SUTUREGARD is on a mission to close more wounds simply and safelySmartTRAK Spotlights SUTUREGARD medical, a privately held medical device firm with patented technology that allows surgeons to perform simple closures of high-tension wounds through rapid intraoperative tissue expansion.
Founded in 2015 and based in Portland, Oregon, SUTUREGARD™ Medical, Inc. is a privately held medical device firm with patented technology that allows surgeons to perform simple closures of high-tension wounds through rapid intraoperative tissue expansion. For skin cancer surgeons (Mohs Surgeons), SUTUREGARD’s initial target market, the SUTUREGARD™ device allows closure of wounds using tissue expansion instead of relying on flaps, grafts, or second intent healing. This is particularly useful for scalp and lower leg closures. For some skin cancer surgeons, this will add greater efficiency to their day. For other skin cancer surgeons, this will retain closures in their practice that they would have otherwise sent to other specialists.
The Company founders — a Corvallis, Oregon-based skin cancer (Moh’s) surgeon and his Ph.D. nurse business partner — designed the SUTUREGARD device. The Company invested three years conducting bench research, pre-clinical studies, and customer discovery prior to completion of a successful human use study in 2018.
The Problem and The Solution
The Problem: Skin cancer surgery can result in wounds that are too big to close with normal suture technique. In this case, complex procedures are used such as skin grafts and skin flaps.
The Solution: The SUTUREGARD device is a patented, bioengineered surgical device that allows surgeons to quickly stretch the skin during surgery. SUTUREGARD Medical has termed this stretching technique as, “Rapid Intraoperative Tissue Expansion” or “RITE.”
Human skin has an elastic component that will stretch and return to its original form when tension is released. It also has a viscous component that will not return to its original form upon the release of tension – it remains in a stretched configuration. This viscous transformation occurs through parallelization of collagen fibers, extrusion of water from the extracellular matrix, and direct mechanical effects on elastin and collagen.
It is difficult to apply high enough tension to human skin to fully reach its viscoelastic limit. Conventional sutures may tear through the skin (“cheesewiring”) when this degree of tension is applied. The SUTUREGARD device – a mechanical device that is interposed between the skin and suture on the skin surface – addresses the issues caused by the use of conventional sutures. It has been specially designed to reduce the forces transmitted to the skin under high tension suturing conditions. The technology works by cushioning the skin from the suture in a way that allows the surgeon to apply much higher tensions than are normally possible and reach the full viscoelastic limit of the skin without the suture tearing. The bridged design prevents pressure on the wound margins and allows uninterrupted blood flow to the skin edges. With the SUTUREGARD device technology the surgeon can achieve rapid tissue expansion and can do more primary closures on difficult to close wounds. (See Figure 1.)
SUTUREGARD Wound Closure
Although current indications for use are directed to short-term use in excisional wounds, the SUTUREGARD device could eventually also be used as an improved suture retention bridge, providing reinforcement and everted closures of high-risk, dehiscence prone wounds. The SUTUREGARD device has a short learning curve and is used in combination with standard surgical instrumentation found in any operating room or surgery office.
Using the RITE stretching technique, SUTUREGARD works intraoperatively through the following steps:
Potential Synergies with Negative Pressure Wound Therapy (NWPT)
SUTUREGARD Medical envisions synergy with NPWT, as the surgeon initially achieves maximal closure of a wound with skin loss via use of SUTUREGARD for RITE -- then applies NPWT for edema reduction, mechanical support, etc.
Multiple skin cancer surgeons have used the SUTUREGARD device in more than 100 cases. In addition, there are plans for a 300-patient pivotal trial which will allow surgeons from multiple specialties and the military to trial the SUTUREGARD device for the following applications: traumatic skin defects, difficult-to-close revision surgery, challenged skin (aged, thin, scarred, radiated), and poorly perfused skin (amputation closures).
The SUTUREGARD device has been tested and validated in a human clinical study (n=42 wounds in 40 skin cancer excision patients). The findings showed convincingly that wounds that were not able to be closed with normal techniques were effectively closed with the use of the SUTUREGARD rapid tissue expansion device and subsequent closure. In some cases, the device was used for as little as one hour; in others, the device was left in place overnight, as determined by the surgeon.
The SUTUREGARD device is a Class I, 510(k)-exempt device, registered with the FDA.
High return on investment for Patient, Provider and Payor:
Clinically validated design:
Keys to Success
For more information go to Suturegard.com.