DuraSorb® in Prosthetic Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2024-12-31

Brief Summary

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This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.

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Detailed Description

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Plastic surgeons have a variety of biologic and synthetic mesh available for use. However, no mesh has adequately evaluated safety and effectiveness for FDA approval or clearance for use in breast reconstruction. Therefore, no mesh is an appropriate comparator for a randomized clinical study.

This multi-center, prospective, clinical study with matched historical controls of total submuscular 2-stage breast reconstructions with no mesh will evaluate the safety and effectiveness of DuraSorb® monofilament surgical mesh when implanted in subjects undergoing 2-stage breast reconstruction.

Women scheduled for mastectomy and immediate 2-stage breast reconstruction will sign informed consent and satisfy eligibility criteria prior to the first stage of surgery and DuraSorb® implantation.

Maximum study follow-up is through one year after definitive reconstruction.

Conditions

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Breast Reconstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Group Type EXPERIMENTAL

DuraSorb®

Intervention Type DEVICE

Monofilament Surgical Mesh

Historical Control Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DuraSorb®

Monofilament Surgical Mesh

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

22 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No