Port-Site Closure

Patient satisfaction

• Patient may be able to shower immediately after the procedure, if directed by the healthcare professional1

• At the time of removal, DERMABOND PRINEO System is associated with less pain than other wound closure devices2

• No post-surgical dressings may mean easier self-care and greater self-confidence for patients3

• Results in excellent cosmesis4

Protection and strength

• Provides microbial-barrier protection 99% e�ective in vitro for 72 hours against organisms commonly responsible for surgical site infection (SSI)5*– Demonstrated in vitro inhibition of Methicillin-resistant Staphylococcus aureus, Methicillin-resistant Staphylococcus

epidermidis, and Escherichia coli †

• Powerful combination of topical skin adhesive and self-adhering mesh, provides significantly greater skin-holding strength than skin staples, subcuticular suture,6,7‡ or DERMABOND ADVANCED® Topical Skin Adhesive8§

DERMABOND® PRINEO® Skin Closure System (22 cm)

As a replacement for sutures or staples, DERMABOND PRINEO System provides minimally invasive closure — no holes in the skin, no sutures or staples1

Device can be cut to size of port-site wounds

*Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Enterococcus faecium

†Clinical significance unknown

‡In an ex vivo study, more load in N was required to create a 3-mm gap between skin edges approximated with DERMABOND PRINEO System (22 cm) than with subcuticular 4-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo-Surgery skin staples (P<.001).

§Study performed ex vivo.

2. Remove mesh from mesh carrier. Using sterile scissors, trim mesh patch to length ensuring that 1 cm of mesh extends past both ends of the incision.

Do not discard the unused portion of the mesh as it will be used to close additional port sites.

3. Remove the center paper backing on the mesh. Apply the mesh, pressing gently to ensure intimate contact with the selected side of the incision.

4. Gently pull the mesh perpendicularly over the incision while adjusting with fingers to achieve approximation and a�ix the remainder of the mesh to the other side of incision; remove both paper backings/frames.

Application highlights below. For complete product details see Instructions for Use.

5. Spread liquid adhesive smoothly and evenly over the entire surface of mesh tape and surrounding skin area.

Do not apply a second coat.

6. After about 60 seconds, check that the polymerization process is complete by gently dabbing along the incision with a gloved finger.

When no liquid or tackiness is apparent, the polymerization process is complete and the site is closed and sealed.

Repeat Steps 1-6 for each additional port site using the remainder of the mesh patch.

1. Prepare port sites for closure as per product IFU.

Verify that incisions are clean, dry, and hemostatic. Close deep layers such that there is no tension on the skin edges. The skin edges must be closely approximated prior to application of the mesh, such that significant manual approximation is not required during mesh application.

References: 1. DERMABOND™ PRINEO™ Skin Closure System Instructions for Use. Ethicon, Inc. 2. Parvizi D, Friedl H, Schintler MV, et al. Use of 2-Octyl Cyanoacrylate Together with a Self-Adhering Mesh (Dermabond™ Prineo™) for Skin Closure Following Abdominoplasty: An Open, Prospective, Controlled, Randomized Clinical Study. Aesth Plast Surg. 2013;37:529-537. 3. De Cock E, F, Mueller K, Tan R. Changing the surgical wound closure management pathway: time and supplies with PRINEO vs. standard of care for abdominoplasy surgery in Germany. Poster presented at: International Society for Pharmaocoeconomics and Outcomes Research, 11th Annual European Congress: November 2008; Athens, Greece. 4. 06CS005 Multi-centre study to show equivalence of DERMABOND PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions. Final Report 10 June 2010. Ethicon, Inc. 5. Su 06TR071 Study Report for in vitro evaluation of microbial barrier properties of DERMABOND ProTape. Ethicon, Inc. 6. Kumar A. AST-2014-0246. Ethicon, Inc. Study to compare the tissue holding strength of DERMABOND® PRINEO® 22 cm Skin Closure System (DP22) to conventional wound closure techniques. Ethicon, Inc. 7. Kumar A. AST-2012-0290. Completion Report: Study to compare the tissue holding strength of PRINEO Skin Closure System with conventional wound closure techniques. 2012. Ethicon, Inc. 8. Report of study comparing tissue holding strength of DERMABOND®PRINEO® Skin Closure System 22 cm (DP22) to DERMABOND ADVANCED® with and without Subcuticular Sutures. 100253930. Ethicon, Inc.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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