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Wound Closure

DERMABOND PRINEO® Skin Closure System

DERMABOND PRINEO® Skin Closure System

DERMABOND PRINEO® Skin Closure System

DERMABOND PRINEO® Skin Closure System

Overview

Secure skin closure is an integral step of nearly every surgical procedure. If the closure device does not provide the strength and support required by the skin tissue, the wound edges may separate, providing a potential pathway for bacterial contamination, which can lead to infection, suboptimal cosmesis, and low patient satisfaction.1,170,171

Longer incisions present unique clinical challenges, such as approximating wound edges evenly, distributing tension evenly across the wound, and maintaining the integrity of the surgical site.

DERMABOND PRINEO System is a unique two-part skin closure system consisting of:

  • A 2-octyl cyanoacrylate topical skin adhesive for proven strength and microbial protection in vitro1
  • A flexible, self-adhesive polyester mesh for excellent approximation and healing1

DERMABOND PRINEO System can add strength and protection when closing medium to long incisions.

Strong:

  • DERMABOND PRINEO System can replace use of subcuticular sutures for skin closure.* It has tissue holding strength equivalent to 3-0 MONOCRYL® (poliglecaprone 25) Sutures (shown ex-vivo)1
  • DERMABOND PRINEO System was shown to provide statistically significant greater skin holding strength than skin staples or subcuticular suture

Protective:

  • Provides a flexible microbial barrier with 99% protection in vitro for 72 hours against organisms commonly responsible for surgical site infections (SSIs)117,‡
  • DERMABOND PRINEO System demonstrated in vitro inhibition of gram positive (MRSA and MRSE) and gram negative bacteria (E. coli)§

Efficient:

  • May reduce final layer of skin closure time up to 75%1

DERMABOND PRINEO System is part of the DERMABOND® Portfolio. Each product in the DERMABOND Portfolio provides strong, protective, and efficient closure.1,117,192,193

The products in the DERMABOND Portfolio are supported by more clinical evidence, outcomes data, and publications than any other Topical Skin Adhesive.1

Site References

  • * except in patients with skin which may be regularly exposed to body fluids, with dense natural hair (e.g., scalp) or with a known hypersensitivity to cyanoacrylate, formaldehyde, or pressure sensitive adhesive
  • In an ex vivo study, more load in N was required to create 3 ± 1 mm gap between skin edges approximated with DERMABOND PRINEO System, than with subcuticular 3-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo Surgery skin staples (p=0.00)
  • Staphylococcus epidermidis, Staphylococcus aureus, Escherichia coli, Enterococcus faecium, Pseudomonas aeruginosa
  • § Clinical significance is unknown1
Description & Specs

DERMABOND PRINEO System is an innovative, two-part system for uncompromised strength and healing.1,202

Applicator and liquid adhesive

  • A 2-octyl cyanoacrylate topical skin adhesive provides strength and microbial protection in vitro1,202
  • Sets in approximately 60 seconds when applied to mesh tape
  • Before contacting the mesh tape, the adhesive has a 2-hour working time1

Polyester mesh tape

  • A flexible, self-adhesive polyester mesh tape in combination with the liquid adhesive provides excellent approximation and healing1
  • Contains an initiator to accelerate the polymerization of the liquid adhesive
  • Each dispenser contains 60 cm of mesh tape

DERMABOND PRINEO System enhances comfort and convenience for patients

  • No need for post-surgical dressings may mean easier self-care
  • If directed by the health care practitioner, patients are able to shower immediately following the procedure.
  • Mesh tape removes easily when wound is sufficiently healed1

DERMABOND PRINEO System can be used as an alternative to subcuticular sutures when closing medium to long incisions1

PRODUCT CODE DESCRIPTION MESH LENGTH EA/BX
CLR602US 2-octylcyanoacrylate topical skin adhesive applicator. Flexible, self-adhesive polyester mesh tape dispenser 60 cm 2
Videos & Media

DERMABOND PRINEO® Skin Closure System Technique Video (2 min 3 sec)

DERMABOND PRINEO® Skin Closure System application technique video.

