ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446627
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Jonathan P Faro, 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.

Condition or disease Intervention/treatment
Wound Infection Other: There is no intervention for this study

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 Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
metal staples Other: There is no intervention for this study
None, no intervention made.
Other Name: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.
Insorb vicryl staples Other: There is no intervention for this study
None, no intervention made.
Other Name: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.



Primary Outcome Measures :
  1. Wound infection/separation [ Time Frame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year. ]

Secondary Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing cesarean section who have their skin incision closed with staples.
Criteria

Inclusion Criteria:

  • Cesarean sections
  • UT patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446627


Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Jonathan P Faro, MD, PhD UTHSC at Houston

Responsible Party: Jonathan P Faro, Assistant Professor, ObGyn, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01446627     History of Changes
Other Study ID Numbers: HSC-GEN-11-0169
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Jonathan P Faro, The University of Texas Health Science Center, Houston:
Absorbable vicryl subcuticular staples
metal staples
wound healing
cesarean section

Additional relevant MeSH terms:
Wound Infection
Infection