Traditional clinical studies typically exclude certain patient types, limiting the ability for such studies to capture real world conditions. Additionally, these studies require formal approval from review boards before changes can be made, stifling the adaptability of the project to adjust to new information. With a clinical quality improvement (CQI) project, there is greater flexibility due to the absence of rigid guidelines and a lack of patient exclusion criteria, all of which allows for more real world conditions to be more accurately represented.
“We embarked on a CQI project in place of Gore’s historical approach to clinical studies to enable us to include a more representative patient sample and adapt to clinical findings in real time,” said Ron Anderson, general surgical products business unit leader at Gore. “The CQI framework allows the flexibility to implement changes to improve patient care throughout the evaluation period meaning improvements in quality, safety, satisfaction, cost and outcomes.”
The project is following a diverse collection of metrics including demographics, pre-operation health, operation details, post-operation health, short- and long-term follow up, and costs. The CQI paradigm empowers participants to efficiently respond to these data, as they are collected.
“While there is certainly benefit to the traditional model of clinical studies, having the flexibility to adjust the project parameters as new information is uncovered is a benefit we need to take advantage of on these studies,” said Kevin D Jackson, president and CEO of Surgical Momentum. Dr. Bruce Ramshaw, chairman of the Department of Surgery at the University of Tennessee Graduate School of Medicine in Knoxville, and a founder of Surgical Momentum as well as a participating physician in the Gore Synecor Biomaterial CQI Study, said “I want to improve patient outcomes as quickly as possible, and the CQI model allows for that adaption at a much faster pace than traditional clinical studies.”
The Gore Synecor device being evaluated in this CQI project is designed to improve hernia treatment. Hernia repair has traditionally required a surgeon to choose between a permanent material for a durable, single-stage repair, and absorbable, non-permanent materials where there are factors that may require a different approach. Gore Synecor Biomaterial is comprised of three materials, including:
- Gore Bio-A Web, a tissue-building scaffold with proven outcomes, provides rapid vascularization and ingrowth for complex repairs
- A macroporous knit of dense, monofilament polytetrafluoroethylene fiber that provides strength for a durable, single-stage repair and may reduce the risk of harboring bacteria due to the solid fiber
- Nonporous PGA/TMC* film that minimizes tissue attachment to the device at the visceral side
*Polyglycolic acid / Trimethylene carbonate
Gore Medical's products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery.