DERMABOND PRINEO SKIN CLOSURE SYSTEM (22 CM)

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SKIN CLOSURE SYSTEM (22 CM) Evidence Brief: Comparative Wound Holding Strength and Tension Redistribution Introduction The is a non-invasive skin closure device that can be used to approximate the

It is intended to provide healthcare practitioners with additional information to enable an evaluation of the.

1 SKIN CLOSURE SYSTEM (22 CM) Evidence Brief: Comparative Wound Holding Strength and Tension Redistribution Introduction The is a non-invasive skin closure device that can be used to approximate the skin edges of medium-length surgical incisions evidence on the technical performance associated with the DERMABOND PRINEO. It is intended to provide healthcare practitioners with additional information to enable an evaluation of the. Product Description The Skin Closure System is the only skin closure system that combines the benefits of a proven topical skin adhesive with a flexible, self-adhering mesh. The Skin Closure System provides additional strength plus a microbial barrier to provide added security in wound closure. It redistributes tension across an incision to the surrounding healthy surface area and requires only topical application with no piercing of the skin. 1 Specifically, the DERMABOND PRINEO Skin Closure System has: Fast-setting 2-octyl cyanoacrylate topical skin adhesive that sets in approximately 60 seconds when applied to mesh. The topical skin adhesive uses a patented, proprietary chemical formulation that provides proven strength. 2-4 Provides a flexible microbial barrier with 99% protection in-vitro for 72 hours against organisms commonly responsible for SSIs 5* Skin Closure System demonstrated in vitro inhibition of gram positive (MRSA and MRSE) and gram negative bacteria(e coli) 6** Flexible, self-adhering polyester mesh is applied to provide alignment of the skin edges during application of the liquid adhesive. 7 Furthermore, the Skin Closure System has benefits that can enhance patient comfort, including: Cosmetic results similar to sutures with comparable cosmesis scores at 90- days through 1 year 8 The ability of patients to shower immediately after the procedure if directed by their healthcare practitioner 7 Easy mesh tape removal when the wound is sufficiently healed 9 For Illustrative purposes only *Staphylococcus epidermidis/e coli/s aureus/pseudomonas aeruginosa /Enterococcus faecium. **Clinical significance is unknown.

SKIN CLOSURE SYSTEM (22 CM) HAS GREATER SKIN-HOLDING STRENGTH TO STAPLES OR SUBCUTICULAR SUTURES 10, * This study examined the tissue-holding strength of Skin Closure System (22 cm) when compared

12 In a simulated layered closure, incisions in porcine skin samples were closed with interrupted, deep dermal, Coated VICRYL (polyglactin 910) Suture (size 3-0), and then the skin was closed with

2 SKIN CLOSURE SYSTEM (22 CM) HAS GREATER SKIN-HOLDING STRENGTH TO STAPLES OR SUBCUTICULAR SUTURES 10, * This study examined the tissue-holding strength of Skin Closure System (22 cm) when compared with staples or sutures. 11 Specifically, the study focused on the amount of force needed to create a 3-mm gap, considered to be a clinical failure in wound closure. 12 In a simulated layered closure, incisions in porcine skin samples were closed with interrupted, deep dermal, Coated VICRYL (polyglactin 910) Suture (size 3-0), and then the skin was closed with one of the following: A. B. C. Figure 1. Representative images of tensile mechanical testing of porcine skin samples closed with (A), (B) subcuticular sutures, or (C) surgical staples.. (n=16 samples) Surgical staples (35W) (n=16 samples) Subcuticular MONOCRYL (poliglecaprone 25) Suture (continuous, size 4-0) (n=16 samples) Samples were loaded into an Instron testing machine and mechanically pulled apart to determine the maximum tensile load needed to create a 3-mm (± 1 mm) gap at the wound site. This gap represented clinical failure, irrespective of suture or staple pull-out. Mean max load (N) prior to 3-mm gap ( 1 mm) Comparative skin holding strengths Skin staples 4-0 subcuticular suture Figure 2. Tensile load needed to achieve a 3-mm gap in porcine samples closed with, surgical staples, or subcuticular sutures. Incisions closed with required significantly greater loads to create a 3-mm gap. Conclusions Incisions closed with were: 33% stronger when compared with the average strength of staples 40% stronger when compared with the average strength of 4-0 suture 11, ** Study performed ex-vivo* These results demonstrate that in a porcine model that simulates layered skin closure, wounds closed with Skin Closure System require significantly greater force to create wound separation. *In an ex-vivo study, more load in N was required to create a 3±1 mm gap between skin edges approximated with Skin Closure System, than with 11

