DuraSorb® Mesh for Breast Reconstruction
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.12345Why 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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the first stage of surgery and DuraSorb® implantation for breast reconstruction
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Surgical Innovation Associates, Inc.
Lead Sponsor
Citations
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 ...
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.
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.aspxEarly Clinical Outcomes of Polydioxanone Mesh for...
Polydioxanone mesh has an acceptable short-term complication rate in two-stage prepectoral prosthetic breast reconstruction.
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 ...
Outcomes in Implant-Based Breast Reconstruction Utilizing ...
This meta-analysis investigates the various biosynthetic options available as well as complications and outcomes.
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