Evaluating the Impact of the Intervention of a Pharmacist... | NCT04423250

Studies
Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical DeviceS

NCT04423250

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Feb 13, 2025Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Surgery

Interventions

impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2018Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Jun 5, 2020

First Submission Date that Met QC Criteria

Jun 8, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices	Other	- Failure to trace, Lack of product information, absence of product in the operating room

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
identify compliance with the appropriate use of sterile medical devices		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- The patient must be a member or beneficiary of a health insurance plan.
The patient is managed for scheduled surgery (full hospitalization or outpatient) in the UDG (Urology Digestive Gynecology) operating room.

Exclusion Criteria:

- The subject is in a period of exclusion determined by a previous study.
The subject is under judicial protection.
The subject (or his/her legal representative) has expressed his/her opposition to participate in the study.
The patient is undergoing emergency surgery in the UDG (Urology Digestive Gynecology) operating room.
It is not possible to give informed information about the subject.

Translated with www.DeepL.com/Translator (free version)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized for scheduled surgery in the UDG (Urology Digestive Gynecology) operating room.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de NIMES		Nîmes		30029	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.