Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery

MemorialCare Health System

Status: Completed

Conditions: Cesarean Section; Obesity, Severe

Treatments: Device: Stainless steel staples; Device: Absorbable subcuticular suture

Study type: Interventional

Funder types: Other

Identifiers

NCT02466776

459-14

Details and patient eligibility

About

The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.

Full description

A. To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).

B. No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).

C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.

Enrollment: 238 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women > 18 years old undergoing cesarean delivery (CD)
2. BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
3. Live gestation 23 weeks or greater
4. Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.

Exclusion criteria

1. Active lupus flare
2. HIV/AIDS
3. Current treatment for cancer or h/o radiation to the abdomen/pelvis
4. Hypersensitivity to steri-strips

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Stainless steel staples

Active Comparator group

Description:

Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).

Treatment:

Device: Stainless steel staples

Absorbable subcuticular Suture

Active Comparator group

Description:

Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).

Treatment:

Device: Absorbable subcuticular suture