An interventional study of Acellular Dermal Matrix and Reconstruction without ADM in Breast Cancer and Breast Implant; Complications, Infection or Inflammation, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to female participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive ADM during their initial tissue expander placement.
Device: Acellular Dermal Matrix
Patients will not receive ADM during their initial tissue expander placement.
Procedure: Reconstruction without ADM
Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.
Safety - Major Complications
Relative rate of major complications (requiring unplanned re-admission or re-operation)
Time frame: 2 years
Effectiveness - BREASTQ
BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.
Time frame: 2 years
Secondary Effectiveness
Time from expander placement to implant exchange
Time frame: 2 years
Secondary Safety
Individual complication rates
Time frame: 2 years
Capsular Contracture
Rate of capsular contracture
Time frame: 2 years
Plan to share: 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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University of California, Los Angeles