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| ID | Type | Description | Link |
|---|---|---|---|
| 070415 |
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This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.
The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Method | Active Comparator | Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander |
|
| Dermamatrix Arm | Experimental | Arm which uses Dermamatrix as the lateral expander coverage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermamatrix to cover lateral aspect of tissue expander | Procedure | Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | perioperative up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| aesthetic outcome | 1 year | |
| complications (infection, hematoma, capsular contracture) | 1 year | |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason J. Wendel, M.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2345 | United States |
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|
| Serratus anterior to cover lateral aspect of tissue expander | Procedure | Traditional use of serratus anterior for coverage of lateral aspect of tissue expander |
|
| 1 year |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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