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Completed

NCT Number: NCT01446627

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

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.

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Key information

Conditions

Wound Infection Infections

Age range

14 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cesarean sections
  • UT patients

Exclusion criteria

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

Treatment and study plan

There is no intervention for this study

Other

None, no intervention made.

Other names: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.

Primary outcomes

  1. Wound infection/separation

    Time frame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Secondary outcomes

  1. wound hematoma

    Time frame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.

  2. wound seroma

    Time frame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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