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Skin Closure Methods for Cesarean Section in Obese Women

N/A
Waitlist Available
Led By Jennifer McNulty, MD
Research Sponsored by MemorialCare Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of delivery
Awards & highlights

Study Summary

This trial will compare the two most common ways to close the skin after a c-section in obese women to see which is better.

Who is the study for?
This trial is for women over 18 years old with a BMI of at least 40 kg/m2 who are undergoing cesarean delivery. Participants must be able to return for a wound check within 7-14 days after leaving the hospital. Women with hypersensitivity to steri-strips, HIV/AIDS, current cancer treatment or history of radiation to the abdomen/pelvis, or active lupus flare cannot join.Check my eligibility
What is being tested?
The study aims to find out which skin closure method is better for Class III obese women having cesarean deliveries: using absorbable subcuticular sutures (stitches that dissolve) or stainless steel staples.See study design
What are the potential side effects?
Possible side effects include reactions at the site of closure such as pain, redness, swelling, infection and scarring. There may also be differences in healing times and cosmetic outcomes between the two methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Secondary outcome measures
Change in Hemoglobin (Pre-delivery and Post-delivery)
Neonatal Birthweight
Number of Participants According to Skin Incision
+10 more

Trial Design

2Treatment groups
Active Control
Group I: Stainless steel staplesActive Control1 Intervention
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Group II: Absorbable subcuticular SutureActive Control1 Intervention
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).

Find a Location

Who is running the clinical trial?

MemorialCare Health SystemLead Sponsor
19 Previous Clinical Trials
2,281 Total Patients Enrolled
2 Trials studying Obesity
120 Patients Enrolled for Obesity
University of California, IrvineOTHER
542 Previous Clinical Trials
1,921,763 Total Patients Enrolled
11 Trials studying Obesity
21,837 Patients Enrolled for Obesity
Jennifer McNulty, MDPrincipal InvestigatorMemoriaCare HealthSystem
3 Previous Clinical Trials
322 Total Patients Enrolled
2 Trials studying Obesity
120 Patients Enrolled for Obesity

Media Library

Stainless steel staples Clinical Trial Eligibility Overview. Trial Name: NCT02466776 — N/A
Obesity Research Study Groups: Stainless steel staples, Absorbable subcuticular Suture
Obesity Clinical Trial 2023: Stainless steel staples Highlights & Side Effects. Trial Name: NCT02466776 — N/A
Stainless steel staples 2023 Treatment Timeline for Medical Study. Trial Name: NCT02466776 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What demographic of individuals is most suitable to participate in this research?

"This study is recruiting 242 individuals with severe obesity aged 18-65. To meet the criteria, prospective patients must be: Female adults over eighteen years of age undergoing C-section delivery, have a BMI of at least 40 kg/m2 (as determined through height and weight reported during hospital admission), gestational period greater than 23 weeks, and willing to participate in follow up visual wound checks 7-14 days post hospital discharge."

Answered by AI

Is there a call for volunteers in this trial at the present time?

"As per the information on clinicaltrials.gov, this research project is not actively seeking out patients at this moment in time. Originally posted on May 1st 2015 and last updated June 4th 2015, while it may be dormant presently there are 110 other trials currently recruiting participants."

Answered by AI

Does this trial include participants who are older than 55?

"To be eligible for this medical intervention, individuals must fall between the age range of 18 and 65. For those under or over these ages, there are 6 trials targeting children and 80 studies dedicated to seniors respectively."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Other
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
University of California, Irvine
Long Beach Memorial Care Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

im 4 11 height i weigh 260 and its take control of health i need help please.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital: < 24 hours
Average response time
  • < 1 Day
~24 spots leftby Apr 2025