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preliminary analysis showed no difference
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The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | No Intervention | Standard treatment | |
| Use of Mesna | Experimental | Standard surgical procedure with Mesna |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesna | Drug | B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Shack, MD | Vanderbit Unviersity Medical Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard | Standard procedure or capsulectomy for removal of capsule; |
| FG001 | Mesna | The use of Mesna of removal of capsule for capsular contracture. Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants with capsular contracture after breast implants that elected to have capsule removed and implant exchanged; followup for recurrence of capsulsar contracture
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard | Standard procedure or capsulectomy for removal of capsule; no mesna Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed |
| BG001 | Mesna |
| 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 | Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care | Posted | Number | participants | one year |
|
one 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 | Standard | Standard procedure or capsulectomy for removal of capsule; |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Bruce Shack, MD | Vanderbilt University | 615-936-0160 | bruce.shack@vanderbilt.edu |
| ID | Term |
|---|---|
| D057910 | Implant Capsular Contracture |
| ID | Term |
|---|---|
| D005549 | Foreign-Body Reaction |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015080 | Mesna |
| ID | Term |
|---|---|
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care | Posted | Number | participants | one year |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Mesna | The use of Mesna of removal of capsule for capsular contracture. Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed | 0 | 11 | 0 | 11 |
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| D011475 | Prosthesis Failure |
| D011183 | Postoperative Complications |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |