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Subcuticular Stapling Device

Absorbable Staples vs Sutures for Cesarean Wound Healing

N/A

Recruiting

Led By George Saade, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women ≥ 24 weeks viable gestation

18-50 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of surgery through six weeks post partum

Awards & highlights

Study Summary

This trial is testing whether or not subcuticular absorbable staples improve operative time and wound cosmetics in cesarean sections.

Who is the study for?

This trial is for women aged 18-50 who are at least 24 weeks pregnant and scheduled for a cesarean delivery. It's not suitable for those unwilling to consent, with coagulopathy, skin infections, minimal prenatal care, or requiring additional surgeries beyond cesarean.Check my eligibility

What is being tested?

The study compares two surgical techniques: subcuticular absorbable staples (INSORB) versus conventional sutures (monocryl) in cesarean deliveries. The goal is to see if INSORB can reduce operative time and improve wound appearance.See study design

What are the potential side effects?

Potential side effects may include issues related to wound healing such as infection, pain at the staple site, allergic reactions to materials used in either stapling or suturing, and differences in scar appearance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am pregnant and have reached at least 24 weeks of pregnancy.

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I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of surgery through end of skin closure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of surgery through end of skin closure

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of surgery through end of skin closure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Operating time

Secondary outcome measures

Adverse events

Composite wound complication

Patient satisfaction

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Absorbable staple wound closureExperimental Treatment1 Intervention

Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.

Group II: Suture wound closureActive Control1 Intervention

Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

241 Previous Clinical Trials

56,282 Total Patients Enrolled

Cooper CompaniesIndustry Sponsor

2 Previous Clinical Trials

40 Total Patients Enrolled

George Saade, MDPrincipal InvestigatorDivision Director/Co-PI

4 Previous Clinical Trials

16,930 Total Patients Enrolled

Media Library

INSORB (Subcuticular Stapling Device) Clinical Trial Eligibility Overview. Trial Name: NCT05112640 — N/A

Operative Time Research Study Groups: Suture wound closure, Absorbable staple wound closure

Operative Time Clinical Trial 2023: INSORB Highlights & Side Effects. Trial Name: NCT05112640 — N/A

INSORB (Subcuticular Stapling Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112640 — N/A

Frequently Asked Questions

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

How many volunteers are participating in this clinical experiment?

"Affirmative. As per the records on clinicaltrials.gov, this research project is actively enrolling participants. This medical experiment was introduced to the public on November 16th 2021 and recently revised on that same date; with 316 individuals needed for participation across 1 site."

Answered by AI

Are there any vacancies remaining for participants in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this trial is currently seeking out participants for recruitment. It was first made available on November 16th 2021 and has since been revised one time as of the same date; its target sample size being 316 from a single medical centre."

Answered by AI

Does this research accommodate elderly participants over 75 years old?

"This experiment is only open to adults aged 18 - 50. Concurrently, there are 7 trials specifically designed for minors and 37 studies dedicated to those over the age of 65."

Answered by AI

Who is eligible to be involved in this research initiative?

"To be eligible to participate in this scientific research, individuals must possess wound healing capabilities and meet the age requirements of 18-50. The total number of participants needed is 316."

Answered by AI

Recent research and studies

American Journal of Obstetrics and GynecologyJournal

A Randomized Study Comparing Skin Closure in Cesarean Sections: Staples Vs Subcuticular Sutures

Rousseau, Julie-Anne, Karine Girard, Lucile Turcot-Lemay, and Nancy Thomas. 2009. “A Randomized Study Comparing Skin Closure in Cesarean Sections: Staples Vs Subcuticular Sutures”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2009.01.019.

European Journal of Obstetrics & Gynecology and Reproductive BiologyJournal

Scar Appearance of Different Skin and Subcutaneous Tissue Closure Techniques in Caesarean Section: A Randomized Study

Gaertner, Isabell, Tilo Burkhardt, and Ernst Beinder. 2008. “Scar Appearance of Different Skin and Subcutaneous Tissue Closure Techniques in Caesarean Section: A Randomized Study”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2007.07.003.

European Journal of Obstetrics & Gynecology and Reproductive BiologyJournal

Incidence of Wound Complications in Cesarean Deliveries Following Closure with Absorbable Subcuticular Staples Versus Conventional Skin Closure Techniques

Schrufer-Poland, Tabitha L., Maria P. Ruiz, Samuel Kassar, Christopher Tomassian, Stacey D. Algren, and John D. Yeast. 2016. “Incidence of Wound Complications in Cesarean Deliveries Following Closure with Absorbable Subcuticular Staples Versus Conventional Skin Closure Techniques”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2016.07.501.

American Journal of Obstetrics and GynecologyJournal