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

NCT ID: NCT01820221

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm 1: Skin closure with suture

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Random card draw to either suture skin closure or staple skin closure arm of study.

Arm 2: Skin closure with staples

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Random card draw to either suture skin closure or staple skin closure arm of study.

Interventions

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

Random card draw to either suture skin closure or staple skin closure arm of study.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary L Racher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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138350

Identifier Type: -

Identifier Source: org_study_id

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