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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlloDerm RTU | Active Comparator | Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. |
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| SurgiMend PRS | Active Comparator | Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlloDerm RTU | Device |
| ||
| SurgiMend PRS |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Shestak, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Center for Innovation in Restorative Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16106158 | Background | 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. | |
| 16374090 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AlloDerm RTU | Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU |
| FG001 | SurgiMend PRS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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.
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| 3 years following permanent implant placement. |
| 18948774 | 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. |
| 19055971 | 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. |
| 19568048 | 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. |
| 19644253 | Background | Namnoum JD. Expander/implant reconstruction with AlloDerm: recent experience. Plast Reconstr Surg. 2009 Aug;124(2):387-394. doi: 10.1097/PRS.0b013e3181aee95b. |
| 20011582 | 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. |
| 19952627 | 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. |
| 19952629 | 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. |
| 20124828 | 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. |
| 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) |
| 20395795 | 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. |
| 19644246 | 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. |
Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.
SurgiMend PRS
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AlloDerm RTU | Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU |
| BG001 | SurgiMend PRS | Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 3 years |
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| 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. | discrepancy is caused by funding ending and no data was collected from SurgiMend arm. | Posted | Mean | Full Range | units on a scale | 3 years following permanent implant placement. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AlloDerm RTU | Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU | 0 | 4 | 0 | 4 | ||
| EG001 | SurgiMend PRS | Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Shestak | University of Pittsburgh Plastic Surgery | 412-641-1487 | shestakkc@upmc.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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