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

Primary Purpose

Obesity, Severe, Cesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorbable subcuticular suture
Stainless steel staples
Sponsored by
MemorialCare Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Severe

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women > 18 years old undergoing cesarean delivery
  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

Sites / Locations

  • Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial HospitalRecruiting
  • Long Beach Memorial Care Center for Women at Miller Children's Hospital Long BeachRecruiting
  • Long Beach Memorial Care CenterRecruiting
  • University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stainless steel staples

Absorbable subcuticular Suture

Arm Description

Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.

Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.

Outcomes

Primary Outcome Measures

Composite Wound complication
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.

Secondary Outcome Measures

Patient satisfaction with wound healing
Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge.
Patient pain score
Patients' pain associated with their wound within 7-14 days after hospital discharge.

Full Information

First Posted
June 3, 2015
Last Updated
June 4, 2015
Sponsor
MemorialCare Health System
Collaborators
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT02466776
Brief Title
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Official Title
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MemorialCare Health System
Collaborators
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Severe, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stainless steel staples
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Arm Title
Absorbable subcuticular Suture
Arm Type
Active Comparator
Arm Description
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Intervention Type
Device
Intervention Name(s)
Absorbable subcuticular suture
Other Intervention Name(s)
3-0 monocryl
Intervention Description
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Intervention Type
Device
Intervention Name(s)
Stainless steel staples
Other Intervention Name(s)
Staples
Intervention Description
Patients will receive stainless steel staples for skin closure at time of cesarean section.
Primary Outcome Measure Information:
Title
Composite Wound complication
Description
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
Time Frame
Within 6 weeks postpartum
Secondary Outcome Measure Information:
Title
Patient satisfaction with wound healing
Description
Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge.
Time Frame
Within 2 weeks postpartum
Title
Patient pain score
Description
Patients' pain associated with their wound within 7-14 days after hospital discharge.
Time Frame
Within 2 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women > 18 years old undergoing cesarean delivery BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission Live gestation 23 weeks or greater Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.. Exclusion Criteria: Active lupus flare HIV/AIDS Current treatment for cancer or h/o radiation to the abdomen/pelvis Hypersensitivity to steri-strips
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer McNulty, MD
Phone
562-933-2730
Email
jmcnulty@memorialcare.org
First Name & Middle Initial & Last Name or Official Title & Degree
Deysi Caballero, LVN
Phone
562-933-2732
Email
dcaballero@mmeorialcare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer McNulty, MD
Organizational Affiliation
MemoriaCare HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McNulty, MD
Phone
562-933-2730
Email
jmcnulty@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Deysi Caballero, LVN
Phone
562-933-2732
Email
DCaballero@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Jennifer McNUlty, MD
First Name & Middle Initial & Last Name & Degree
Mary Zaki, MD
Facility Name
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McNulty, MD
Phone
562-933-2732
Email
jmcnulty@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Mary Zaki, MD
Phone
562-933-2730
Email
mnzaki@uci.edu
Facility Name
Long Beach Memorial Care Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McNulty, MD
Phone
562-933-2730
Email
jmcnulty@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Mary Zaki, MD
Phone
562-933-2730
Email
mnZaki@uci.edu
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McNulty, MD
Phone
562-933-2730
Email
jmcnulty@memorialcare.org
First Name & Middle Initial & Last Name & Degree
Mary Zali, MD
Phone
562-933-3730
Email
mnzaki@uci.edu

12. IPD Sharing Statement

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

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