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Completed

NCT Number: NCT05569889

Custom Surgical Tray in ACLR Procedure

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UHToulouse

Toulouse, 31059, France

About this study

To determine the social impact, the study assess the quality of life at work by measuring the difference, after implementing CST, in time needed for preparation of the trolley before entering the OR, for opening the instruments necessary by the surgical and circulating certified perioperative nurse (CNOR) in the Operating Room (OR), and for sorting the waste derived from the instrument's packages between plastic and paper after the intervention. In addition, the study assessed the biomechanical risk factors related to musculoskeletal disorders by evaluating the number of movements made by the CNOR when opening the instruments and sorting the waste, with and without CST. Finally, the study evaluate CNOR and surgeon's satisfaction after the implementation of CST.

To determine the ecologic impact, the difference in the number and weight of waste due to packaging of the disposable instruments, with and without CST was evaluated.

To determine the economic impact, the difference in cost of the instruments used, with and without CST was evaluated.

The hypothesis is that the use of CST enhances Sustainable Development (SD) by maintaining social development and environment protection, despite a possible additional cost.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patient refusing to participate.

Treatment and study plan

Anterior Cruciate Ligament reconstruction (ACLR)

Procedure

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.

Primary outcomes

  1. Preparation time of the trolley

    Time frame: 1 day

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

  2. Opening time of the instruments

    Time frame: 1 day

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

  3. Sorting time of the waste

    Time frame: 1 day

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

Secondary outcomes

  1. weight of trash packages

    Time frame: 1 day

    Compared the weight in grams of trash packages between control and experimental group

  2. Number of TRASH packages

    Time frame: 1 day

    Compared the Number of trash packages between control and experimental group

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Impact of Implementing of Custom Surgical Tray (CST) in Anterior Cruciate Ligament Reconstruction Procedure on Sustainable Development.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2022
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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