1. What is SUTUREGARD Intraoperative Skin Relaxation (ISR) Device?
The SUTUREGARD ISR is a sterile, medical grade plastic device used to aid optimal wound closure. It helps the surgeon apply tension and “stress/relax” the skin to make your wound easier to close. It is used for a short time (30-45 minutes) and removed after final wound closure.
2. What is stress relaxation?
Skin is a stretchy fabric. Like many fabrics that are partly elastic, the more times it is stretched, the more it relaxes and can therefore stretch more easily. It is kind of like how your blue jeans are when you first put them on after taking them out of the dryer, tight at first, but with motion and stretch, the fabric relaxes.
3. Will it cost me? Will my insurance cover it?
Your surgeon has the option of bundling the cost of the device with the procedure or charging you for the device, itself.
If your surgeon can use SUTUREGARD to close your wound in the office, it can save you considerable cost in lost time from work, lifestyle and save you copays from surgery in the operating room or additional visits for wound care.
4. Has this been used before?
This device and method have been used to close hundreds of human skin wounds. There is also a growing literature on the technique that can be browsed on our Publications page.
5. Is it safe?
The SUTUREGARD ISR Device has been safely used in hundreds of wound closures. The SUTUREGARD® Intraoperative Skin Relaxation Device is indicated for intraoperative support and/or skin stress-relaxation of non-contaminated, acute surgical wounds of LESS THAN 3.0 cm width. While the device has been designed to absorb the force of a high-tension suture, excessive force applied for prolonged durations may lead to pressure injury. Pressure injury may involve damage to the epidermis, dermis, fat or underlying structures such as nerve, muscle or bone.
6. What if it can't close my wound?
Some wounds are too big or under too much tension to be fully closed with the SUTUREGARD ISR Device. Your surgeon will determine how much stretch can be safely achieved for your wound. In some cases, the central portion of the wound will not be able to be closed. In that case, the surgeon may use a skin graft on the unclosed portion or simply allow that area to heal on its own (this is called second intent healing).
7. What does the SUTUREGARD ISR Device do, specifically?
The SUTUREGARD ISR Device increases the surface area of suture. It is also covered in a soft overmold to soften the use of suture to close wounds. Spreading the force over a much larger area, pressure is reduced, allowing much higher tension sutures to be employed to successfully do skin stress-relaxation. The SUTUREGARD ISR Device also has a "spring-like" tendency so it will try to return to its original shape. As the skin around the wound stretches, the device will naturally adjust itself to the decreasing wound tension.
8. How do sutures damage the skin?
Pressure from suture laying on the skin can damage the skin. Pressure is related to surface area. A narrow strong, suture under tension creates a lot of pressure on a small area and can compress and cut through skin. The SUTUREGARD ISR Device optimizes suture technology by making sutures more gentle on the skin.
9. What is it made of?
The SUTUREGARD ISR Device is made of medical grade polymers (plastics) that have been tested for safety on the skin. The insert is made of polypropylene and the overmold is made of thermal plastic elastomer.
10. Where is it made?
The SUTUREGARD ISR Device is manufactured, packaged and sterilized in the USA.
11. Does it hurt?
During stress-relaxation of the scalp, patients usually describe a tightness in the site. Most describe it as a tension headache, rather than "pain". The amount of tension and headache dissipates quite quickly (within 5-10 minutes). Most patients will have some degree of headache after stress-relaxation of the scalp, which lasts for 2-3 days. Mild discomfort from the stress relaxation process can occur in any part of the body but usually subsides quickly.
12. If the SUTUREGARD ISR Device is used instead of performing a skin flap or skin graft, what am I avoiding?
Flaps and grafts require harvesting healthy skin from an area on your body to repair the surgical defect. This requires healing in those areas too. In addition, flaps can result in short-term pain and long-term numbness and alteration of hair patterns. Grafts usually have long-term alopecia (no hair) and poor sensation (depending on if they are split- or full-thickness).