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A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039906
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer). Install ANDY(Automatic Needle Destroyer) in the ER, and evaluate the system by comparing the efficiency of the work, usability, actual decrease ratio of needlestick injury between using the automated needle processing system and not using it.

Condition or disease Intervention/treatment Phase
Needle Stick Injuries Device: Removal of needle with using ANDYs Not Applicable

Detailed Description:
  1. Background The most frequent occupational injury is exposure to blood and fluid by needlestick injury. Needlestick injuries can result in serious infections if appropriate infection control measures are not taken promptly.

    Since the use of safety devices are not popularly used, the needle and syringe are mostly taken into pieces by physical ways. There are some cases that the needle and syringe is not separated, and the entire syringe can be put directly into the waste container. There is also a problem that it takes a lot of time and efforts to remove needles from syringes. In addition, the existing safety mechanism is physical methods such as pulling out the needle, damaging or cutting the needle, or using heat to the needle, or melting it by using chemicals. It is a semi-manual since you have to wait holding the syringe during the process, and it is inconvenient to use considering a busy medical environment.

    Therefore, we developed ANDY(Automatic Needle Destroyer) that can be introduced at a convenient and reasonable cost, and try to objectively evaluate the utility of ANDY in a clinical environment.

  2. Purpose The purpose of this study is to Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety of the system.
  3. Design : RCT (randomized controlled trial)
  4. Setting: EMERGENCY CENTER at the Samsung Medical Center
  5. Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)
  6. Intervention :

    6-1) 1st Week : Removal of needle with existing method

    • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
    • Identify the number of syringes processed by existing method.
    • Do survey after 1st week

    6-2) 2nd week: Prepare for using ANDYs

    • Provide clinicians with instruction how to use ANDY
    • Install 10 ANDYs in the ER.

    6-3) 3rd week : Removal of needle with using ANDYs

    • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
    • Identify the number of syringes processed by ANDY.
    • After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees feel those are necessary.
  7. Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)
  8. Study period : 3 weeks
  9. Satisfaction survey: SUS and adjective score

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-institutional Study to Assess the Impact of ANDY(Automatic Needle Destroyer) to the Medical Staffs in Terms of Working Efficiency Assessed by Working Time and Satisfaction Assessed by Usability and Safety Using SUS Score and Survey
Actual Study Start Date : September 2, 2019
Actual Primary Completion Date : September 23, 2019
Actual Study Completion Date : September 23, 2019

Arm Intervention/treatment
No Intervention: Removal of needle with existing method
Participants will remove needles from syringes with the existing method like they are already doing. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Experimental: Removal of needle with using ANDYs
Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)
Device: Removal of needle with using ANDYs
  1. ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days
  2. Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.

    Identify the number of syringes processed by ANDY.

  3. After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary.




Primary Outcome Measures :
  1. Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not [ Time Frame: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system) ]
    - Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.


Secondary Outcome Measures :
  1. Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not [ Time Frame: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system) ]
    - Comparison of the usability between using the automated needle processing system and not using it by doing survey after 1st week and 3rd week and Interview after 3rd week( Scoring by the answers of the Questionnaire of Satisfaction (SUS) and adjective score)

  2. Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not [ Time Frame: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system) ]
    - Comparison of the number of accidents of the needlestick injuries between using the automated needle processing system and not using it.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medical staff of the ER
  • adult ER medical staff over 19 years of age
  • A subject who voluntarily agrees and signs

Exclusion Criteria:

•A subject who did not agree with this study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039906


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: TAERIM KIM, Doctoral Samsung Medical Center
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04039906    
Other Study ID Numbers: 2019-05-112
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
Efficiency,Usability,Safety
Additional relevant MeSH terms:
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Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries