Post-Operative Cesarean Section Cosmesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pain Management After Cesarean Section - A Before-and-After Cohort Study

NCT06813638

Cesarean Section Cesarean Delivery Pain Management +6 more

COMPLETED

Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

NCT02279628

Postoperative Pain

UNKNOWN PHASE4

Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean

NCT02839005

Cesarean Section Sutures

COMPLETED NA

Knot Burial Technique for Rectus Sheath Closure

NCT04156282

Cesarean Section Complications

COMPLETED NA

Knotless Barbed Suture Closure of the Uterus at Caesarean Section

NCT06979687

Caesarean Section Caesarean Section; Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

trial comparing skin closure with absorbable subcuticular staples with subcuticular suture

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Scars will be digitally photographed by study staff and scored by 2 independent judges. The judges will be blinded to the closure method at time of scar evaluation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

subcuticular absorbable polyglycolic acid (INSORB) staples

Insorb absorbable staples are used for skin closure

Group Type ACTIVE_COMPARATOR

absorbable subcuticular polyglycolic acid staples (INSORB)

Intervention Type PROCEDURE

Insorb absorbable staples are used for skin closure

subcuticular absorbable polyglecaprone suture (Monocryl)

Monocryl absorbable staples are used for skin closure

Group Type ACTIVE_COMPARATOR

subcuticular, polyglecaprone suture (Monocryl)

Intervention Type PROCEDURE

Monocryl absorbable staples are used for skin closure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

absorbable subcuticular polyglycolic acid staples (INSORB)

Insorb absorbable staples are used for skin closure

Intervention Type PROCEDURE

subcuticular, polyglecaprone suture (Monocryl)

Monocryl absorbable staples are used for skin closure

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

INSORB Monocryl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-44
* Any race
* Any parity
* Scheduled cesarean section
* Neuraxial analgesia

Exclusion Criteria

* Non-English Speaking
* Incarcerated
* Maternal Connective Tissue Disorder
* Systemic maternal steroid use
* Three prior cesarean deliveries
* Body Mass Index (BMI) \>40

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes