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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01781299
Other study ID # PRO11020226
Secondary ID
Status Completed
Phase Phase 4
First received January 24, 2013
Last updated May 10, 2017
Start date September 2012
Est. completion date September 2015

Study information

Verified date May 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
AlloDerm RTU

SurgiMend PRS


Locations

Country Name City State
United States UPMC Center for Innovation in Restorative Medicine Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (14)

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Outcome

Type Measure Description Time frame Safety issue
Primary Complication Rates 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. 3 years
Secondary Aesthetic Evaluation 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. 3 years following permanent implant placement.
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