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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01446627
Enrollment
300
Registered
2011-10-05
Start date
2010-01-31
Completion date
2012-12-31
Last updated
2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infection

Keywords

Absorbable vicryl subcuticular staples, metal staples, wound healing, cesarean section

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.

Interventions

None, no intervention made.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Cesarean sections * UT patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Wound infection/separationfrom time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Secondary

MeasureTime frame
wound hematomaFrom time of surgery up until wound assessed to be completely healed, no longer than 1 year.
wound seromaFrom time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026