Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
NCT ID: NCT01781299
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
9 participants
INTERVENTIONAL
2012-09-30
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AlloDerm RTU
Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.
AlloDerm RTU
SurgiMend PRS
Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS
Interventions
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AlloDerm RTU
SurgiMend PRS
Eligibility Criteria
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Inclusion Criteria
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
2. Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product
3. Pregnancy
4. Bovine allergy
18 Years
FEMALE
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Ken Shestak
Principal Investigator
Principal Investigators
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Kenneth Shestak, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States
Countries
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References
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Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg. 2005 Sep;55(3):232-9. doi: 10.1097/01.sap.0000168527.52472.3c.
Gamboa-Bobadilla GM. Implant breast reconstruction using acellular dermal matrix. Ann Plast Surg. 2006 Jan;56(1):22-5. doi: 10.1097/01.sap.0000185460.31188.c1.
Topol BM, Dalton EF, Ponn T, Campbell CJ. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of the lower pole of the breast to reduce unwanted lift. Ann Plast Surg. 2008 Nov;61(5):494-9. doi: 10.1097/SAP.0b013e31816d82d9.
Maxwell GP, Gabriel A. Possible future development of implants and breast augmentation. Clin Plast Surg. 2009 Jan;36(1):167-72, viii. doi: 10.1016/j.cps.2008.08.005.
Stump A, Holton LH 3rd, Connor J, Harper JR, Slezak S, Silverman RP. The use of acellular dermal matrix to prevent capsule formation around implants in a primate model. Plast Reconstr Surg. 2009 Jul;124(1):82-91. doi: 10.1097/PRS.0b013e3181ab112d.
Namnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009 Aug;124(2):387-394. doi: 10.1097/PRS.0b013e3181aee95b.
Grabov-Nardini G, Haik J, Regev E, Winkler E. AlloDerm Sling for Correction of Synmastia After Immediate, Tissue Expander, Breast Reconstruction in Thin Women. Eplasty. 2009 Nov 12;9:e54.
Sbitany H, Sandeen SN, Amalfi AN, Davenport MS, Langstein HN. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009 Dec;124(6):1735-1740. doi: 10.1097/PRS.0b013e3181bf803d.
Nahabedian MY. AlloDerm performance in the setting of prosthetic breast surgery, infection, and irradiation. Plast Reconstr Surg. 2009 Dec;124(6):1743-1753. doi: 10.1097/PRS.0b013e3181bf8087.
Chun YS, Verma K, Rosen H, Lipsitz S, Morris D, Kenney P, Eriksson E. Implant-based breast reconstruction using acellular dermal matrix and the risk of postoperative complications. Plast Reconstr Surg. 2010 Feb;125(2):429-436. doi: 10.1097/PRS.0b013e3181c82d90.
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)
Lanier ST, Wang ED, Chen JJ, Arora BP, Katz SM, Gelfand MA, Khan SU, Dagum AB, Bui DT. The effect of acellular dermal matrix use on complication rates in tissue expander/implant breast reconstruction. Ann Plast Surg. 2010 May;64(5):674-8. doi: 10.1097/SAP.0b013e3181dba892.
Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
Other Identifiers
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PRO11020226
Identifier Type: -
Identifier Source: org_study_id
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