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

Completed

• Conditions: Wound Infection
• Interventions: Other: There is no intervention for this study

• Registration Number: NCT01446627
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Primary Completion: 2012-01
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Cesarean sections
• UT patients

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metal staples	There is no intervention for this study	-
Insorb vicryl staples	There is no intervention for this study	-

Primary Outcome Measures

Name	Time	Method
Wound infection/separation	from time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States