Clinical trial NCT05569889: Custom Surgical Tray in ACLR Procedure
Official title: Impact of Implementing of Custom Surgical Tray (CST) in Anterior Cruciate Ligament Reconstruction Procedure on Sustainable Development.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Custom Surgical Tray
Sustainable Development
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All surgery of Anterior Cruciate Ligament reconstruction were study during the period between 15 february 2021 and 15 August 2021.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patient refusing to participate.

Primary outcomes:
measure: Preparation time of the trolley
timeFrame: 1 day
measure: Opening time of the instruments
timeFrame: 1 day
measure: Sorting time of the waste
timeFrame: 1 day
Secondary outcomes:
measure: weight of trash packages
timeFrame: 1 day
measure: Number of TRASH packages
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Etienne CAVAIGNAC
role: PRINCIPAL_INVESTIGATOR
References: