Needlestick InjuriesNCT00536289
Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth
A study testing Blunt needle in people with Needlestick Injuries, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Needlestick Injuries
- What is being tested?
- Blunt needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2006
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obstetric laceration requiring suturing
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29466
About this study
Official title: The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair
The hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon.
- Conditions
- Needlestick Injuries
- Being tested
- Blunt needle
- Keywords
- Blunt needles, obstetric lacerations, Needlestick injuries, Needlestick injuries to physicians
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blunt needleDevice
Blunt tipped suture needle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sharp needles Receives: Device: Blunt needle |
| 2 | Experimental | Blunt tipped needles Receives: Device: Blunt needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Holes in surgeons gloves
Measured: After surgical repair
Secondary outcomes (1)
Surgeon satisfaction with the needle assignment
Measured: After the surgical repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startJan 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needlestick InjuriesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Scott A Sullivan, MD MSCR, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536289
- Sponsor's protocol ID
- MUSC HR # 10870
- Status last verified
- Jan 2006
- First submitted
- 26 Sep 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair
- ClinicalTrials.gov ID
- NCT00536289
- Acronym / sponsor ID
- MUSC HR # 10870
- Conditions
- Needlestick Injuries
- Keywords
- Blunt needles, obstetric lacerations, Needlestick injuries, Needlestick injuries to physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 27 Sep 2007 (estimated)
- 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.
The hypothesis for this study is that use of blunt tipped needles used during the repair of an episiotomy (tear in the vagina after childbirth) will result in fewer needlestick injuries to the surgeon.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Blunt needleSharp needles |
| 2 | Experimental | Device: Blunt needleBlunt tipped needles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obstetric laceration requiring suturing
Key exclusion criteria (1 listed)
- < 18 years old
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 |
|---|---|---|
| Blunt needleBlunt tipped suture needle | Device | 1, 2 |
Primary outcome
Holes in surgeons gloves
Time frame: After surgical repair
1 secondary outcome
Surgeon satisfaction with the needle assignment
Time frame: After the surgical repair
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 27 Sep 2007.
Related trials for Needlestick 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.
Scott A Sullivan, MD MSCR principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blunt needle in people with Needlestick Injuries, run by Medical University of South Carolina at 1 site in United States.
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 1 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 27 Sep 2007. 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 United States. 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?
Holes in surgeons gloves (time frame: After surgical repair). 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 27 Sep 2007.