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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Severe Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stainless steel staples

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

Group Type ACTIVE_COMPARATOR

Stainless steel staples

Intervention Type DEVICE

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

Absorbable subcuticular Suture

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

Group Type ACTIVE_COMPARATOR

Absorbable subcuticular suture

Intervention Type DEVICE

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

Interventions

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Absorbable subcuticular suture

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

Intervention Type DEVICE

Stainless steel staples

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

Intervention Type DEVICE

Other Intervention Names

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3-0 monocryl Staples

Eligibility Criteria

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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.