NCT05569889

Brief Summary

In the Toulouse University Hospital, the Custom Surgical Tray (CST) were not referenced. The nurse had to prepare and open all the components of the procedure separately. This is a long and wasteful process. CST brings together all the single-use medical devices necessary for an intervention, including draping and dressing elements, in the same single packaging. Following the new local call for tenders on draping kits, and with the aim of standardizing and rationalizing practices, the implementation of CST within the requesting blocks whose orthopedic and traumatology block has been validated. The hypothesis is that the CST would save time on preparing the trolley and on opening single-use equipment in the room while limiting the amount of waste.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

September 27, 2022

Last Update Submit

October 6, 2022

Conditions

Keywords

Custom Surgical TraySustainable Development

Outcome Measures

Primary Outcomes (3)

  • Preparation time of the trolley

    Compared the number of minutes to prepare the trolley between control and experimental group

    1 day

  • Opening time of the instruments

    Compared the number of minutes to open all the instrument between control and experimental group

    1 day

  • Sorting time of the waste

    Compared the number of minutes to sorting of the waste between control and experimental group

    1 day

Secondary Outcomes (2)

  • weight of trash packages

    1 day

  • Number of TRASH packages

    1 day

Study Arms (2)

control group

The medical staff was using the traditional surgical draping kit and single-packed sterile instruments (SPSI) that have to be opened separately

Procedure: Anterior Cruciate Ligament reconstruction (ACLR)

experimental group

The medical staff was using only the single packed CST, and containing all the necessary single-use items like surgical blades, sutures, dressing, surgical drapes, syringes, compresses, surgical gloves, jerseys.

Procedure: Anterior Cruciate Ligament reconstruction (ACLR)

Interventions

A comparison between the two groups were done regarding the three following stages: (a) the preparation time of the trolley, which is the time taken by the CNOR to recover from the reserves all the single-packed sterile instruments (SPSI) necessary for the intervention or to recover the CST (b) the opening time of the instruments by the circulating nurse who opens the packages and gives them to the surgical nurse while respecting the sterility of the items, and by the surgical nurse who prepares the table for the intervention, and (c) the sorting time of the waste between plastic and paper at the end of the intervention.

control groupexperimental group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All surgery of Anterior Cruciate Ligament reconstruction were study during the period between 15 february 2021 and 15 August 2021.

You may qualify if:

  • years old patients
  • patient necessitating a Anterior Cruciate Ligament reconstruction

You may not qualify if:

  • patient refusing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Anterior Cruciate Ligament Reconstruction

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Etienne CAVAIGNAC

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 6, 2022

Study Start

April 15, 2021

Primary Completion

April 15, 2021

Study Completion

August 12, 2021

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations