Breast ReconstructionNCT04646057
DuraSorb® in Prosthetic Breast Reconstruction
A study testing DuraSorb® in people with Breast Reconstruction, run by Surgical Innovation Associates, Inc. at 7 sites in United States.
Trial summary
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- DuraSorb®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Jan 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Harvard Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Northwestern Specialists Plastic Surgery
Chicago, Illinois, 60611
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
NorthShore University Health System
Evanston, Illinois, 60201
Kelsey-Seybold Clinic
Houston, Texas, 70725
University of Wisconsin Health University Hospital
Madison, Wisconsin, 53792
NYU Grossman School of Medicine
New York, New York, 10017
About this study
Official title: The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
Read the detailed description
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
- Breast Reconstruction
- Being tested
- DuraSorb®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraSorb®Device
Monofilament Surgical Mesh
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Device: DuraSorb® |
| Historical Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Success (CCS)
This outcome measure is a combination of effectiveness and safety components. CCS is defined as intraoperative fill volume of at least 45% of the total expander size and the absence of expander or implant removal for cause or major cosmetic revision between the DuraSorb Treatment Arm and historical controls.
Measured: 12 Month Follow-Up
Local Complications of Breast Reconstruction
The rates of a set of breast reconstruction complications (i.e. infection, serum, necrosis, etc.) will be measured between the DuraSorb Treatment Arm and historical controls.
Measured: 12 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start15 Jan 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surgical Innovation Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646057
- Sponsor's protocol ID
- 19-004
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04646057
- Acronym / sponsor ID
- 19-004
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Surgical Innovation Associates, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: DuraSorb® |
| Historical Control Arm | No intervention | – |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuraSorb®Monofilament Surgical Mesh | Device | Treatment Arm |
Primary outcome
Composite Clinical Success (CCS)
Time frame: 12 Month Follow-Up
This outcome measure is a combination of effectiveness and safety components. CCS is defined as intraoperative fill volume of at least 45% of the total expander size and the absence of expander or implant removal for cause or major cosmetic revision between the DuraSorb Treatment Arm and historical controls.
Local Complications of Breast Reconstruction
Time frame: 12 Month Follow-Up
The rates of a set of breast reconstruction complications (i.e. infection, serum, necrosis, etc.) will be measured between the DuraSorb Treatment Arm and historical controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuraSorb® in people with Breast Reconstruction, run by Surgical Innovation Associates, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical Success (CCS) (time frame: 12 Month Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.