Clinical Trials Directory

Trials / Completed

CompletedNCT01446627

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
The University of Texas Health Science Center, Houston · Academic / Other
Sex
Female
Age
14 Years – 50 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERThere is no intervention for this studyNone, no intervention made.

Timeline

Start date
2010-01-01
Primary completion
2012-01-01
Completion
2012-12-01
First posted
2011-10-05
Last updated
2013-05-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01446627. Inclusion in this directory is not an endorsement.