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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01477 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.
If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to receive Surgimend mesh or Alloderm mesh.
Breast Reconstruction Surgery:
All techniques of the breast reconstruction surgery are considered to be standard of care. You will be given a separate consent form to sign that explains the procedure and risks in more detail.
Data Collection:
Information about you will be collected, including your age, height, weight, breast size, past medical and smoking history, tumor size and location, and the surgical method used for the breast reconstruction surgery.
Information about the breast reconstruction surgery, such as what type of expanders are used, the surgical methods, and your recovery from the surgery will also be collected.
Follow-Up Visits:
About 1 week after the breast reconstruction surgery is complete, you will come in for a follow-up visit and the surgical team will check the surgery incision site and tissue used for the breast reconstruction surgery for any possible complications.
About 2 weeks after the breast reconstruction surgery, the expansion process will begin, as long as you do not have any complications that would prevent beginning the expansion process. During the expansion process, the surgeon will adjust the tissue expanders to stretch the area under the skin and muscle to make room for a breast implant(s).
After you begin the expansion process, you will return to the clinic 1 time each week for additional expansion until the desired size is reached. During each of the expansion process visits, you will be checked for any side effects, including fluid build up and infection.
After the expansion process is complete, you will return to the clinic 3 months later to receive your implant(s). About 1 to 12 months after you receive the implant(s), you will return to the clinic and 5 photographs will be taken to evaluate the appearance of the new implant(s). The photographs will be taken of the front, right and left sides of the implant(s) site and will be taken against a blue background. Your private areas will be covered (as much as possible). Your confidentiality will be protected at all times. You will not be identifiable personally from the discussion or presentation of the data. Unique study numbers will be assigned to the photographs.
Length of Study:
Your participation on this study will be over after you have received your permanent breast implant(s) and the photographs have been taken.
This is an investigational study.
Up to 398 patients will take part in this study. All will be enrolled at the MD Anderson main campus or one of the MD Anderson regional care centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alloderm Mesh | Experimental | Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant. |
|
| Surgimend Mesh | Experimental | Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture. |
|
| Control (no mesh) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alloderm | Device | 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complications After Tissue Expander Replacement With Implant | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W. Clemens, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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This study began enrollment on 04/15/2011 and was closed to enrollment on 12/08/2015. All recruitment done at the University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1- Surgimend | Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture. |
| FG001 | Arm 2-Alloderm | Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant. Device: Alloderm 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Surgimend |
| BG001 | Arm 2 | Alloderm |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Complications After Tissue Expander Replacement With Implant | Of the 90 randomized participants, 66 (74%) were evaluable for the primary measure | Posted | Number | participants | through study completion, an average of 1 year |
|
|
through study completion, an average of 1 year
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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 | Arm 1 | Surgimend | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | CTCAE v3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark W Clemens, Associate Professor, Plastic Surgery | UT MD Anderson Cancer Center | 713-794-1247 | mwclemens@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2014 | Sep 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Surgimend | Device | 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture. |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Total |
Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
|
| 31 |
| 3 |
| 31 |
| 8 |
| 31 |
| EG001 | Arm 2 | Alloderm | 0 | 35 | 2 | 35 | 18 | 35 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | CTCAE v3 | Systematic Assessment |
|
| Pain | General disorders | CTCAE v3 | Systematic Assessment |
|
| Delayed wound healing | Skin and subcutaneous tissue disorders | CTCAE v3 | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE v3 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v3 | Systematic Assessment |
|
| Pain | General disorders | CTCAE v3 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v3 | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE v3 | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE v3 | Systematic Assessment |
|
| Seroma | Vascular disorders | CTCAE v3 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE v3 | Systematic Assessment |
|
| Delayed wound healing | Skin and subcutaneous tissue disorders | CTCAE v3 | Systematic Assessment |
|
| Wound dehiscensence | Skin and subcutaneous tissue disorders | CTCAE v3 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |