Cesarean Trial of Staples vs. Sutures

Completed · Not applicable

Conditions studied: Cesarean Section, Wound Complications, Patient Satisfaction, Pain Measurement

In brief

To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

Key facts

Study ID

NCT01211600

Run by

Thomas Jefferson University

People needed

746

Starts

2010-06-01

Expected to finish

2014-12-01

Last updated by the study team

2019-11-26

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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