Acellular Dermal Matrix for Breast Reconstruction

Acellular Dermal Matrix Investigation in Breast Reconstruction

Recruiting N/A Interventional 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 taking Systemic steroids
Rules you out Body 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.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

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…
Contacts

Ana Villagomez

202-552-6013

avillagomez@mcra.com

CONTACT

Paul Bonvallet, PhD

pbonvallet@evergenbio.com

CONTACT