1. Why should I use the SUTUREGARD® ISR Device?
The SUTUREGARD® ISR Device makes wound closure easier by providing a way to quickly and gently stretch skin so the tightest part of the wound closure can relax and be easier to close. You may find the whole procedure simpler to perform and not need as much assistance or equipment to complete the closure.
2. I already use pulley sutures or towel clamps for this, why should I use SUTUREGARD® ISR Device instead?
We provide a method that can quickly and gently stretch the skin to allow easier wound closures. Pulley sutures and towel clamps are “all or none”, not gradually adjustable like the SUTUREGARD® ISR Device, which can deliver a customized stretch to any skin type. Also, the SUTUREGARD® ISR Device provides 10x more surface area to cushion the skin than suture, therefore it does not pull through or “cheesewire” the skin. Because it can protect skin from suture trauma, more force can be applied and the skin can be stretched more effectively.
3. But I make my towel clamp technique less traumatic by threading needles parallel to the closure on both sides of the wound and then placing the towel clamp beyond the needles, so the skin does not tear!
You just confirmed our point that towel clamps are traumatic and you have to do extra maneuvers just to protect the skin from them. This is unlike closure with the SUTUREGARD® ISR Device.
4. But I can bill more for a flap or graft, so why use the SUTUREGARD® ISR Device?
Do the flap or graft as you normally would, but use the SUTUREGARD® ISR Device to relax the skin at tight spots and make your life easier in this way:
- Skin Flap: Your flap inset or donor site closure will be easier if you first place the SUTUREGARD® ISR Device at the tightest spot, then close the other areas, then remove it and it is now easier to close the relaxed previously tight spot.
- Skin graft: Use the device to relax tight areas recipient and or donor site skin and use a smaller skin graft with a partial advancement flap via purse-string or other suture technique and bill both procedures, or just make the donor site closure easier.
5. But the SUTUREGARD® ISR Device cost comes out of my billing, why should I pay for it?
Wound closure is faster and simpler with the SUTUREGARD® ISR Device. Many surgeons retain more wound closures in their practice when using the SUTUREGARD® ISR Device. Not only can you avoid lengthy and risky skin flaps, skin grafts and second intent healing, but you do not need to undermine or create dog ears for closure. The SUTUREGARD® ISR Device does the de-tensioning and reshapes circular wounds into elliptical wounds.
6. But I undermine my wounds and that works well. Why change?
Because you get twice as much stretch of the skin when you use stress relaxation rather than undermining! A pivotal study by Melis in Plastic and Reconstructive Surgery (107:1201, 2001) studied 9x9 cm excisional wounds in pigs (closest model to human skin). Wound closure tension was measured at baseline, then after stress relaxation with or without undermining (10 cm in each direction). They noted twice as much reduction in tension with stress relaxation compared to undermining. Then the undermined wounds were stress relaxed and all wounds closed. What was the outcome at 1 week postop? There were significant seromas in all the undermined wounds and not in the stress relaxed group. There was skin necrosis noted in 8/15 undermined wounds and 1/15 not undermined wounds. This is because undermining interrupts perforator blood supply to the skin. This is especially important when working on extremity wounds or in diabetics or smokers, who have reduced blood flow.
7. What do I tell patients?
A simple but clear statement used by many is : “We are going to gently stretch your skin so the wound is easier to close”.
For more detail-oriented patients, you might say: "Your scalp (or other area to be stress-relaxed) does not have much loose skin like the back of your arm or calf. This means that we might need to do something more complex to close the area, like a skin flap or skin graft. We can use the SUTUREGARD® ISR Device to stretch the skin so that we can close the wound as much as possible to avoid a flap/graft. We will use a suture and this device (show them) to protect skin from the tension. We will leave the suture and the device clamped only while we process your tissue and check for full removal of the skin cancer. We may come back to re-clamp it from time to time. You will feel something like a tension headache at the beginning (if on the scalp). This will subside as the skin stretches. Once we are ready to close, we will remove the suture and device and use staples or sutures to close the wound."
Note that the procedures that stress-relaxation can prevent (flaps and grafts) each come with their own short- and long-term consequences. 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).
8. What is the SUTUREGARD® bridge device made from?
The SUTUREGARD® ISR Device is injection molded in the USA using high quality medical grade materials. It is then individually packaged and sterilized in the USA in an FDA-registered facility.
9. How do I use the SUTUREGARD® ISR Device?
See our Instructions for Use for complete details.
10. How does the SUTUREGARD® help with stress/relaxation of the skin?
By reducing the damaging effects of suture on the skin, it enables more force to be applied to the suture, thus allowing more stress-relaxation.
11. How much force can I apply to a suture when using the SUTUREGARD®?
More than you are used to applying!! The amount of force that can be tolerated by the skin will vary with local factors (body site, prior skin damage and any concomitant skin diseases) and systemic patient factors (e.g. immune status, wound healing status). In the scalp, we routinely use up to 25 Newtons (2.5 kg) of suture tension with the SUTUREGARD® ISR Device without adverse effect.
12. What kind of adverse effects should I be aware of?
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.
13. How can I reduce these adverse effects?
A dressing (e.g. Xeroform, Adaptic) can be used under the device. This dressing would absorb moisture and further reduce pressure. For clinical application, see this Case Study.
14. How much stress/relaxation can I expect?
This will vary based on patient factors (e.g. inherent skin elasticity) and site factors (e.g. body location, local scarring radiation therapy). In a trial of 14 scalp wounds, 30 minutes of intraoperative skin relaxation with the SUTUREGARD® ISR Device led to a 65% reduction in force required to close the wound. This stress-relaxation can allow the surgeon to avoid a flap or graft.
15. What are other uses of the SUTUREGARD® ISR Device?
The SUTUREGARD® ISR Device can be used as a “scaffold” to make any wound closure under tension easier. When closing an elliptical wound, the initial midpoint suture requires up to ten times the force of subsequent sutures. The SUTUREGARD® ISR Device can be used to perform an initial high-tension suture to appose the wound edges. While being supported by the SUTUREGARD® ISR Device, sutures or staples can be placed to either side of the device to support the wound. The device can then be removed and, if desired, sutures placed in the middle. See Stoecker et al for more information: Case Study
16. Will the SUTUREGARD® ISR Device work for all my patients?
Skin is highly variable, and some skin will stretch better than others. Some areas on the same person may be more or less elastic. The SUTUREGARD® ISR Device will almost always help but its effects may be limited by prior scarring or radiation, which reduces skin elasticity. Also, there is a limit as to what size of wound can be closed. Our most common closures are 3cm or smaller in diameter. Something 5 cm or greater in diameter on a tight area will be difficult or impossible to close with any technique.
17. Who is NOT a candidate for the SUTUREGARD® ISR Device?
Patients with very tight or damaged skin from prior excisions, prior scarring and/or radiation will not respond well to stress relaxation and though the SUTUREGARD® ISR Device may help, the amount of stretch that can be achieved may be disappointing. Also, patients with very thin skin may not be difficult to stretch without injury, even with use of the protective SUTUREGARD® bridge.
18. Why do you recommend no undermining?
Undermining is a useful technique that can make wounds easier to close but it is almost always not necessary with the SUTUREGARD® Device. This reduces risk of bleeding in the subcutaneous space, and lowers the chance of injuring perforator vessels that provide blood flow to the skin which are necessary for skin survival. It also is faster and easier to close a wound if undermining is not necessary.