through research, development, and education in order to
improve the clinical care of surgical patients."
The Surgical Therapeutic Advancement Center (STAC) at the University of Virginia (UVA) is an academic research center dedicated to the development of innovations in the field of surgery in order to improve the clinical care of patients. Our collaborators include some 30 UVA faculty members whose efforts are coordinated through one central office under the direction of Dr. William D. Spotnitz.
Recently, Dr Spotnitz received his M.B.A. and was elected to the national business school honor society Beta Gamma Sigma. In keeping with the mission of STAC to improve the clinical care of surgical patients, an additional effort is being made to support business development of quality surgical devices through consultation services. These consultation services are being provided over a wide range of topics from device development all the way through regulatory approval. Additional details are provided in the menu under the consultation services section.
Our clinical expertise in protocol development, implementation, execution, and publication extends throughout the surgical departments at the University of Virginia. Experience has been obtained in a wide variety of clinical trials (single and multi-center, including international) with many surgical specialties and related fields, including head and neck surgery, general surgery, orthopedic surgery, neurosurgery, plastic surgery, hematology, and radiology. The Center has particular strengths in the areas of cardiovascular and thoracic surgery, tissue adhesive research, as well as transfusion medicine. STAC is experienced with Phase I, II, III, and IV studies, and conducts all research with adherence to Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) guidelines. The Center boasts certified Clinical Research Coordinators and trained support personnel dedicated to the efforts of clinical research.
Education remains a key focus point of the Center, with local, regional, national, and international presentations conducted for large and small groups. Workshops featuring clinical animal laboratory models, and clinician-to-clinician interaction are possible. All educational efforts focus on objective presentation of information in a practical, realistic format which emphasizes clinical judgment and improved patient care.
STAC exists through the nurturing support of a large number of industrial collaborators as a result of unrestricted grant funding and specific contractual agreements. Proprietary interests of individual sponsors are carefully protected. Intellectual property developed at the University of Virginia may be patented through the University Patent's Foundation.
Services Available Through STAC May Include:
- Cell Biology Group
- Wound Healing Laboratories
- Proof of concept testing
- Large and small animal models for preclinical testing
- Efficacy evaluations
- Comparison studies for product revision and improvement
- Experienced laboratory staff
- Regulatory strategy advice and assistance
- Protocol development and revision
- Clinical steering committee leadership
- Site selection support and maintenance
- Source document review and editing
- Case Report Form review and editing
- Clinical trial support by certified Clinical Research Coordinators with strong clinically based nursing backgrounds
- Subject enrollment and data collection according to GCP/ICH standards
- Data management and analysis by UVA Department of Health Evaluations Sciences
- Scientific publication preparation
- Organization of Continuing Medical Education conferences, workshops and guest speaker appearances
- Formatting presentations to optimize learning for multidisciplinary/international groups including physicians, nursing, and allied health personnel as well as industry professionals
- Creation of didactic, small group, and laboratory events
- Facilitating Speakers' Bureau/Guest Lecturer series
- Preparation of peer-reviewed journal manuscripts
- Authorship of chapters/books
- Providing Visiting professorships/fellowships
- Determination of surgeon needs
- Device design
- Device testing in bench and clinical environments
- Financial sponsorship
- Clinical trial execution
- Regulatory approval
- MSL and sales personnel organization and education
- Post market clinical trials
- Advisory board participation
- Market assessment and strategy
Tissue Adhesive Center
The Tissue Adhecive Center (TAC) is a specialty center within the Surgical Therapeutic Advancement Center. TAC's broad clinical experience over the past 25+ years with the field of tissue adhesives provides a unique expertise into the clinical uses of a variety of matierials and has helped to produce a large number of publications including 80 adstracts, peer-reviewed journal articles, and books. TAC's database of clinical tissue adhesive use within the institution provides unique insight during a period of rapid growth in thi sportion of the healthcare market.
The Tissue Adhesive Center (TAC) Clinical research in this field explores indications for a variety of tissue adhesives and related surgical devices including hemostatic agents, tissue sealants, wound closure systems, and drug carriers.
Areas of basic and preclinical research include wound healing, novel adhesive characterization, relevant clinical animal modeling for efficacy assessments, and device evaluation.