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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446627
• Other study ID #: HSC-GEN-11-0169
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: May 2, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• Cesarean sections

• UT patients

Exclusion Criteria:

• Patients who have skin closed with suture, per attending choice.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Wound Infection

Intervention

Other:
• There is no intervention for this study
None, no intervention made.

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound infection/separation		from time of surgery up until wound assessed to be completely healed, no longer than 1 year.	No
Secondary	wound hematoma		From time of surgery up until wound assessed to be completely healed, no longer than 1 year.	No
Secondary	wound seroma		From time of surgery up until wound assessed to be completely healed, no longer than 1 year.	No