Custom Surgical Tray in ACLR Procedure

NCT ID: NCT05569889

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2021-08-12

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

control group

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

Anterior Cruciate Ligament reconstruction (ACLR)

Intervention Type: 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.

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.

Anterior Cruciate Ligament reconstruction (ACLR)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patient refusing to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne CAVAIGNAC

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

UHToulouse

Toulouse, , France

Countries

France

Other Identifiers

RnIPH 2021-104

Identifier Type: -

Identifier Source: org_study_id