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The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue expanders placed during mastectomy. The researchers will also study whether Stimulan Rapid Cure affects the risk of seroma, a possible complication of surgery that involves fluid buildup under the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients randomized to Tissue Expander (TE) + antibiotic beads | Experimental |
| |
| Patients randomized to Tissue Expander (TE) only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Expander (TE) | Procedure | Tissue Expander (TE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads) | The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology [seroma, radiation]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively | within 90 days postoperatively |
| Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only) | The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology [seroma, radiation]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively | within 90 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads) | Seroma is defined as >50 cc of periprosthetic fluid that is aspirated during tissue expansions or otherwise drained (e.g., by Interventional Radiology). Seroma will be assessed at the patient level such that unilateral or bilateral seroma in a patient will be considered a single seroma event for the purposes of analysis. |
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Inclusion Criteria:
Breast Cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Rochlin, MD | Contact | 646-608-8033 | rochlind@mskcc.org | |
| Babak Mehrara, MD | Contact | 646-608-8639 |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Rochlin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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This is a randomized controlled study to compare the outcomes of immediate tissue expander (TE)-based breast reconstruction with and without antibiotic beads.
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| Vancomycin and Gentamicin | Drug | Given through Stimulan Rapid Cure during surgery |
|
| Stimulan Rapid Cure | Device | Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery |
|
| within 90 days postoperatively |
| Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only) | Seroma is defined as >50 cc of periprosthetic fluid that is aspirated during tissue expansions or otherwise drained (e.g., by Interventional Radiology). Seroma will be assessed at the patient level such that unilateral or bilateral seroma in a patient will be considered a single seroma event for the purposes of analysis. | within 90 days postoperatively |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| 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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| ID | Term |
|---|---|
| D015625 | Tissue Expansion Devices |
| D014640 | Vancomycin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
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