Nearly 55 million people annually undergo surgical procedures which require an incision closure. Of these patients, 40-90% of them will bear a scar as a result of this procedure, resulting from a combination of closure choice, clinician skill, and the incision itself. While typically justified by the necessity of the surgery, a Holy Grail of modrn medicine has long been scar-free wound-healing. VitaSuture Absorbable Surgical Suture, a fast-absorbing non- inflammatory suture based upon fibrin microthread technology represents a key step forward. Nowhere is the margin for success slimmer or the envelope pushed harder in this pursuit than in the field of aesthetic facial surgery. The high-visibility and high-sensitivit procedures carried out nearly 1.6 million times last year in the United States as elective procedures demand a best- possible result in every case. The current gold-standard for high-visibility incision wound closure is typically absorbable or non-absorbable suture which affords the clinician the control to precisely align and tension the wound edges for an optimal outcome. Even still, despite the talent of surgeons and current suture technology, suture-related adverse events are thought to occur in more than 3% of cases including such things as chronic fibrosis, scar deposition, inflammation, and suture extrusion. Even removal of non-absorbable sutures shortly after initial incision closure result in moderate disruption to the host environment, prolonged patient discomfort, and additional procedural time. VitaSuture Absorbable Surgical Suture, a novel fibrin microthread-based suture offer the ability to close incision wounds with a fast-absorbing surgical suture eliciting virtually no host response. The reason for VitaSuture' exceptional host compatibility is due to the use of fibrin microthreads in its construction. A component of native wound healing, fibrin is well-tolerated in vivo and is resorbed by enzymes such as plasmin naturally occurring during wound healing. This work will identify a VitaSuture configuration which is both mechanically and biologically viable as a suture product. Initial efforts will refine the mechanics of the constituent fibrin microthreads, followed by mechanical refinements to the assembled device, and concluded with mechanical and biological evaluation using the rat dermis to model incision wound healing. This proposal presents a unique marriage between the native function of a biomaterial, a novel format, and a market need driven by a team who prioritize commercialization.
This proposal will generate initial proof of the concept that VitaSuture absorbable surgical suture, a unique fibrin microthread-based suture, is capable of low-tension incisional wound closure while generating no inflammation and rapidly resorbing in the patient. Such a device would be expected to find ready and broad application in a number of high-visibility or high- sensitivity wound closure roles, areas such as the face and eyes being likely initial targets for use representing over 600,000 cases annually. Subsequently, the initial VitaSuture product would be expected to serve as a segue to more advanced second generation products used to deliver scar-suppressing pharmaceuticals, seeking to move into a patient space of as many as 100M patients globally susceptible to keloid scarring.