Breast Cancer
Conditions
Keywords
Breast Tissue Expander Placement, Stimulan Rapid Cure, Local Antibiotic Delivery, Prevent Infection, 25-278
Brief summary
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.
Interventions
PROCEDURETissue Expander (TE)
Tissue Expander (TE)
DRUGVancomycin and Gentamicin
Given through Stimulan Rapid Cure during surgery
DEVICEStimulan Rapid Cure
Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a randomized controlled study to compare the outcomes of immediate tissue expander (TE)-based breast reconstruction with and without antibiotic beads.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female sex * Aged 18 years or older * Planned to undergo mastectomy for breast cancer, genetic predisposition to and/or strong family history of breast cancer, or other prophylactic indication * Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK * BMI less than 40 kg/m2 * Not actively smoking or using other nicotine products within 6 weeks of surgery * No contraindications to Stimulan antibiotic bead placement: hypercalcemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, and severe degenerative bone disease * No known allergy to calcium sulfate, vancomycin, or gentamicin * No impaired decision-making capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads) | within 90 days postoperatively | 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 |
| Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only) | within 90 days postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads) | within 90 days postoperatively | 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. |
| Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only) | within 90 days postoperatively | 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. |
Countries
United States
Contacts
CONTACTDanielle Rochlin, MD
CONTACTBabak Mehrara, MD
PRINCIPAL_INVESTIGATORDanielle Rochlin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed