Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth
This study has been completed.
Sponsor:
Medical University of South Carolina
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00536289
First received: September 26, 2007
Last updated: NA
Last verified: January 2006
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | September 26, 2007 | ||||
| Last Updated Date | September 26, 2007 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Holes in surgeons gloves [ Time Frame: After surgical repair ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Surgeon satisfaction with the needle assignment [ Time Frame: After the surgical repair ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Blunt Needles do Not Reduce Needlestick Injuries to Doctors During Suturing After Child-Birth | ||||
| Official Title ICMJE | The Use of Blunt Needles Does Not Reduce Needlestick Injury During Obstetrical Laceration Repair | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Needlestick Injuries | ||||
| Intervention ICMJE | Device: Blunt needle
Blunt tipped suture needle |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 438 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00536289 | ||||
| Other Study ID Numbers ICMJE | MUSC HR # 10870 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Medical University of South Carolina | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of South Carolina | ||||
| Verification Date | January 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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