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FlexHD® Pliable for Implant-Based Breast Reconstruction

This study is looking at how well FlexHD® Pliable, a type of Acellular Dermal Matrix (a special tissue graft), works in women having immediate implant-based breast reconstruction after a mastectomy. We want to see how often major complications happen and if the reconstruction fails within 12 months. You might be able to join if you are a woman at least 22 years old, are having a mastectomy with immediate breast reconstruction using an implant, and can attend all study visits. The study is currently unclear on its recruitment status, but plans to enroll 259 participants.

Study design
This is a prospective, multi-center, single-arm study, meaning all 259 participants will receive the FlexHD® Pliable intervention. There is also a 'No intervention' historical control arm for comparison.
What's involved
You would need to attend all required study visits. The primary outcomes are measured at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to assess major complications and reconstructive failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797258

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Recruiting
NAAges 22+InterventionalTreatment
Musculoskeletal Transplant Foundation
~259 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:FlexHD® PliableNo intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of major complication
Measured over 12 months
+1 more outcome measured

Conditions

Implant Based Breast Reconstruction

Explore related trials

Mammoplasty

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Office
(817) 820-0000
Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Females at least 22 years of age
Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
Willing to provide Informed Consent
Able to return for all required study visits
Must read and understand English language

Exclusion

Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
Has a residual gross tumor at the intended reconstruction site
Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
Completed chemotherapy within 3 weeks prior to surgery
Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
Has a Body Mass Index (BMI) \>35
Has used nicotine products within 1 month of screening
Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study

What this trial measures

  • Frequency of major complication12 months

    Complications that require additional hospitalization or reoperation

  • Frequency of reconstructive failure12 months

    Removal/explantation of the breast implant