FlexHD® Pliable for Breast Reconstruction
(SHAPE Trial)
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo immediate implant-based breast reconstruction using FlexHD® Pliable
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- FlexHD® Pliable
Find a Clinic Near You
Who Is Running the Clinical Trial?
Musculoskeletal Transplant Foundation
Lead Sponsor
MCRA (an IQVIA business)
Collaborator
Bruder Consulting International, LLC
Collaborator