Custom Surgical Tray in ACLR Procedure

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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Procedure: Anterior Cruciate Ligament reconstruction (ACLR)

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • UHToulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patient refusing to participate.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight of trash packages	Compared the weight in grams of trash packages between control and experimental group	1 day
Number of TRASH packages	Compared the Number of trash packages between control and experimental group	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ACTUAL): April 15, 2021
• Study Completion (ACTUAL): August 12, 2021

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (ACTUAL): October 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Custom Surgical Tray; Sustainable Development
• Other Study ID Numbers: RnIPH 2021-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No