DuraSorb® Mesh for Breast Reconstruction

Not currently recruiting at 6 trial locations

Overseen By Joshua G Vose, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Surgical Innovation Associates, Inc.

Must not be taking: Non-NSAID anticoagulants, Immunosuppressants

Disqualifiers: Pregnancy, Failed expansion, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests DuraSorb® mesh to determine if it improves outcomes for breast reconstruction after mastectomy compared to past reconstructions without mesh. The goal is to assess whether this mesh can enhance the reconstruction process or increase safety. It targets women planning a two-step breast reconstruction immediately following mastectomy. Participants should not have infections at the surgery site or a history of radiation therapy to the chest area. As an unphased trial, this study allows participants to contribute to innovative research that could advance future breast reconstruction techniques.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as non-NSAID anti-coagulants and immunosuppressants, as they may increase the risk of complications. Please consult with the study team to discuss your specific medications.

What prior data suggests that DuraSorb® is safe for breast reconstruction?

Research has shown that DuraSorb® mesh is generally well-tolerated in breast reconstruction. A review of 31 studies involving over 2,400 patients found mostly positive results. In other studies, patients using DuraSorb® in complex breast surgeries reported high satisfaction and few complications.

Another study found that a similar material, polydioxanone mesh, had an acceptable rate of early complications in breast reconstruction. This suggests that DuraSorb® is likely safe for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care in breast reconstruction, which often involves permanent synthetic meshes or biologic materials, DuraSorb® Mesh is unique because it's a bioresorbable mesh. Researchers are excited about DuraSorb® because it provides temporary support to the reconstructed breast and gradually dissolves over time, potentially reducing complications related to long-term foreign material presence. This innovative feature could lead to better patient outcomes, making recovery smoother and more natural.

What evidence suggests that DuraSorb® Mesh is effective for breast reconstruction?

Studies have shown that DuraSorb® mesh effectively supports breast reconstruction by maintaining the shape of the breast implant. Research suggests that this mesh can lead to fewer complications and longer-lasting results. In one study, most patients experienced an increase in implant size and achieved good cosmetic results. Overall, the mesh appears to be a reliable option for enhancing breast reconstruction with a low risk of problems. Participants in this trial will receive DuraSorb® mesh, and outcomes will be compared to a historical control group. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman aged between 22 and 70.

I am scheduled for a mastectomy with immediate breast reconstruction in two stages.

Is able to understand the study requirements and is willing to provide written informed consent

Exclusion Criteria

Is pregnant or planning to become pregnant during study participation

I have had an infection that could affect my safety during breast reconstruction.

My doctor says my tissue isn't right for certain breast reconstruction right away.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the first stage of surgery and DuraSorb® implantation for breast reconstruction

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• DuraSorb®

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Group II: Historical Control Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

Surgical Innovation Associates, Inc.

Lead Sponsor

Trials

1

Recruited

170+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8963678/

Bioabsorbable Polydioxanone Mesh for Soft Tissue ... Durasorb PDO mesh appears to be efficacious as a breast implant pocket reinforcement in the reoperative setting with a low complication rate and durable results ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04646057

DuraSorb® in Prosthetic Breast Reconstruction This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh. Detailed Description.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825000993

A systematic review of mesh support of the breast in ... The use of mesh was associated with enhanced structural support, improved longevity of results and reduction in complications. However, the incorporation of ...

4. journals.lww.com journals.lww.com/prsgo/fulltext/2022/01000/early_clinical_outcomes_of_polydioxanone_mesh_for.54.aspx

Early Clinical Outcomes of Polydioxanone Mesh for... Polydioxanone mesh has an acceptable short-term complication rate in two-stage prepectoral prosthetic breast reconstruction.

5. academic.oup.com academic.oup.com/asj/article/43/3/NP155/6790098

A Safety Net for Complex Breast Implant Revision Surgery A total 89.4% of patients received an increase in implant volume (average change, +165.2 Cc); 87.5% of patients had favourable aesthetic outcomes, and 12.5% of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39763338/

Outcomes in Implant-Based Breast Reconstruction Utilizing ... This meta-analysis investigates the various biosynthetic options available as well as complications and outcomes.