Needle Stick InjuriesNCT04039906
A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)
A study testing Removal of needle with using ANDYs in people with Needle Stick Injuries, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Needle Stick Injuries
- What is being tested?
- Removal of needle with using ANDYs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Sep 2019to 23 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical staff of the ER
- adult ER medical staff over 19 years of age
- A subject who voluntarily agrees and signs
Who cannot join
- •A subject who did not agree with this study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
- 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.
- 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.
- Design : RCT (randomized controlled trial)
- Setting: EMERGENCY CENTER at the Samsung Medical Center
- Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)
- 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.
- Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)
- Study period : 3 weeks
- Satisfaction survey: SUS and adjective score
- Conditions
- Needle Stick Injuries
- Being tested
- Removal of needle with using ANDYs
- Keywords
- Efficiency,Usability,Safety
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of needle with using ANDYsDevice
- ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days
- 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 felt those are necessary.
| Study group | Role | What they receive |
|---|---|---|
| Removal of needle with existing method | No intervention | 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.) |
| Removal of needle with using ANDYs | Experimental | Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.) Receives: Device: Removal of needle with using ANDYs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.
Measured: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
Secondary outcomes (2)
Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not
- 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)
Measured: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not
- Comparison of the number of accidents of the needlestick injuries between using the automated needle processing system and not using it.
Measured: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start2 Sep 2019
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle Stick InjuriesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TAERIM KIM, Doctoral, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039906
- Sponsor's protocol ID
- 2019-05-112
- Status last verified
- May 2019
- First submitted
- 15 Jul 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04039906
- Acronym / sponsor ID
- 2019-05-112
- Conditions
- Needle Stick Injuries
- Keywords
- Efficiency,Usability,Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- Design : RCT (randomized controlled trial)
- Setting: EMERGENCY CENTER at the Samsung Medical Center
- Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)
- 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.
- Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)
- Study period : 3 weeks
- Satisfaction survey: SUS and adjective score
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removal of needle with existing method | No intervention | –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.) |
| Removal of needle with using ANDYs | Experimental | Device: Removal of needle with using ANDYsParticipants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medical staff of the ER
- adult ER medical staff over 19 years of age
- A subject who voluntarily agrees and signs
Key exclusion criteria (1 listed)
- •A subject who did not agree with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of needle with using ANDYs1. 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. | Device | Removal of needle with using ANDYs |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Needle Stick Injuries
Enrolling by invitationObservational study
A Study of VAX-ID® 2200, a New Device for Intradermal Injections
Sharps Injuries
Recruiting
ShotBlocker During Intramuscular Injection Randomized Control Trial
Neonatal Pain
Not yet recruiting
AI-Supported Gamified Training for Sharps Injury Prevention in Nurses
Sharps Injuries, Needlestick Injuries
Active, not recruitingObservational study
Determination of NSI Regarding Bloodborne Pathogens Among Healthcare Workers at Tertiary Care, DIK
Needle Stick Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TAERIM KIM, Doctoral principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of needle with using ANDYs in people with Needle Stick Injuries, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.