What is the mechanism of action of this treatment?

Subcuticular absorbable staples improve operative time and wound cosmetics by providing efficient wound closure and potentially better aesthetic outcomes. These staples are absorbable, eliminating the need for removal and reducing follow-up visits. Their subcuticular placement minimizes scarring and promotes better healing, which is crucial for operative time patients as it leads to faster recovery, reduced infection risk, and improved patient satisfaction.

What side effects are associated with this type of intervention?

Subcuticular absorbable staples, used to improve operative time and wound cosmetics, are generally associated with fewer complications compared to traditional methods. Common side effects include a slight risk of infection, although this is typically lower than with conventional sutures. Healing times are often faster, and the aesthetic outcomes are usually better, with less scarring and improved wound appearance. Minor complications may include local irritation or mild erythema, which usually resolve quickly.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at improving operative time and wound cosmetics, particularly those that enhance wound closure efficiency and aesthetic outcomes. One such treatment is the use of subcuticular absorbable staples, which are designed to provide efficient wound closure and potentially better aesthetic results compared to conventional methods. These staples dissolve over time, reducing the need for removal and minimizing scarring. Other related FDA-approved treatments include advanced suturing materials and techniques, such as slowly-absorbable sutures, which have been shown to improve wound healing and cosmetic outcomes in surgical procedures.

What other types of research exist?

Promising novel alternatives to subcuticular absorbable staples for improving operative time and wound cosmetics include: 1) Barbed sutures, which eliminate the need for knot tying and distribute tension evenly along the wound, potentially reducing operative time and improving cosmetic outcomes. 2) Tissue adhesives like cyanoacrylate-based glues, which provide quick and effective wound closure with good cosmetic results. 3) Advanced wound closure devices such as zip-type skin closures, which offer precise approximation of wound edges and can be applied rapidly, enhancing both efficiency and aesthetic outcomes.

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Subcuticular Stapling Device

Absorbable Staples vs Sutures for Cesarean Wound Healing

N/A

Waitlist Available

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

Must not have

High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)

Current skin infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of surgery through six weeks post partum

Awards & highlights

Summary

This trial is testing a new method of closing wounds after cesarean sections using dissolvable staples placed under the skin. The trial will include women having cesarean deliveries, except those with certain infections or conditions. The new method aims to improve surgery time and wound appearance by using staples that dissolve on their own. Absorbable subcuticular staples have been found to be secure and effective in other surgical settings, such as renal transplant recipients.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am likely to have surgery beyond a cesarean, like hysterectomy or tubal ligation.

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I have a skin infection right now.

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I have chosen not to have my wound closed with stitches or mesh.

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I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of surgery through end of skin closure in minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of surgery through end of skin closure in minutes

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Operating Time

Secondary study objectives

Number of Adverse Events

Number of Participants With Composite Wound Complication

Post Operative Pain

+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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Subcuticular absorbable staples improve operative time and wound cosmetics by providing efficient wound closure and potentially better aesthetic outcomes. These staples are absorbable, eliminating the need for removal and reducing follow-up visits. Their subcuticular placement minimizes scarring and promotes better healing, which is crucial for operative time patients as it leads to faster recovery, reduced infection risk, and improved patient satisfaction.

Effects of thermal knives on wound healing.Novel low-cost approach to the treatment of ocular surface squamous neoplasia using pattern scanning laser photocoagulation.Technology Meets Tradition: CO2 Laser Circumcision versus Conventional Surgical Technique.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

249 Previous Clinical Trials

56,523 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

~31 spots leftby Sep 2025

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