Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section

Conditions
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Wound Infection

Intervention / Treatment
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* Other: There is no intervention for this study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cesarean sections UT patients Exclusion Criteria: Patients who have skin closed with suture, per attending choice.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metal staples<br> | Other: There is no intervention for this study<br>* None, no intervention made.<br>* Other names: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.;|
| Insorb vicryl staples<br> | Other: There is no intervention for this study<br>* None, no intervention made.<br>* Other names: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection/separation |  | from time of surgery up until wound assessed to be completely healed, no longer than 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound hematoma |  | From time of surgery up until wound assessed to be completely healed, no longer than 1 year. | 
| wound seroma |  | From time of surgery up until wound assessed to be completely healed, no longer than 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absorbable vicryl subcuticular staples, metal staples, wound healing, cesarean section