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

February 2, 2017 updated by: University of Arkansas

Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1: Skin closure with suture
Subjects in this group will be randomized to suture for skin closure with computer generated random card draw.
Procedure: 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.
ACTIVE_COMPARATOR: Arm 2: Skin closure with staples
Subjects randomized to skin closure with staples with computer generated random card draw.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complication rates
Time Frame: 6 weeks postpartum

Wound complications will be classified as minor and major and the major complications will be further stratified as Seroma, Hematoma and Wound Infection/Surgical site infection (SSI).

  1. Minor wound disruption: any wound disruption that DOES not require that the incision be opened, evacuated, irrigated or debrided. There is no evidence of infection including erythema, induration or purulent material. No antibiotic therapy is given.

  2. Major wound disruption requires that incision be opened, evacuated, and or irrigated or debrided and includes:

    • Seroma: collection of serous fluid in the wound without evidence of infection
    • Hematoma: Demonstrable blood clot between the rectus fascia and the skin
    • Infection: Any wound that drains purulent material and shows at least 2 of the classic signs of infection; induration, erythema, tenderness, fever. Wound infections will be further classified as superficial or deep.
6 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 72 hours postpartum
To allow for adequate monitoring and assessment of postoperative pain, standardized postoperative pain analgesia protocol at our institution will be followed. This comprises of non-steroidal anti- inflammatory drugs and Narcotics as needed. Patients will be asked to complete a visual analog pain scale ranging from 0-10 on postoperative day 2. Information on use of pain medication during hospitalization and frequency will also be collected from the medical record.
72 hours postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Mary L Racher, MD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (ESTIMATE)

March 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 138350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe