Evaluation of the Cook Biodesign Plastic Surgery Matrix
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2011 |
| End Date: | December 2013 |
| Contact: | David Hucks |
| Email: | dhucks@cookbiotech.com |
| Phone: | 765-497-3355 |
A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix
Patients with a desire for nipple reconstruction following breast cancer and breast
reconstruction will receive a surgical procedure to reconstruct one or both nipples
utilizing the COOK(r) Biodesign(r) Nipple Reconstruction Cylinder.
Inclusion Criteria:
- Patient presents with a history of breast cancer, having previously completed either
uni- or bi-lateral breast removal and reconstruction.
- Patient presents with a desire to obtain nipple reconstruction
- Patient is at least 18 years of age
- And other inclusion criteria
Exclusion Criteria:
- Patient is not medically fit enough for surgery under local anesthesia
- Patient is currently smoking, using tobacco products, or nicotine products (i.e.
patch, gum, or nasal spray)
- Patient is pregnant, breastfeeding or planning further pregnancy during the study
period
- Patient has physical allergies or cultural objections to the receipt of porcine
products
- And other exclusion criteria
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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