Sutures vs. Staples Skin Closure After C-section in Obese Patients

University of Arkansas

Status: Terminated

Conditions: Obesity; Pregnancy

Treatments: Procedure: Suture vs. staples closure method after c-section in obese women.

Study type: Interventional

Funder types: Other

Identifiers

NCT01820221

138350

Details and patient eligibility

About

This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.

Enrollment: 148 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• BMI ≥ 30kg/m2 on admission to labor and delivery
• Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery
• Singleton pregnancies
• Gestational age ≥ 24weeks
• Cesarean delivery performed under regional anesthesia

Exclusion criteria

• Refusal to participate
• BMI < 30kg/m2
• < 24 weeks gestation
• Intrauterine fetal demise
• Chronic pain syndrome requiring chronic narcotic use
• Emergent clinical situations which preclude obtaining informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Arm 1: Skin closure with suture

Active Comparator group

Description:

Subjects in this group will be randomized to suture for skin closure with computer generated random card draw.

Treatment:

Procedure: Suture vs. staples closure method after c-section in obese women.

Arm 2: Skin closure with staples

Active Comparator group

Description:

Subjects randomized to skin closure with staples with computer generated random card draw.

Treatment:

Procedure: Suture vs. staples closure method after c-section in obese women.