What is the mechanism of action of this treatment?

Mesh-based breast reconstruction treatments work by providing structural support to the reconstructed breast using synthetic or biological mesh materials. These meshes act as scaffolds that reinforce the tissue and support the implant or tissue flap, promoting tissue integration and stability. This mechanism is crucial for achieving a natural breast shape and reducing complications such as implant displacement or capsular contracture. For patients, understanding these benefits is important as it can lead to better aesthetic outcomes and fewer postoperative issues.

What side effects are associated with this type of intervention?

Common side effects of breast reconstruction, including mesh-based procedures, involve infection, bleeding, pain, and scarring. Specific to mesh-based reconstructions, patients may experience mesh infection, mesh extrusion, chronic pain, seroma (fluid accumulation), and delayed wound healing.

What prior FDA approvals exist?

FDA approvals for breast reconstruction treatments have included various implants and tissue expanders designed to provide structural support. These devices are often used in conjunction with autologous tissue reconstruction or as standalone solutions. While specific mesh-based products for breast reconstruction are not detailed in the provided context, the use of mesh in surgical procedures is generally aimed at providing additional support and improving outcomes. For instance, acellular dermal matrices (ADMs) are commonly used in breast reconstruction to support implants and improve contour and projection.

What other types of research exist?

One promising novel alternative to mesh-based breast reconstruction is the use of resorbable synthetic meshes, such as poly-4-hydroxybutyrate (P4HB) mesh. These meshes provide the necessary structural support while gradually being absorbed by the body, potentially reducing long-term complications associated with permanent synthetic meshes. Another alternative is the use of biological meshes, such as acellular dermal matrices (ADMs), which are derived from human or animal tissues and support tissue integration and healing. Both options have shown positive outcomes in terms of safety and efficacy in recent studies.

← Back to Search

Mesh Implant

DuraSorb® Mesh for Breast Reconstruction

N/A

Waitlist Available

Research Sponsored by Surgical Innovation Associates, Inc.

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 12 month follow-up

Awards & highlights

Study Summary

This trial compares outcomes of breast reconstructions that use mesh to support the implants to those that don't use mesh.

Who is the study for?

This trial is for women aged 22-70 planning to have breast reconstruction with a mesh after mastectomy. They must be able to attend all visits, understand the study, and consent. Exclusions include prior failed reconstructions or radiation at the site, extreme BMI values, certain medications, recent nicotine use, pregnancy plans during the study, and any health issues that increase surgery risks.Check my eligibility

What is being tested?

The trial is testing DuraSorb®, a type of surgical mesh used in breast reconstruction post-mastectomy. It compares outcomes like safety and effectiveness between patients receiving this new mesh versus those who had similar surgeries without it.See study design

What are the potential side effects?

While specific side effects are not listed here, surgical meshes can typically cause complications such as infection at the surgery site, pain or discomfort around the area where they're implanted, possible allergic reactions or rejection by body tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite Clinical Success (CCS)

Local Complications of Breast Reconstruction

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

Group II: Historical Control ArmActive Control1 Intervention

Do I qualify?Apply below to find out

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

Mesh-based breast reconstruction treatments work by providing structural support to the reconstructed breast using synthetic or biological mesh materials. These meshes act as scaffolds that reinforce the tissue and support the implant or tissue flap, promoting tissue integration and stability. This mechanism is crucial for achieving a natural breast shape and reducing complications such as implant displacement or capsular contracture. For patients, understanding these benefits is important as it can lead to better aesthetic outcomes and fewer postoperative issues.

Find a Location

Who is running the clinical trial?

Surgical Innovation Associates, Inc.Lead Sponsor

Media Library

DuraSorb® (Mesh Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04646057 — N/A

Breast Reconstruction Research Study Groups: Treatment Arm, Historical Control Arm

Breast Reconstruction Clinical Trial 2023: DuraSorb® Highlights & Side Effects. Trial Name: NCT04646057 — N/A

DuraSorb® (Mesh Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646057 — N/A

~39 spots leftby Jun 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.