NCT02466776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

June 3, 2015

Results QC Date

January 18, 2023

Last Update Submit

December 15, 2023

Conditions

Obesity, SevereCesarean Section

Outcome Measures

Primary Outcomes (1)

  • Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum

    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.

    At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum

Secondary Outcomes (13)

  • Number of Participants According to Skin Incision

    At time of surgery and hospitalization

  • Operating Surgeon Level

    At time of surgery

  • Surgical Assistant Level

    At time of surgery

  • Total Operative Time

    At time of surgery and hospitalization

  • Total Blood Loss

    At time of surgery

  • +8 more secondary outcomes

Study Arms (2)

Stainless steel staples

ACTIVE COMPARATOR

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

Device: Stainless steel staples

Absorbable subcuticular Suture

ACTIVE COMPARATOR

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

Device: Absorbable subcuticular suture

Interventions

Absorbable subcuticular sutureDEVICE

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

Also known as: 3-0 monocryl
Absorbable subcuticular Suture
Stainless steel staplesDEVICE

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

Also known as: Staples
Stainless steel staples

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women \> 18 years old undergoing cesarean delivery (CD)
  • 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.

You may not qualify if:

  • Active lupus flare
  • HIV/AIDS
  • Current treatment for cancer or h/o radiation to the abdomen/pelvis
  • Hypersensitivity to steri-strips

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital

Long Beach, California, 90806, United States

Location

Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Long Beach Memorial Care Center

Long Beach, California, 90806, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Sutures

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Dr. Mary Zaki
Organization
Kaiser Permanente
mary.nasry@gmail.com
503-332-2390

Study Officials

  • Jennifer McNulty, MD

    MemoriaCare HealthSystem

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maternal Fetal Medicine Specialist

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

January 9, 2024

Results First Posted

January 9, 2024

Record last verified: 2023-12

Locations

US(4)