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SUTUREGARD® ISR Device

SUTUREGARD®
Intraoperative Skin Relaxation Device

Description

SUTUREGARD® Intraoperative Skin Relaxation Device is comprised of two components: (1) a sterile deformable suture bridge with soft elastomer covering and (2) a sterile circular suture guide with central aperture to collect suture ends.

Intended Use

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.

Warnings

(i) Do not reuse. This product is intended for single use, one patient only. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. (ii) Do not re-sterilize the bridge or suture guide. (iii) Discard open, unused devices. (iv) Do not use if package is open, torn or damaged.

Precautions

Excessive force applied for prolonged durations may lead to pressure injury. The amount of force and duration of application that are tolerable will vary with patients and wound location. If the method is used beyond a given wound’s tolerability of pressure and/or duration, pressure injury may result. For those reasons, we recommend minimizing the duration and tension as much as possible. In clinical trials, most stress-relaxation occurs within the first 30 minutes of application. (View Publications)

Possible Adverse Effects

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.

Product Ordering

To order directly in the US or for product information, visit us at: https://suturegard.store/

Suggested Method of SUTUREGARD® Intraoperative Skin Relaxation

The SUTUREGARD® Intraoperative Skin Relaxation Device is indicated for intraoperative support and/or skin stress-relaxation of acute, non-contaminated surgical wounds of LESS THAN 3.0 cm width. The SUTUREGARD® Intraoperative Skin Relaxation Device should be selected for use depending upon patient condition, surgical experience, surgical technique, condition of peri-wound skin, wound size and wound tension. The device must be removed within 5 hours of application. In most instances, the device will be removed within 60 minutes of initial placement.


Suture

It is recommended to use a large caliber (e.g. USP 2-0 or larger) nonabsorbable (e.g. nylon) suture with appropriate needle to puncture skin. The suture is placed with large bite size (e.g. 10mm) so that the suture passes through the full thickness of skin on each side of the wound. We STRONGLY recommend removal of the surgical needle at this point.

Thread

Insert one suture end into each slot of the SUTUREGARD® bridge with the centrally elevated eversion bump pointing away from the skin (as shown). Optionally, the suture ends may be inserted through the SUTUREGARD® washer (as shown).

Stretch

Apply tension to suture ends and secure with a clamp (as illustrated) or knot. If a clamp is used, it can be un-clamped to allow tension re-adjustment every 5-10 minutes (or at discretion of surgeon) and re-clamped.

CAUTION: Excessive suture tension may impart pressures on skin that may lead to pressure injury. The ability of a wound to tolerate pressure is dependent on many variables and requires surgeon judgement on a case-by-case basis.

Close

Close sides of wound with suture and/or staples.

REMOVE the SUTUREGARD® bridge and washer from the wound. DISCARD the SUTUREGARD® bridge and washer immediately after removal.

The central portion of the wound can be closed or allowed to heal second intent as per surgeon preference.


How To Open Sterile Package

Remove the SUTUREGARD® Device from its package in an aseptic environment using talc-free gloved hands.

  1. Peel open the package.
  2. Invert package over sterile field, allowing the bridge and suture guide (washer) to gently fall into sterile field.
  3. Discard packaging.

Frequently Asked Questions

How much tension can be applied to the wound?

In clinical trials of SUTUREGARD® device-assisted stress-relaxation, up to 25 Newtons (2.5 kg) of force has been applied to the suture. With such tensions, adverse events are uncommon (less than 10%) and include superficial pressure injury. In most cases, such injury heals within several weeks of routine wound care.

How do I prepare the wound for stress-relaxation?

The wound should be prepared with a standard surgical preparation at the start of the procedure. Prior to applying tension to the suture, the skin around the wound should be clean and dry.

How do I care for the wound after surgery?

The SUTUREGARD® bridge and washer MUST be removed and discarded prior to the final wound closure and application of dressings. Wound care and support (e.g. staple, suture) removal can be according to surgeon preference.

What kind of clamp do you recommend to secure the sutures?

We typically use the lightest available hemostat. Use of a heavier hemostat or needle driver will put asymmetrical pressure on the SUTUREGARD® Device, increasing the risk of pressure injury.


What is Intraoperative Stress-Relaxation of the Skin?
Creep vs Stress-Relaxation

Stress-relaxation is a corollary of the more common term, “creep”. When skin is put under force or tension by internal or external tissue expanding “devices”, it stretches (creeps). There are two forms of creep: mechanical and biological.

Mechanical creep occurs quickly (intraoperatively), within minutes to hours, and results in stretching or lengthening of the skin because of the breakdown of the dermal framework. For example, polypropylene suture will creep (and eventually break) when under increasing amounts of tension.

Biological creep occurs over weeks to months (staged tissue expansion) and is the result of the production of new tissue and recruitment of surrounding tissue. The stretching of abdominal skin in pregnancy is an example of biological creep.

Not only does the skin elongate (mechanical creep) when enough force or tension is applied, but the force required to maintain that stretch of the skin reduces over time. This reduction of force (i.e. tension of skin around a defect) required to maintain a stretch is the property of stress-relaxation.

When repairing surgical defects, wound closure tension is more important than wound closure size. Most people are aware that a large wound in one part of the body may be very easy to close, while the same size wound in another part of the body may be under too much tension to approximate. For example, a 2.5cm wide wound on a calf may be relatively easy to approximate, while the same size wound on the shin could be very difficult. Thus, when discussing methods to facilitate wound closure, it is customary to discuss “stress relaxation” rather than creep.

How does the SUTUREGARD® ISR Device help with Creep and Stress-Relaxation?

The SUTUREGARD® Intraoperative Skin Relaxation (ISR) Device is a suture bridge that allows large amounts of force to be applied to skin for the purposes of achieving mechanical creep and stress-relaxation of skin surrounding a wound without tearing the skin or damaging the wound edges.

You can think of the SUTUREGARD® ISR Device like a snowshoe. Without a snowshoe, a person walking through deep snow with snow boots would sink into the snow. With the snowshoe, the boot’s surface area is increased thereby decreasing the pressure of the boot on the snow, allowing the person to walk on top of the snow.

Prior to the SUTUREGARD® ISR Device, devices to create mechanical creep and stress-relax skin were more cumbersome and involved more skin punctures to the skin.

Relax & Close, More Wounds, More Simply.

Making wound closure easier for surgeons and better for patients.

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