259 Participants Needed

FlexHD® Pliable for Breast Reconstruction

(SHAPE Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Musculoskeletal Transplant Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment FlexHD® Pliable for breast reconstruction?

The study on FlexHD® Pliable showed successful breast reconstructions in 16 cases, with most patients experiencing good tissue integration. Complications were linked to patient health issues rather than the treatment itself, suggesting its effectiveness in challenging cases.12345

Is FlexHD® Pliable safe for use in breast reconstruction?

FlexHD® Pliable has been used in breast reconstruction, and while it shows successful outcomes, some studies report a higher risk of infection and the need for additional surgeries compared to not using it. Complications like infection and fluid buildup (seroma) have been noted, but these may be influenced by other health conditions of the patients.12456

What makes the treatment FlexHD® Pliable unique for breast reconstruction?

FlexHD® Pliable is a type of acellular dermal matrix (ADM) used in breast reconstruction that helps prevent muscle retraction and supports tissue growth, which can improve cosmetic outcomes. It is unique because it shows high rates of tissue incorporation, even in patients with significant health issues, although complications like infection and seroma can occur, often related to patient health rather than the ADM itself.12457

What is the purpose of this trial?

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique

Eligibility Criteria

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.
I am scheduled for a mastectomy with immediate implant reconstruction.
Willing to provide Informed Consent
See 2 more

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
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
FlexHD® Pliable

Find a Clinic Near You

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+

Findings from Research

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

References

Acellular Dermal Matrix-Associated Complications in Implant-Based Breast Reconstruction: A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Two Human Tissues. [2023]
Surgeon-Controlled Study and Meta-Analysis Comparing FlexHD and AlloDerm in Immediate Breast Reconstruction Outcomes. [2022]
AeroForm Tissue Expander: A Case of Early Accidental Inflation. [2021]
New Deep Dermal ADM Incorporates Well in Case Series of Complex Breast Reconstruction Patients. [2021]
Pre-hydrated sterile acellular dermal matrix allograft in breast reconstruction: review of a single unit's experience. [2019]
A Nationwide Analysis Evaluating the Safety of Using Acellular Dermal Matrix with Tissue Expander-Based Breast Reconstruction. [2022]
Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. [2022]
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