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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
Tissue Expander (TE)
Given through Stimulan Rapid Cure during surgery
Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGSurgical site infections (SSI) incidence
We will 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
Time frame: within 90 days postoperatively
Compare the rates of seroma
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.
Time frame: within 90 days postoperatively
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States
RECRUITING