Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU

This study is currently recruiting participants.
Verified June 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Ken Shestak, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01781299
First received: January 24, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.


Condition Intervention Phase
Breast Cancer
Mastectomy
Device: AlloDerm RTU
Device: SurgiMend PRS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Complication Rates [ Time Frame: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years ] [ Designated as safety issue: No ]
    To determine the overall complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products.

  • Economic Evaluation [ Time Frame: End of Study Participation ] [ Designated as safety issue: No ]
    At the completion of the Aesthetic Evaluation records will be evaluated to ascertain the overall cost of ADMs used.


Secondary Outcome Measures:
  • Aesthetic Evaluation [ Time Frame: 6 weeks, 1 year, and 3 years following permanent implant placement. ] [ Designated as safety issue: No ]
    Initial aesthetic evaluation will occur at approximately 6 weeks after permanent implant placement. Re-evaluation will occur at 1 and 3 years following permanent implant placement. This will involve physical examination, 2D photographs, and patient Breast-Q self-examination.


Other Outcome Measures:
  • ADM Biopsy [ Time Frame: Approximately 12 weeks after ADM implantation (at time of second operative procedure) ] [ Designated as safety issue: No ]
    Biopsies are taken at time of permanent implant placement. A semi-quantitative scoring system will be used to evaluate histological characteristics, such as capsule formation, inflammation, presence of polymorphonuclear cells, giant cells, plasma cells and/or degradation of material.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AlloDerm RTU
Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
Device: AlloDerm RTU
Active Comparator: SurgiMend PRS
Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
Device: SurgiMend PRS

Detailed Description:

In recent years, acellular dermal matrix (ADM) products have increasingly been utilized in breast reconstruction in order to protect the implant from exposure under a thin mastectomy skin flap while also allowing better control of the inframammary fold and, therefore, a better cosmetic result. In current clinical practice, cost is a factor in considering procedures and adjunct products. AlloDerm RTU and SurgiMend PRS are dissimilar in cost, with AlloDerm RTU more costly by 30-50%, and it is unclear if they are similar in efficacy.

This study will be a prospective, randomized-to-test article (ADM), controlled, blinded-to-aesthetic/biopsy specimen evaluator trial. It will provide a way to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS product as well as the relative economics of these two treatment options. Study subjects will only be randomized to one of two surgical mesh products. Patient information including age, BMI, smoking history, tumor size and location, preoperative bra cup size, mastectomy specimen weight, mastectomy method, plastic surgeon, mastectomy surgeon, quality of skin, tissue expander type and maximal volume, intra-operative fill volume, gel/saline implant type and size, chemotherapy, and radiation therapy will be summarized.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject's with ability to provide informed consent.
  2. Subjects greater than 18 years old
  3. Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and
  4. Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits.

Exclusion Criteria:

  1. Subjects less than 18 years of age
  2. Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product
  3. Pregnancy
  4. Bovine allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781299

Contacts
Contact: Peter W Adams, BS 412-864-2582 adamsp3@upmc.edu

Locations
United States, Pennsylvania
UPMC Center for Innovation in Restorative Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sub-Investigator: Peter W Adams, BS         
Sub-Investigator: Paul Afrooz, MD         
Sub-Investigator: Autumn Aul, PA-C         
Sub-Investigator: Jacqueline Bliley         
Sub-Investigator: Spencer Brown, PhD         
Sub-Investigator: Carolyn De La Cruz, MD         
Sub-Investigator: Michael Gimbel, MD         
Sub-Investigator: Carlynn Graves, BS, CCRC         
Sub-Investigator: Russell Kling         
Sub-Investigator: Kacey Marra, PhD         
Sub-Investigator: Louise Martin, RN, BSN, CCRC         
Sub-Investigator: Nancy McCormick, MS, CCRC         
Sub-Investigator: Jenelle Mock, RN, BSN         
Sub-Investigator: Vu Nguyen, MD         
Sub-Investigator: J. Peter Rubin, MD         
Sub-Investigator: Patsy Simon, RN, BS, CCRC         
Sub-Investigator: Kelly Snyder, PA-C         
Sub-Investigator: Wendy Wakefield, CRNP         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Kenneth Shestak, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: Ken Shestak, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01781299     History of Changes
Other Study ID Numbers: PRO11020226
Study First Received: January 24, 2013
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Breast Cancer
Mastectomy
Immediate reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014