HEMIGARD^® ARS Device

HEMIGARD^®​
Adhesive Retention Suture Device

Closing acute wounds under tension is challenging. Suture can rip through the skin, second intent healing can take months with frequent dressing changes, and flaps and grafts have a high rate of complications, such as dehisence.

The HEMIGARD^® ARS device was created to address these problems.

The HEMIGARD^® bolsters skin strength to enable high tension linear wound closure without skin ripping.

The HEMIGARD^® has 3 zones of action: (1) a rigid and waterproof zone with that faces the wound and will not rip under high tension, (2) a middle zone that is less stiff, but still waterproof, and (3) a trailing zone with low stiffness to lessen the risk of shear-induced blistering at the trailing edge.

HEMIGARD^® ARS device
How it works

The HEMIGARD^® ARS is intended to be used to close surgical wounds surrounded by clean and dry skin with minimal hair. After preparing the skin, one HEMIGARD^® ARS strip is laid on each side of the wound with holes facing the wound, about 10mm or more from the edge of the wound. Then, a retention suture is placed by piecing its needle down through the hole on one of the HEMIGARD^® ARS strips. The same needle is then pierced up through the hole of the second HEMIGARD^® ARS strip on the other side of the wound. Two holes are in each strip allowing surgeons to suture with a simple interrupted pattern (one hole) or vertical mattress pattern (two holes).

Next, the surgeon applies tension by pulling the suture so that the wound edges come together. To facilitate placement of dermal sutures, it is helpful to leave a gap of 2-3mm between wound edges. After adequate tension has been applied, the retention suture is knotted and remains in place until suture removal.

Dermal sutures are performed next, prior to completion of a superficial closure (e.g. sutures, staples, adhesives).

Patients are given wound care instructions, which encourage keeping the HEMIGARD^® ARS strips clean and dry. Also, if the lateral zones start to peel off the skin, they should be taped down with bandages, rather than cut off.

For most leg wounds, it is advisable to have patients restrict activity, elevate the leg and, unless there are contraindications, use some form of external compression to mitigate swelling. The patient’s overall, vascular and skin health must be considered when choosing any dressings and/or external compression.

The HEMIGARD^® ARS can be retained for up to two weeks to provide postoperative protection from skin tearing. At removal, the retention suture is first cut, removed and discarded. Then, the rigid inner zone of each HEMIGARD^® ARS strip is lifted off the skin. Grasp that portion and gently pull directly opposite to the wound. If there is resistance, place warm soaks on the HEMIGARD^® ARS strips for several minutes prior to re-attempting.

Remove and discard both HEMIGARD^® devices. If appropriate, remove any residual non-absorbable wound supports. Provide patient with instructions on further wound care (e.g. steristrips, when to return to activities)

Prepare

Clean and thoroughly DRY a 6cm long area for the HEMIGARD® ARS strips on each side of the wound.

Adhere

Place HEMIGARD® ARS strips so that the hole closer to the wound is 10mm from the wound edge. Ensure adhesion of the strips to skin.

Suture

Suture 2-0 nylon (or similar) suture through the holes of the HEMIGARD® ARS and full thickness skin prior to closing the wound.

Finish Closure

After placing additional dermal or percutaneous sutures, staples, or glue, ensure that the HEMIGARD® ARS strips remain DRY for AT LEAST 5-7 days.

*Please refer to the Instructions for use for additional information.

How HEMIGARD®^® ARS
Makes Standard Sutures Better

1. Less stress at wound edge than sutures alone

As seen in this finite element analysis (FEA) of skin closure, a standard suture (at left) creates a zone of high stress (RED) at the wound edge. Stress leads to reduced perfusion and to skin tearing. HEMIGARD® ARS (at right) disperses the stress of a standard suture away from the wound edge.

Enhanced perfusion of elliptical wound closures using a novel adhesive suture retention device

2. Improved perfusion versus suture alone

In this laser speckle contrast analysis (LASCA) perfusion image of a human excisional wound closure under tension (RED represents the highest perfusion; BLUE represents the lowest perfusion), there is higher perfusion with HEMIGARD® ARS and a standard suture (at left) versus a standard suture alone (at right). In a clinical study, there was a 25% improvement in perfusion versus suture alone.

Enhanced perfusion of elliptical wound closures using a novel adhesive suture retention device

3. Less skin tearing

Less wound edge stress translates into less skin tearing than with suture alone. In a fresh ex vivo human foot, HEMIGARD® ARS allowed 27% higher suture tension prior to skin tearing than suture alone.

Suture Pullout in Human Cadaveric Skin: Evaluation of HEMIGARD Augmentation Versus Suture Alone

4. Reduced postoperative dehiscence in lower extremity closures under tension

In a two-center clinical trial of excisional wound closures under tension, there was an 89% reduction in postoperative lower extremity wound dehiscence in wounds closed with HEMIGARD® ARS versus those closed with standard sutures alone.

Use of a Adhesive Suture Retention Device: A Retrospective Review

How is HEMIGARD^® ARS better than suturing through other retention tapes or film dressings?

Those materials may work well for select cases in which fragile wounds are closed under minimal tension. However, they may fail intraoperatively and postoperatively. They also lack the zonal advantages of the HEMIGARD^® ARS in providing a stiff, rip resistant advancing edge with stretchy trail edge to prevent blistering.

What minimum size of retention suture do you recommend?

At minimum, 2-0 nylon. We offer a custom 0 nylon with 24mm needle.