Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LifeCell
nothing to add
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
An ASA Physical Status Classification5 of 1 or 2 (see App I)
Estimated life expectancy \> 1 year
You may not be if
Clinically significant systemic disease
Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
Predicted excised breast mass of \>750 gms
Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
Need for tissue flap in addition to expander
History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate
Clareo Health | Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
