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


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Mastectomy

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Complication Rates

Outcome Description:

To determine the overall complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products.

Outcome 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

Safety Issue:

No

Principal Investigator

Kenneth Shestak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

PRO11020226

NCT ID:

NCT01781299

Start Date:

September 2012

Completion Date:

September 2017

Related Keywords:

  • Breast Cancer
  • Mastectomy
  • Breast Cancer
  • Mastectomy
  • Immediate reconstruction
  • Breast Neoplasms

Name

Location
UPMC Center for Innovation in Restorative Medicine Pittsburgh, Pennsylvania  15213