Science & Technology

Secure skin closure is an integral step of nearly every surgical procedure. If the closure device does not provide the strength and support required by the skin tissue, the wound edges may separate, providing a potential pathway for bacterial contamination, which can lead to infection, suboptimal cosmesis, and low patient satisfaction.1,170,171

Excellent outcomes can be achieved if a skin closure device:

  • Provides the strength to maintain skin edges so that they remain approximated and level
  • Distributes tension along the entire incision, adding uniform strength to the incision and preventing skin gaps from forming when the skin is stressed
  • Creates a strong, flexible barrier to prevent bacteria from entering the incision until the epidermis has fully healed

Longer incisions present unique clinical challenges, such as approximating wound edges evenly, distributing tension evenly across the wound, and maintaining the integrity of the surgical site.

DERMABOND PRINEO System is a unique two-part system that consists of a liquid adhesive and a polyester mesh.

  • The liquid adhesive contains a highly purified 2-octylcyanoacrylate monomer, which, after polymerization is stronger, more flexible, and less brittle than other cyanoacrylates.1 Furthermore, the adhesive's formulation includes proprietary additives to enhance strength, flexibility, and adherence to the skin1
  • The polyester mesh facilitates wound edge approximation and contains a chemical initiator to ensure consistent, reliable polymerization times1

The benefits of DERMABOND PRINEO System are supported by pre-clinical and clinical data.1

Strong

DERMABOND PRINEO System was shown to provide statistically significant greater skin holding strength than skin staples or subcuticular suture.*

Comparison of holding strength for different Skin Closure techniques

Protection

Provides a flexible protective barrier that:

  • Conforms to the body’s contours and remains secure and in place1
  • Demonstrated in vitro inhibition of gram positive (MRSA and MRSE) and gram negative bacteria (E. coli)
  • Proven 99% effective through 72 hours in vitro against bacteria commonly associated with surgical site infection, including:1
    • Pseudomonas aeruginosa
    • Escherichia coli
    • Enterococcus faecium
    • Staphylococcus aureus
    • Staphylococcus epidermidis

Efficient

DERMABOND PRINEO System may reduce final layer of skin closure time up to 75%1

DERMABOND PRINEO System was compared to subcuticular sutures in a randomized, controlled, multicenter trial of patients (n=83) undergoing abdominoplasty or body lift procedures requiring incisions ≥ 20cm. Patients were randomized for final closure on half the incision using sutures and the other half using DERMABOND PRINEO System.1

Results:1
  DERMABOND PRINEO System Subcuticular sutures Statistical significance
Mean time for closure 1.46 min 6.65 min P<0.0001

A significant reduction in final skin closure was also seen in a second clinical study (n=79) where breast incisions ≥ 15 cm were closed using either DERMABOND PRINEO System or subcuticular sutures1

Results:1
  DERMABOND PRINEO System Subcuticular sutures Statistical significance
Mean time for closure 2.56 min 16.22 min P<0.0001

Cosmesis

DERMABOND PRINEO System provides excellent cosmetic results comparable to sutures1

15 days post-surgery

Cosmetic results similar to sutures at 90 days...214

As rated on the modified Hollander Cosmesis Scale, there were no significant differences between DERMABOND PRINEO System and sutures for any parameters evaluated, including:214

  • Step-off border
  • Contour irregularities
  • Wound margin separation
  • Edge inversion
  • Excessive inflammation
  • Overall appearance

...and through the 1-year follow-up period214

In patients followed for 1 year (n=50), there were no significant differences between DERMABOND PRINEO System and sutures for any parameters at 90 days, 6 months, or 1 year214

Site References

  • * In an ex vivo study, more load in N was required to create 3 ± 1 mm gap between skin edges approximated with DERMABOND PRINEO System, than with subcuticular 3-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo Surgery skin staples (p=0.00)1
  • Clinical significance is unknown1