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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
No Placebo-Only Group
Summary
This trial tests a special surgical mesh called DuraSorb® in women having breast reconstruction after mastectomy. The mesh helps support the new breast shape as it heals. The study will compare results with past surgeries that did not use any mesh. DuraSorb is designed for soft tissue reinforcement, known for its ease of handling and rapid tissue incorporation.
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Clinical Success (CCS)
Local Complications of Breast Reconstruction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Group II: Historical Control ArmActive Control1 Intervention
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.
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Who is running the clinical trial?
Surgical Innovation Associates, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged between 22 and 70.I have had an infection that could affect my safety during breast reconstruction.I had a failed breast tissue expansion or implant in the past.I still have visible tumor at the site planned for surgery.I have had radiation therapy on my chest or where my surgery was.My doctor says my tissue isn't right for certain breast reconstruction right away.I am on medication that could affect breast surgery recovery.I will have radiation therapy at the surgery site after my operation.I am scheduled for a mastectomy with immediate breast reconstruction in two stages.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Historical Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.