigator: Jean-Claude CHAPALAIN, Dr         
Sante Atlantique Recruiting
Saint-Herblain, France, 44819
Contact: Sophie MILLET, Dr    02 40 95 93 93    DrMillet@polyclinique-atlantique.fr   
Principal Investigator: Sophie MILLET, Dr         
Saint-Nazaire Hospital Recruiting
Saint-Nazaire, France, 44600
Contact: Séverine GALLAIS, Dr    02 72 27 85 36    s.gallais@ch-saintnazaire.fr   
Principal Investigator: Séverine GALLAIS, Dr         
Tours University Hospital Recruiting
Tours, France, 37044
Contact: Nathalie VAN DER MEE, Dr    02 34 38 94 30    N.VANDERMEE@chu-tours.fr   
Principal Investigator: Nathalie VAN DER MEE, Dr         
Sub-Investigator: Philippe ROSSET, Pr         
Saint-Léonard Clinic Recruiting
Trélazé, France, 49800
Contact: Virginie ROUE, Dr    02 41 41 74 08    Virginie.roue@villagesante.fr   
Principal Investigator: Virginie ROUE, Dr         
Vannes Hospital Recruiting
Vannes, France, 56000
Contact: Stéphane LELIMOUZIN, Dr    02 97 01 41 41    stephane.lelimouzin@ch-bretagne-atlantique.fr   
Principal Investigator: Stéphane LELIMOUZIN, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Gabriel BIRGAND, Dr Nantes University Hopital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03158181    
Other Study ID Numbers: RC17_0076
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Behavior; Operational block; Monitoring; Social Sciences ; New technologies
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes