Status:
COMPLETED
Cesarean Trial of Staples vs. Sutures
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Main Line Health
Conditions:
Cesarean Section
Wound Complications
Eligibility:
FEMALE
Phase:
NA
Brief Summary
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
Detailed Description
Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, inclu...
Eligibility Criteria
Inclusion
- Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.
Exclusion
- Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels \> 95 and 120 respectively within the week prior to delivery),
- Vertical skin incisions
- Chronic steroid use
- Active lupus flare
- HIV/AIDS
- Current treatment for cancer or a history of radiation to the abdomen/pelvis
- Current treatment with immunosuppressant medications secondary to history of transplantation
- Emergency cesarean(precluding informed consent prior to surgery)
- Lack of access to a phone
- Allergy to suture or staple material
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
746 Patients enrolled
Trial Details
Trial ID
NCT01211600
Start Date
June 1 2010
End Date
December 1 2014
Last Update
November 26 2019
Active Locations (2)
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1
Yale University
New Haven, Connecticut, United States
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107