Glove PerforationsNCT00844636
A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
A study testing Sharp needle and Blunt needles in people with Glove Perforations and Needlestick Injuries, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery. 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
- Glove Perforations, Needlestick Injuries
- What is being tested?
- Sharp needle and Blunt needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2008
- 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
- Female
- Pregnant
- Undergoing a cesarean section
Who cannot join
- Under age 18
- Non-English speaking
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: A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
The objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery.
- Conditions
- Glove Perforations, Needlestick Injuries
- Being tested
- Sharp needle, Blunt needles
- Keywords
- Needlestick injuries, Glove perforations, Blunt Needles, Glove perforations of surgeons, assistants, Needlestick injuries of same
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharp needleDevice
Blunt needlesDevice
| Study group | Role | What they receive |
|---|---|---|
| Sharp Needles | Active comparator | Sharp needles to close uterus, fascia and skin during cesarean section Receives: Device: Sharp needle |
| Blunt Needles | Active comparator | Assignment to blunt needles to close uterus, fascia and skin during cesarean section Receives: Device: Blunt needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of observed glove perforations
review post-op
Measured: 1 day
Secondary outcomes (1)
Physician satisfaction with the needle assignment
Rating scale 1-5 (1 being least satisfied and 5 being very satisfied); review post-op
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startJan 2005
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glove PerforationsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Scott A Sullivan, MD, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844636
- Sponsor's protocol ID
- Blunt Needles - Cesarean
- Status last verified
- Aug 2018
- First submitted
- 12 Feb 2009
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sullivan S, Williamson B, Wilson LK, Korte JE, Soper D. Blunt needles for the reduction of needlestick injuries during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2009 Aug;114(2 Pt 1):211-216. doi: 10.1097/AOG.0b013e3181ae9b4a.
PubMed 19622979
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
- ClinicalTrials.gov ID
- NCT00844636
- Acronym / sponsor ID
- Blunt Needles - Cesarean
- Conditions
- Glove Perforations, Needlestick Injuries
- Keywords
- Needlestick injuries, Glove perforations, Blunt Needles, Glove perforations of surgeons, assistants, Needlestick injuries of same
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Feb 2009 (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 objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sharp Needles | Active comparator | Device: Sharp needleSharp needles to close uterus, fascia and skin during cesarean section |
| Blunt Needles | Active comparator | Device: Blunt needlesAssignment to blunt needles to close uterus, fascia and skin during cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Pregnant
- Undergoing a cesarean section
Key exclusion criteria (2 listed)
- Under age 18
- Non-English speaking
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 |
|---|---|---|
| Sharp needle | Device | Sharp Needles |
| Blunt needles | Device | Blunt Needles |
Primary outcome
Number of observed glove perforations
Time frame: 1 day
review post-op
1 secondary outcome
Physician satisfaction with the needle assignment
Time frame: 1 day
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 13 Aug 2018.
- Derived from this study: PubMed 19622979Sullivan S, Williamson B, Wilson LK, Korte JE, Soper D. Blunt needles for the reduction of needlestick injuries during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2009 Aug;114(2 Pt 1):211-216. doi: 10.1097/AOG.0b013e3181ae9b4a.
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 study director
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 Sharp needle and Blunt needles in people with Glove Perforations and 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 3 inclusion and 2 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 13 Aug 2018. 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?
Number of observed glove perforations (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00844636, which also lists 1 linked publication.
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 13 Aug 2018.