SUTUREGARD® Provider FAQ's

SUTUREGARD®
Provider FAQ's

PROBLEM:

Time and resource intensive wound closure, such as skin flaps, skin grafts, and second intent healing.

SOLUTION:

Faster and less complex repairs of wounds up to 3cm wide. Most cases avoid skin flaps and grafts, resulting in a linear closure. This helps retain more patients in the office setting.

MECHANISMS OF ACTION:

SUTUREGARD® ISR device is a bridge for suture that facilitates stress-relaxation (skin stretch and reduced tension) of surgical wounds. Alone, a high-tension retention suture will crush the skin. As shown at right, the SUTUREGARD® ISR Device not only reduces the pressure of the suture but also displaces that pressure away from the wound edge (i.e. SUTUREGARD® left; suture-alone right).

In a clinical trial of closure of Mohs scalp defects with no undermining, 30 minutes of stress-relaxation with the SUTUREGARD® ISR device resulted in 65% lower wound closure tension.i Extensive undermining involves a reduction of perfusion to the wound edges and creation of a third space.ii Preclinical trials have demonstrated that stress-relaxation of wounds results in twice the reduction of wound closure tension compared with extensive (greater than width of wound) undermining with fewer complications (e.g. hematoma, wound dehiscence).iii

COMMON BODY SITES:

Sites must have adequate skin strength to withstand the pressure of the SUTUREGARD® ISR:

• Scalp
• Forehead/Temple
• Shoulder/Trunk
• Leg
• Foot/Ankle

An ideal situation for SUTUREGARD® ISR is while waiting for frozen section pathology during cancer removal (e.g. Mohs surgery). The devices can be used to approximate and stretch skin while awaiting results.

Suture

Large bite (10mm) suture. We recommend SUTUREGARD® ISR Retention Suture Device custom USP 0 suture.

Thread

Remove suture needle and insert ends of suture through slots of bridge and washer.

Relax

Apply tension to suture and clamp or knot.

Finish Closure

Place additional wound closures supports (e.g. sutures, staples).

WHY NOT JUST USE A PULLEY (“far-near-near-far”) SUTURE?

Pulley sutures place most of the wound closure force on the “near-near” segment that traverses the wound edge. If desired, the pulley suture pattern (far-near-near-far) can be performed with a SUTUREGARD® ISR to protect the wound edges.iv

Also, unlike a “pulley” suture, the SUTUREGARD® ISR allows for easy and rapid readjustment of suture tension with a simple surgical hemostat.

WHY NOT JUST USE A TOWEL CLAMP?

Towel clamps were not designed to pierce human skin. In a clinical trial on ex vivo human skin, we found that the force required for a towel clamp to pierce human skin was over EIGHT times that of a surgical needle.v The force required to pierce skin with a towel clamp is both damaging to skin and disturbing to awake patients.

WHY NOT USE OTHER COMMERCIALLY AVAILABLE SUTURE RETENTION DEVICES?

The use of a SUTUREGARD® ISR device requires fewer skin punctures and much less time than competing devices, and costs significantly less.vi

i Lear, W., Blattner, C., Mustoe, T., Kruzic, K. (2019). In vivo stress relaxation of human scalp. Journal of the Mechanical Behavior of Biomedical Materials, (97), 85-89.

ii Morris, S et al. The Anatomic Basis for Perforator Flaps. Clin Plas Surg 37(4), 553-570, 2010

iii Melis, P et al Tension decrease during skin stretching in undermined versus not undermined skin: an experimental study in piglets. Plast Reconstr Surg. 2001 Apr 15;107(5):1201-5; discussion 1206-7.

iv Ferrell, K., Fancher, W., & Lear, W. (2019). Surgical Pearl: Use of a novel suture retention device to protect skin edges while using pulley suture technique for high tension wound closure. JAAD Case Reports.

v Data on file

vi Stoecker, A. Howerter, S., Young, J., & Lear, W. (2018). The use of a suture retention device with punctureless technique for rapid tissue expansion in facial and lower extremity wounds. JAAD Case Reports, 4(9), 910-914.