Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section
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| First Received Date ICMJE | September 30, 2011 | ||||
| Last Updated Date | May 2, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Wound infection/separation [ Time Frame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01446627 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section | ||||
| Official Title ICMJE | Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section | ||||
| Brief Summary | The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis. |
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| Detailed Description | Procedures: A list will be compiled of patients who underwent cesarean section at Memorial Hermann Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT patients who had their skin closed with Insorb or metal staples will be included in this list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. Any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. Additional notes will be made of any co-morbid conditions, including, but not limited to, >30 BMI, chronic hypertension, diabetes mellitus, HIV, history of tobacco use. Once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. In addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by Fisher's exact test, to determine statistical significance. Course of Study: Data will be obtained from UT patients who underwent cesarean section from January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb or metal staples will be included in analysis. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Women undergoing cesarean section who have their skin incision closed with staples. |
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| Condition ICMJE | Wound Infection | ||||
| Intervention ICMJE | Other: There is no intervention for this study
None, no intervention made.
Other Name: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made. |
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| Study Group/Cohort (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 | 300 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 14 Years to 50 Years | ||||
| 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 | NCT01446627 | ||||
| Other Study ID Numbers ICMJE | HSC-GEN-11-0169 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jonathan P Faro, The University of Texas Health Science Center, Houston | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||
| Verification Date | May 2013 | ||||
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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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