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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ken Shestak, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01781299
First received: January 24, 2013
Last updated: May 10, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Intervention Model Description:
We are looking at 2 products called Acellular Dermal Matrix (ADM) implant to evaluate the outcomes of 2 specific ADM products: SurgiMend PRS and AlloDerm RTU.
Masking: Participant
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 Ken Shestak, University of Pittsburgh:

Primary Outcome Measures:
  • Complication Rates [ Time Frame: 3 years ]
    To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: 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.


Secondary Outcome Measures:
  • Aesthetic Evaluation [ Time Frame: 3 years following permanent implant placement. ]
    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. Breast-Q examination is on a scale of 25-100 with 25 questions on a scale of 1-4 where 1 is very dissatisfied and 4 is very satisfied.


Enrollment: 9
Study Start Date: September 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781299

Locations
United States, Pennsylvania
UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Kenneth Shestak, MD University of Pittsburgh
  More Information

Publications:
Shatkin BT "A new option for implant-based breast reconstruction using SurgiMend PRS® (sterile, acellular bovine fetal dermis)" (in submission)
Vinas, LA, Corbitt, JD, Anthony, L and Greenburg, AG "Fetal bovine acellular dermal matrix (SurgiMend PRS®) in one-stage immediate prosthetic breast reconstruction" (in submission)

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
Results First Received: January 27, 2017
Last Updated: May 10, 2017

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

ClinicalTrials.gov processed this record on July 24, 2017