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Tissue Adhesive
Skin Glue vs Sutures for Cesarean Section Closure
N/A
Recruiting
Led By Russell Miller, MD
Research Sponsored by Columbia University
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 intraoperative
Awards & highlights
Study Summary
This trial compares two methods of closing a Cesarean section incision to see which is better.
Who is the study for?
This trial is for women aged 18 or older who are scheduled for their first or subsequent cesarean deliveries, whether during labor or before it starts. They must be having a Pfannenstiel skin incision and giving birth to a live infant at the time of cesarean delivery.Check my eligibility
What is being tested?
The study compares two methods of closing incisions after cesarean sections: using Dermabond Prineo system versus standard subcuticular sutures (stitches under the skin). The goal is to see which method leads to better healing outcomes.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to adhesive in Dermabond Prineo, infection, pain at the incision site, poor wound healing, and scarring. Suture might cause discomfort, inflammation or also lead to infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient scar satisfaction
Secondary outcome measures
Incidence of surgical site infection (SSI)
Operative time
Skin closure time
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Dermabond Prineo GroupActive Control1 Intervention
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Group II: Suture GroupPlacebo Group1 Intervention
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,643 Total Patients Enrolled
Russell Miller, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a cesarean hysterectomy.I have had surgery with a vertical skin cut.I am a woman aged 18 or older.I had an emergency C-section without standard pre-op skin or vaginal prep.I am scheduled for a cesarean delivery, either my first or a repeat.I have had surgery with a Pfannenstiel incision.I cannot take standard pain medications after childbirth.
Research Study Groups:
This trial has the following groups:- Group 1: Dermabond Prineo Group
- Group 2: Suture Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for prospective participants in this investigation?
"According to information on clinicaltrials.gov, this research project is presently not recruiting patients; it was posted in June of 2023 and last updated a few days later. However, 65 other trials are actively seeking participants at the moment."
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