DuraSorb® in Prosthetic Breast Reconstruction
Status unconfirmed · Not applicable
Conditions studied: Breast Reconstruction
In brief
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
Key facts
- Study ID
- NCT04646057
- Run by
- Surgical Innovation Associates, Inc.
- People needed
- 168
- Starts
- 2021-01-15
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-04-18
Who can join
Age: 22 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female between the inclusive ages of 22 and 70 at the time of initial expander surgery
- Scheduled to undergo either unilateral or bilateral mastectomy with immediate 2-stage breast reconstruction
- Is able to understand the study requirements and is willing to provide written informed consent
- Is willing and able to return for all scheduled study visits
You may not qualify if…
- Is pregnant or planning to become pregnant during study participation
- Has a history of failed tissue expansion or breast implantation at the intended reconstruction site
- has a residual gross tumor at the intended reconstruction site
- has been treated for a systemic infection or a local infection at the surgical site that the investigator determines will affect the safety of the subject during breast reconstruction and/or mesh use
- has, as determined by the investigator, unsuitable tissue integrity for immediate 2-stage breast reconstruction
- has undergone previous radiation therapy to the reconstruction site or chest wall
- is scheduled to undergo post-operative radiation therapy at the reconstruction site
- has a Body Mass Index (BMI) < 14 or > 44
- has used nicotine products within 90 days of screening
- is currently taking medications including non-NSAID anti-coagulants, immunosuppressants (including systemic steroids), or other medications determined by the investigator to place the subject at an increased risk of local complications of breast reconstruction
- has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
- has participated in any other clinical study that the investigator feels may interfere with this clinical study
Where it is running
- Northwestern Specialists Plastic Surgery — Chicago, Illinois, United States
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- NorthShore University Health System — Evanston, Illinois, United States
- Harvard Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States
- NYU Grossman School of Medicine — New York, New York, United States
- Kelsey-Seybold Clinic — Houston, Texas, United States
- University of Wisconsin Health University Hospital — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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