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

NCT01781299 | Completed Phase 4 Results DMC

• 1 other identifier: PRO11020226
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Mastectomy

Keywords

Breast Cancer; Mastectomy; Immediate reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Aesthetic Evaluation

  3 years following permanent implant placement.

Study Arms (2)

AlloDerm RTU

ACTIVE COMPARATOR

Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.

Device: AlloDerm RTU

SurgiMend PRS

ACTIVE COMPARATOR

Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.

Device: SurgiMend PRS

Interventions

AlloDerm RTU DEVICE

AlloDerm RTU

SurgiMend PRS DEVICE

SurgiMend PRS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's with ability to provide informed consent.
• Subjects greater than 18 years old
• Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and
• 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.

You may not qualify if:

• Subjects less than 18 years of age
• Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product
• Pregnancy
• Bovine allergy

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Center for Innovation in Restorative Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (14)

• 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.

  PMID: 16106158 BACKGROUND

• 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.

  PMID: 16374090 BACKGROUND

• 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.

  PMID: 18948774 BACKGROUND

• 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.

  PMID: 19055971 BACKGROUND

• 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.

  PMID: 19568048 BACKGROUND

• Namnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009 Aug;124(2):387-394. doi: 10.1097/PRS.0b013e3181aee95b.

  PMID: 19644253 BACKGROUND

• 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.

  PMID: 20011582 BACKGROUND

• 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.

  PMID: 19952627 BACKGROUND

• 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.

  PMID: 19952629 BACKGROUND

• 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.

  PMID: 20124828 BACKGROUND

• Shatkin BT "A new option for implant-based breast reconstruction using SurgiMend PRS® (sterile, acellular bovine fetal dermis)" (in submission)

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 20395795 BACKGROUND

• 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.

  PMID: 19644246 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Kenneth Shestak
• Organization: University of Pittsburgh Plastic Surgery

shestakkc@upmc.edu

412-641-1487

Study Officials

• Kenneth Shestak, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 31, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-05

Locations

US (1)