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™ Skin Closure 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™ are supported by pre-clinical and clinical data.1
Strong
DERMABOND™ PRINEO™ was shown to provide statistically significant greater skin holding strength than skin staples or subcuticular suture.*
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™ may reduce final layer of skin closure time up to 75%1
DERMABOND™ PRINEO™ 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™.1
| Results:1 |
| |
DERMABOND™ PRINEO™ |
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™ or subcuticular sutures1
| Results:1 |
| |
DERMABOND™ PRINEO™ |
Subcuticular sutures |
Statistical significance |
| Mean time for closure |
2.56 min |
16.22 min |
P<0.0001 |
Cosmesis
DERMABOND™ PRINEO™ 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™ 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™ 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™ Skin Closure 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