Cesarean Trial of Staples vs. Sutures (CROSS)
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Details and patient eligibility
About
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
Full 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, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.
Enrollment
Sex
Volunteers
Inclusion criteria
- Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
746 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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