FlexHD® Pliable for Breast Reconstruction

(SHAPE Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Musculoskeletal Transplant Foundation

Must not be taking: Oral corticosteroids

Disqualifiers: Pregnancy, Previous breast surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

259 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests FlexHD® Pliable, a material used in breast reconstruction surgery. The research focuses on women receiving immediate breast implants following a mastectomy, using a technique that places the implant on top of the chest muscle. Women planning to undergo this type of surgery and who can attend all study visits might be suitable candidates. The goal is to evaluate how well this material aids in healing and achieving a natural appearance after surgery. As an unphased trial, this study provides a unique opportunity to contribute to advancements in breast reconstruction techniques.

Do I have to stop taking my current medications for the trial?

The trial requires that you must not have taken oral corticosteroids for at least 1 month before the procedure and should not have a history of long-term use of these medications. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that FlexHD® Pliable is safe for breast reconstruction?

Research has shown that FlexHD® Pliable has been studied for use in breast reconstruction. Some studies have examined patient responses to the treatment. One study found that while FlexHD® Pliable is generally used safely, reports indicate more complications compared to other similar products. These complications can include infections or the need for additional surgeries.

The FDA reviewed FlexHD® and found it might have a higher risk of major issues compared to other similar treatments, potentially leading to serious problems. Anyone considering this treatment should discuss these risks with their doctor.

Overall, while FlexHD® Pliable is used in breast reconstruction, it carries some risks that require careful consideration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

FlexHD® Pliable is unique because it's a type of acellular dermal matrix (ADM) that offers a new approach for breast reconstruction. Unlike traditional options, such as silicone or saline implants, FlexHD® Pliable is derived from human tissue, which may integrate more naturally with a patient's own tissue. This could potentially lead to fewer complications and a more natural feel. Researchers are excited about this treatment as it may offer improved outcomes in terms of healing and long-term satisfaction for patients undergoing breast reconstruction.

What evidence suggests that FlexHD® Pliable is effective for breast reconstruction?

Research has shown that FlexHD® Pliable, the treatment under study in this trial, is effective for breast reconstruction. Studies have reported positive results in 16 cases, with most patients experiencing good integration of the material with their own tissue. This integration is important for achieving a natural look and feel. Additionally, FlexHD® Pliable has demonstrated low complication rates, making it a safe choice for implant-based breast reconstruction. Overall, the evidence supports its effectiveness and safety in these procedures. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for females at least 22 years old who are scheduled for immediate implant-based, prepectoral breast reconstruction after mastectomy. Participants must understand English and be able to attend all study visits. Those with previous breast surgeries (except biopsy), pregnant women, individuals with a BMI over 35, recent chemotherapy patients, or those who have used nicotine products within the last month cannot join.

Inclusion Criteria

I am a woman aged 22 or older.

Willing to provide Informed Consent

Able to return for all required study visits

Exclusion Criteria

I have had breast surgery, but not just a biopsy, at the site where the implant will be placed.

Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure

Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo immediate implant-based breast reconstruction using FlexHD® Pliable

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• FlexHD® Pliable

Trial Overview The SHAPE trial is examining the use of FlexHD® Pliable in females undergoing immediate pre-pectoral implant-based breast reconstruction. It's a prospective study across multiple centers where participants receive no additional intervention besides the standard surgical procedure using FlexHD® Pliable.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

FlexHD® Pliable

Who Is Running the Clinical Trial?

Musculoskeletal Transplant Foundation

Lead Sponsor

Trials

22

Recruited

1,800+

MCRA (an IQVIA business)

Collaborator

Trials

1

Recruited

260+

Bruder Consulting International, LLC

Collaborator

Trials

1

Recruited

260+

Published Research Related to This Trial

In a study of 547 breast reconstructions involving 382 women, there was no significant difference in postoperative complication rates between the two types of human acellular dermis (AlloDerm and FlexHD) used for immediate reconstruction.

However, multivariate analysis indicated that using FlexHD, along with factors like smoking and higher initial implant fill, may increase the risk of implant loss, suggesting careful consideration when choosing between these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Liu, DZ., Mathes, DW., Neligan, PC., et al.[2022]

In a multicenter randomized controlled trial involving 230 patients, there was no significant difference in matrix-related complications between the two commonly used human acellular dermal matrices, FlexHD Pliable and AlloDerm RTU, indicating both are safe options for implant-based breast reconstruction.

The study found that obesity and prepectoral placement of the matrix were associated with higher risks of complications, suggesting that patient factors should be considered when planning breast reconstruction procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular Dermal Matrix-Associated Complications in Implant-Based Breast Reconstruction: A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Two Human Tissues. Broyles, JM., Liao, EC., Kim, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4727694/

A Prospective Study Assessing Complication Rates and ... This is a prospective study to evaluate surgical and patient-reported outcomes using a deep dermal ADM, FlexHD Pliable. Surgical outcomes and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06797258

FlexHD® Pliable Investigation in Implant-Based Breast ... Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction. Conditions. Implant Based Breast Reconstruction.

3. mtfbiologics.org mtfbiologics.org/resources/news-press/2025/03/26/mtf-biologics-completes-first-implantation-of-flexhd--pliable-in-milestone-breast-reconstruction-clinical-trial

MTF Biologics Completes First Implantation of FlexHD® ... This milestone pivotal study (SHAPE) aims to evaluate the safety and effectiveness of FlexHD® Pliable in implant-based breast reconstruction procedures.

4. withpower.com withpower.com/trial/flexhd-pliable-for-breast-reconstruction-8fd81

FlexHD® Pliable for Breast Reconstruction (SHAPE Trial) The study on FlexHD® Pliable showed successful breast reconstructions in 16 cases, with most patients experiencing good tissue integration. Complications were ...

5. abs.amegroups.org abs.amegroups.org/article/view/6687/html

Acellular dermal matrices in breast reconstruction: a narrative ... Uniquely 'FlexHD Pliable' yields no sidedness. ... Surgeon-Controlled Study and Meta-Analysis Comparing FlexHD and AlloDerm in Immediate Breast Reconstruction ...

6. tga.gov.au tga.gov.au/news/safety-updates/acellular-dermal-matrix-products-used-breast-reconstruction

Acellular dermal matrix products used in breast ... The FDA's analysis suggested that two ADMs, FlexHD and Allomax, may have a higher risk profile than others. In particular, there were higher rates of major ...

7. journals.lww.com journals.lww.com/ijsprotocols/fulltext/9900/prepectoral_direct_to_implant_breast.53.aspx

Prepectoral direct-to-implant breast reconstruction using a . ... This retrospective cohort study includes all consecutive patients who underwent prepectoral DTI breast reconstruction with FlexHD Pliable PRE ...