Custom Surgical Tray in ACLR Procedure

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569889
• Other study ID #: RnIPH 2021-104
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: August 12, 2021

Study information

• Verified date: October 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 12, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 years old patients

• patient necessitating a Anterior Cruciate Ligament reconstruction

Exclusion Criteria:

• patient refusing to participate.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Procedure:
• Anterior Cruciate Ligament reconstruction (ACLR)
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.

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preparation time of the trolley	Compared the number of minutes to prepare the trolley between control and experimental group	1 day
Primary	Opening time of the instruments	Compared the number of minutes to open all the instrument between control and experimental group	1 day
Primary	Sorting time of the waste	Compared the number of minutes to sorting of the waste between control and experimental group	1 day
Secondary	weight of trash packages	Compared the weight in grams of trash packages between control and experimental group	1 day
Secondary	Number of TRASH packages	Compared the Number of trash packages between control and experimental group	1 day