INSORB: subcuticular stapling device for Operative Time

John Sealy Hospital at University of Texas Medical Branch, Galveston, TX
Operative Time+1 More ConditionsINSORB: subcuticular stapling device - Device
18 - 50
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Operative Time
  • Wound Healing

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Time of surgery through six weeks post partum

Start of surgery through end of skin closure
Operating time
Time of surgery through six weeks post partum
Adverse events
Composite wound complication
Patient satisfaction
Post operative pain
Use of resources
Wound cosmesis

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Suture wound closure
1 of 2
Absorbable staple wound closure
1 of 2

Active Control

Experimental Treatment

316 Total Participants · 2 Treatment Groups

Primary Treatment: INSORB: subcuticular stapling device · No Placebo Group · N/A

Absorbable staple wound closure
Experimental Group · 1 Intervention: INSORB: subcuticular stapling device · Intervention Types: Device
Suture wound closure
ActiveComparator Group · 1 Intervention: Subcuticular monocryl suture manufactured by Ethicon · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time of surgery through six weeks post partum

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
228 Previous Clinical Trials
54,690 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

Eligibility Criteria

Age 18 - 50 · Female Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many volunteers are participating in this clinical experiment?

"Affirmative. As per the records on, 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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. According to, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.