SBIR-STTR Award

The most common malignancy in American women is breast cancer. Breast reconstruction for mastectomy currently involves two choices, implant or autologous tissue flap. Implant reconstruction is relatively simpler but is temporary, whereas flap reconstruction is permanent but much more complex. We propose here a novel method for breast reconstruction by implanting a novel three dimensional biodegradable scaffold. This scaffold is designed to accommodate the patient's own omentum and fat tissues. Over time, the scaffold would be completely resorbed, leaving the patient's autologous tissue in the form of a new breast. Our specific aims are as follows: 1) to construct prototypes of the biodegradable scaffold, and 2) to test the prototypes in pigs.

Public Health Relevance:
We propose a novel method for breast reconstruction after mastectomy for breast cancer. Current reconstruction involves two choices, implant or autologous tissue flap. Implant reconstruction is relatively simpler but is temporary, whereas flap reconstruction is permanent but much more complex. Complications in implant breast reconstruction are 2-3 folds higher than in breast augmentation, and the typical implant only lasts a few years. Flap reconstruction operations take several hours; require a hospital stay of approximately 4-5 days and subsequent outpatient rehabilitation of approximately 4-6 weeks. The patient then has one or more permanent large scar(s) at the donor site(s). Our novel method would achieve the long-term benefits of autologous tissue transfer with much less operative morbidity than the current flap reconstruction.

Thesaurus Terms:
American; Autologous; Body Tissues; Breast; Breast Reconstruction; Cancer Of Breast; Cancers; Cicatrix; Complex; Family Suidae; Fats; Fatty Acid Glycerol Esters; Flaps; Hour; Implant; Island Flaps; Left; Length Of Stay; Malignant Neoplasms; Malignant Tumor; Malignant Tumor Of The Breast; Malignant Neoplasm Of Breast; Mammaplasty; Mammectomy; Mastectomy; Methods; Morbidity; Morbidity - Disease Rate; Number Of Days In Hospital; Omental Fat; Omentum; Operation; Operative Procedures; Operative Surgical Procedures; Out-Patients; Outpatients; Patients; Physical Health Services / Rehabilitation; Pigs; Rehabilitation; Rehabilitation Therapy; Rehabilitation, Medical; Scars; Site; Suidae; Surgical; Surgical Flaps; Surgical Interventions; Surgical Procedure; Swine; Testing; Time; Tissues; Woman; Design; Designing; Hospital Days; Hospital Length Of Stay; Hospital Stay; Malignancy; Malignant Breast Neoplasm; Neoplasm/Cancer; Novel; Porcine; Prototype; Public Health Relevance; Reconstruction; Rehabilitative; Scaffold; Scaffolding; Suid; Surgery

The most common malignancy in American women is breast cancer. Breast reconstruction for mastectomy currently involves two choices, implant or autologous tissue flap. Implant reconstruction is relatively simpler but is temporary, whereas flap reconstruction is permanent but much more complex. We propose here a novel method for breast reconstruction by implanting a novel three dimensional biodegradable scaffold. This scaffold is designed to accommodate the patient's own omentum and fat tissues. Over time, the scaffold would be completely resorbed, leaving the patient's autologous tissue in the form of a new breast. This new method would offer a third choice for breast reconstruction that may potentially be superior to the current options. The goals of this proposal are to perform necessary pre-clinical tests on the Biobreast scaffold device to enable a pre-IDE application to the FDA for approval of initiation of a future Phase 1 human clinical trial. Our specific aims are as follows: Aim #1: To carry out bench performance tests of the scaffold. Aim #2: To complete animal and toxicity studies of the scaffold. Aim #3: To submit a pre-IDE application to the FDA.

Public Health Relevance Statement:


Public Health Relevance:
Breast reconstruction for mastectomy currently involves two choices, implant or autologous tissue flap. Implant/expander reconstruction is relatively simpler but is temporary, with operative time about 1-3 hours and 1-2 day hospital stays. Complications in implant breast reconstruction are 2-3 fold higher than in breast augmentation, and the typical implant only lasts a few years. Flap reconstruction is permanent but much more complex, requiring lengthy (6-12 hours), more costly operations, 4-6 day inpatient care, and 6-8 weeks of outpatient rehabilitation. The patient then has one or more permanent large scar(s) at the donor site(s). We propose here a novel method for breast reconstruction by implanting a novel three dimensional biodegradable scaffold. This Biobreast scaffold is designed to accommodate the patient's own omentum and fat tissues. Over time, the scaffold would be completely resorbed, leaving the patient's autologous tissue in the form of a new breast. Our proposal represents a novel solution by constructing a bioabsorbable scaffold to: 1) provide a breast shape to the omental tissue, and 2) to increase volume for reconstruction by providing a vascular supply to added autologous fat derived from liposuction. Our Biobreast scaffold offers potentially major advantages to the current methods of breast reconstruction as follows: 1) Scaffold reconstruction is tissue-based without a permanent foreign body like an implant with its associated high complication and re-operation rate. 2) Operative time is several hours shorter than traditional flap reconstruction, and blood loss is significantly less, thus minimizing stress o the patient's body. 3) Postoperative monitor requirement is much less intensive than that for free flaps. 4) Hospital stay length is shorter, 1-2 days, and potentially not needed if the healthy patient goes home the same day. 5) Rehabilitation is anticipated to be many weeks less than traditional flap reconstruction. There is no permanent muscle loss, no large scars and potential defects at the flap donor site(s).

Project Terms:
American; Animals; Autologous; base; Breast; Cancer Etiology; Carcinoma in Situ; Caring; Cessation of life; Cicatrix; Clinical Trials; Complex; Complication; Defect; design; Development; Devices; Diagnosis; Fatty acid glycerol esters; Foreign Bodies; Future; Goals; Hemorrhage; Home environment; Hour; Human; Implant; Inpatients; Left; Length of Stay; malignant breast neoplasm; Malignant Neoplasms; Mammaplasty; Mastectomy; Methods; Monitor; Morbidity - disease rate; Muscle; novel; Omentum; operation; Outpatients; Patients; performance tests; Phase; Postoperative Period; pre-clinical; public health relevance; reconstruction; Rehabilitation therapy; scaffold; Second Primary Cancers; Shapes; Site; Solutions; Stress; Suction Lipectomy; Surgical Flaps; Testing; Time; Tissues; Toxic effect; Vascular blood supply; Woman