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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781299
• Other study ID #: PRO11020226
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Mastectomy

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)

Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg. 2005 Sep;55(3):232-9. — View Citation

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):429-36. doi: 10.1097/PRS.0b013e3181c82d90. — View Citation

Gamboa-Bobadilla GM. Implant breast reconstruction using acellular dermal matrix. Ann Plast Surg. 2006 Jan;56(1):22-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nahabedian MY. AlloDerm performance in the setting of prosthetic breast surgery, infection, and irradiation. Plast Reconstr Surg. 2009 Dec;124(6):1743-53. doi: 10.1097/PRS.0b013e3181bf8087. — View Citation

Namnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009 Aug;124(2):387-94. doi: 10.1097/PRS.0b013e3181aee95b. — View Citation

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):345-53. doi: 10.1097/PRS.0b013e3181aee807. — View Citation

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):1735-40. doi: 10.1097/PRS.0b013e3181bf803d. — View Citation

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

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. — View Citation

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. — View Citation

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)

* Note: There are 14 references in all — Click here to view all references

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.