DuraSorb® Mesh for Breast Reconstruction

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

168 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment DuraSorb® for breast reconstruction?

DuraSorb® is a type of mesh used to support soft tissues during breast reconstruction, and its design allows for easy handling and quick integration into the body. It is made from a material that gradually dissolves, providing support during healing without long-term complications. ^{1 2 3 4 5}

How is the treatment DuraSorb® Mesh unique for breast reconstruction?

DuraSorb® Mesh is unique because it is a bioabsorbable mesh made from polydioxanone (PDO), which provides temporary support to soft tissues during healing and is absorbed by the body over time, reducing the risk of long-term complications associated with permanent materials. ^{1 6 7 8 9}

Eligibility Criteria

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.

Is willing and able to return for all scheduled study visits

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.

I had a failed breast tissue expansion or implant in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Bioabsorbable Polydioxanone Mesh for Soft Tissue Reinforcement in Revisional Breast Surgery. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Biologic matrices in oncologic breast reconstruction after mastectomy. [2022]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Alloplastic adjuncts in breast reconstruction. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Current trends in postmastectomy breast reconstruction. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Use of Absorbable Mesh in Implant-Based Breast Reconstruction: A 7-Year Review. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Acellular dermal matrix and synthetic mesh in implant-based immediate breast reconstruction: Current concepts]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Early Clinical Outcomes of Polydioxanone Mesh for Prepectoral Prosthetic Breast Reconstruction. [2022]