Clinical trial NCT01446627: Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section
Official title: Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Infection
Keywords: Absorbable vicryl subcuticular staples
metal staples
wound healing
cesarean section
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing cesarean section who have their skin incision closed with staples.

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.

Eligibility criteria: Inclusion Criteria:

* Cesarean sections
* UT patients

Exclusion Criteria:

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

Primary outcomes:
measure: Wound infection/separation
timeFrame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.
Secondary outcomes:
measure: wound hematoma
timeFrame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
measure: wound seroma
timeFrame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: UTHSC at Houston
name: Jonathan P Faro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: