Acellular Dermal Matrix Investigation in Breast Reconstruction
Recruiting
N/AInterventional Study
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
467 (estimated)
Sponsor
RTI Surgical · Industry
Who this trial is looking for
This trial is looking for women who are having breast reconstruction surgery. Participants will receive a specific type of treatment during their surgery.
Are You a Good Fit for This Trial?
Must not be takingSystemic steroids
Rules you outBody mass index (BMI) > 35Uncontrolled diabetes
You may be able to join if
I am a genetic female
I am 22 years or older
I am having immediate breast reconstruction
I am having a two-stage breast reconstruction using pre-pectoral technique
I have had a nipple or skin-sparing mastectomy
I am willing and able to provide informed consent
I can comply with study requirements
You may not be able to join if
I am pregnant or breastfeeding
I am having other types of reconstruction at the same time
I have been told by the investigator that my tissue is unsuitable for the procedure
I have mental health issues that may interfere with the surgery
I have a serious medical condition that could affect my safety
I am currently in another clinical trial
I have an active infection in the area where reconstruction is planned
I smoke or use tobacco products
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Genetic female
* Age 22 or older at time of consent
* Undergoing immediate breast reconstruction
* 2 stage breast reconstruction using pre pectoral technique
* Nipple or skin sparing mastectomy
* Willing and capable of providing informed consent
* Able to comply with study req…
Inclusion Criteria:
* Genetic female
* Age 22 or older at time of consent
* Undergoing immediate breast reconstruction
* 2 stage breast reconstruction using pre pectoral technique
* Nipple or skin sparing mastectomy
* Willing and capable of providing informed consent
* Able to comply with study requirements
Exclusion Criteria:
* Planned concurrent reconstruction with pedicled flaps or free tissue
* Pregnant or breast feeding
* Investigator has determined tissue is unsuitable for two-stage breast reconstruction
* History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
* Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
* Vulnerable subject populations
* Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
* Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
* Active abscess or infection in the intended reconstruction site
* Residual gross tumor at the intended reconstruction site
* Active use of any tobacco/nicotine products
* Has body mass index (BMI) \>35
* Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
* Is currently taking medications including systemic steroids
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