A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction (NCT05316324) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
United States353 participantsStarted 2022-03-23
Plain-language summary
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
Who can participate
Age range
21 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females aged 21-60 years
* Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
* Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
* Planning to undergo nipple-sparing or skin-sparing mastectomy
* Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
* Intraoperative confirmation of prepectoral plane viability by operating physician
Exclusion Criteria:
* History of radiotherapy to the operative breast
* Current smoker
* Non-English speaking patients
* Planning to undergo direct-to-implant reconstruction
* Prior sternotomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients who experience major complications