Breast CancerNCT05190978
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
A study testing Acellular Dermal Matrix and Reconstruction without ADM in people with Breast Cancer and Breast Implant; Complications, Infection or Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. Read more about this study
- Who is it for?
- Ages 22 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Breast Implant; Complications, Infection or Inflammation
- What is being tested?
- Acellular Dermal Matrix and Reconstruction without ADM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
- Prophylactic and oncologic mastectomies are both acceptable
- Nipple sparing and skin sparing mastectomy techniques are both acceptable
Who cannot join
- Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
- Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
- Direct-to-implant reconstruction
- Pregnancy
- Delayed reconstruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jaco Festekjian, MD contact
United States1 site, 1 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Michael Delong, MD, 310 825 5510, mdelong@Mednet.ucla.edu
Jaco Festekjian, MD, 310 825 5510
About this study
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.
Read the detailed description
One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States.
Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019.
No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women's public health
- Being tested
- Acellular Dermal Matrix, Reconstruction without ADM
- Keywords
- breast cancer, breast reconstruction, breast implant
- Medical subject headings
- Breast Neoplasms, Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal MatrixDevice
Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
Reconstruction without ADMProcedure or surgery
Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.
| Study group | Role | What they receive |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Patients will receive ADM during their initial tissue expander placement. Receives: Device: Acellular Dermal Matrix |
| Control | Active comparator | Patients will not receive ADM during their initial tissue expander placement. Receives: Procedure: Reconstruction without ADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Major Complications
Relative rate of major complications (requiring unplanned re-admission or re-operation)
Measured: 2 years
Effectiveness - BREASTQ
BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.
Measured: 2 years
Secondary outcomes (3)
Secondary Effectiveness
Time from expander placement to implant exchange
Measured: 2 years
Secondary Safety
Individual complication rates
Measured: 2 years
Capsular Contracture
Rate of capsular contracture
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start20 Oct 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Yale University, University of California, Davis, University of Utah, University of California, San Francisco
- Responsible party
- Principal investigator, Michael R. Delong, University of California, Los Angeles
- Investigators
- Michael Delong, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190978
- Sponsor's protocol ID
- 190311
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All our results will be published in peer-reviewed journals in a timely manner for reference by physicians, manufacturers, regulatory agencies, and patients. As part of the study consent, subjects will be asked whether they agree to share their data in de-identified format with researchers. Data privacy and protection is a top priority. All data made available for public use will be de-identified, i.e., stripped of personally identifiable information (pii) and personal health information (phi) that could be used to deduce the identity of individual subjects, according to the HIPAA Privacy Rule, to comply with the NIH Privacy Rule and Research guidance
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
- ClinicalTrials.gov ID
- NCT05190978
- Acronym / sponsor ID
- 190311
- Keywords
- breast cancer, breast reconstruction, breast implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Yale University, University of California, Davis, University of Utah, University of California, San Francisco
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 13 Jan 2022 (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.
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.
Detailed description
One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States.
Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019.
No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women's public health
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Device: Acellular Dermal MatrixPatients will receive ADM during their initial tissue expander placement. |
| Control | Active comparator | Procedure: Reconstruction without ADMPatients will not receive ADM during their initial tissue expander placement. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
- Prophylactic and oncologic mastectomies are both acceptable
- Nipple sparing and skin sparing mastectomy techniques are both acceptable
Key exclusion criteria (5 listed)
- Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
- Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
- Direct-to-implant reconstruction
- Pregnancy
- Delayed 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 |
|---|---|---|
| Acellular Dermal MatrixAcellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort. | Device | Acellular Dermal Matrix |
| Reconstruction without ADMAcellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort. | Procedure or surgery | Control |
Primary outcome
Safety - Major Complications
Time frame: 2 years
Relative rate of major complications (requiring unplanned re-admission or re-operation)
Effectiveness - BREASTQ
Time frame: 2 years
BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.
3 secondary outcomes
Secondary Effectiveness
Time frame: 2 years
Secondary Safety
Time frame: 2 years
Capsular Contracture
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. All our results will be published in peer-reviewed journals in a timely manner for reference by physicians, manufacturers, regulatory agencies, and patients. As part of the study consent, subjects will be asked whether they agree to share their data in de-identified format with researchers. Data privacy and protection is a top priority. All data made available for public use will be de-identified, i.e., stripped of personally identifiable information (pii) and personal health information (phi) that could be used to deduce the identity of individual subjects, according to the HIPAA Privacy Rule, to comply with the NIH Privacy Rule and Research guidance
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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.
Jaco Festekjian, MD contact
Michael Delong, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix and Reconstruction without ADM in people with Breast Cancer and Breast Implant; Complications, Infection or Inflammation, run by University of California, Los Angeles at 1 site 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Delong, MD ((310) 825-5510, mdelong@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Major Complications (time frame: 2 years). 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 5 May 2026.