RECRUITING

Acellular Dermal Matrix Investigation in Breast Reconstruction

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Conditions

Breast Reconstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Official Title

Acellular Dermal Matrix Investigation in Breast Reconstruction

Quick Facts

Study Start:2024-11-22
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06456554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Genetic female
  2. * Age 22 at time of consent
  3. * Undergoing immediate breast reconstruction
  4. * 2 stage breast reconstruction using pre pectoral technique
  5. * Nipple or skin sparing mastectomy
  6. * Willing and capable of providing informed consent
  7. * Able to comply with study requirements
  1. * Planned concurrent reconstruction with pedicled flaps or free tissue
  2. * Pregnant or breast feeding
  3. * Investigator has determined tissue is unsuitable for two-stage breast reconstruction
  4. * History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
  5. * 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
  6. * Vulnerable subject populations
  7. * 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
  8. * Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
  9. * Active abscess or infection in the intended reconstruction site
  10. * Residual gross tumor at the intended reconstruction site
  11. * Active use of any tobacco/nicotine products
  12. * Has body mass index (BMI) \>35
  13. * Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
  14. * Is currently taking medications including systemic steroids
  15. * Is scheduled to undergo post-operative radiation therapy

Contacts and Locations

Study Contact

Leah Johnson
CONTACT
952-393-2831
leah.johnson@brightresearch.com
Jennifer Johnson
CONTACT
jljohnson@rtix.com

Study Locations (Sites)

Washington University
Saint Louis, Missouri, 63110
United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: RTI Surgical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Reconstruction