3 SKIN CLOSURE SYSTEM (22 CM) HAS STRONGER ON AVERAGE SKIN-HOLDING STRENGTH THAN DERMABOND ADVANCED TOPICAL SKIN ADHESIVE COMBINED WITH SUBCUTICULAR SUTURES 10, * This study evaluated the maximum skin-holding strength of the in comparison to DERMABOND ADVANCED Topical Skin Adhesive with or without subcuticular sutures. 13 To determine the maximum skin-holding strength, incisions in porcine skin samples were closed with: (n=30 samples) DERMABOND ADVANCED Adhesive with subcuticular sutures (MONOCRYL Suture, continuous size 4-0) (n=30 samples) DERMABOND ADVANCED Adhesive alone (n=30 samples) Samples were then mechanically tested in tension until complete wound separation occurred Plot of tissue-holding strength Force (lb) DERMABOND ADVANCED w/ subcuticular sutures DERMABOND ADVANCED alone Figure 3. The maximum force until failure for incisions closed with and DERMABOND ADVANCED Adhesive, with or without subcuticular sutures. Incisions closed with Skin Closure System (22 cm) required greater force to create wound separation. Conclusions DERMABOND TM PRINEO was ~32% stronger on average than DERMABOND ADVANCED Topical Skin Adhesive combined with subcuticular 4-0 MONOCRYL (poliglecaprone 25) sutures. 13. ** *In an ex-vivo study, more load in N was required to create a 3±1 mm gap between skin edges approximated with Skin Closure System, than with

SKIN CLOSURE SYSTEM (22 CM) PROVIDES A MORE UNIFORM DISTRIBUTION OF TENSION COMPARED TO INCISIONS CLOSED WITH STAPLES AND SUTURES14* This study sought

samples) Subcuticular MONOCRYL Suture (continuous, size 3-0) (n=3 samples) Surgical staples (35R) (n=3 samples) Specimens were spray-painted with

Samples were video recorded during testing, and images were processed via digital image correlation to determine the strain of the sample.

Mapping of tissue movement under 1 lb of tensile load 14 Undesired stress concentrations Study performed ex-vivo* More Tissue Movement Intact incision

Visual maps of tension across the incisions revealed the following: Incisions closed with sutures and staples had high concentration points of tension

4 SKIN CLOSURE SYSTEM (22 CM) PROVIDES A MORE UNIFORM DISTRIBUTION OF TENSION COMPARED TO INCISIONS CLOSED WITH STAPLES AND SUTURES14* This study sought to elucidate the distribution of tension across incisions closed with the Skin Closure System (22 cm) in reference to incisions closed with surgical staples and subcuticular sutures.15 To study the distribution of tension on an incision subjected to tensile loading, porcine skin samples were closed with: System (22 cm) (n=4 samples) Subcuticular MONOCRYL Suture (continuous, size 3-0) (n=3 samples) Surgical staples (35R) (n=3 samples) Specimens were spray-painted with black-and-white speckles and then loaded under tension at 1, 5, 10, 15, and 20 lb of force. Samples were video recorded during testing, and images were processed via digital image correlation to determine the strain of the sample. The strain map could then be studied to determine the distribution of tension across the incisions closed with each tested method. Mapping of tissue movement under 1 lb of tensile load 14 Undesired stress concentrations Study performed ex-vivo* More Tissue Movement Intact incision line Too much movement near incision Undesired stress concentrated far from incision Intact incision line Less Tissue Movement 3-0 Suture Skin Staple Visual maps of tension across the incisions revealed the following: Incisions closed with sutures and staples had high concentration points of tension (stress risers). Incisions closed with had a more uniform distribution of tension compared to incisions closed with staples and sutures (3-0 MONOCRYL (-poliglecaprone 25)14, ** Conclusion closes incisions with an even distribution of tension *In an ex-vivo study, more load in N was required to create a 3±1 mm gap between skin edges approximated with Skin Closure System, than with

5 References: 1. EMEA claims matrix van Nooten F, De Cock E, Fagre J, Tan R. Comparing time and supplies usage associated with a new skin closure device vs. standard of care wound closure for abdominoplasty surgery in The Netherlands. Paper presented at: International Society for Pharmacoeconomics and Outcomes Research, 11th Annual European Congress, 2008; Athens, Greece. 3. Richter D, Stoff A, Ramakrishnan V, Exner K, Jernbeck J, Blondeel PN. A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. Plast Reconstr Surg. 2012;130(4): Blondeel PN, Richter D, Stoff A, Exner K, Jernbeck J, Ramakrishnan V. Evaluation of a new skin closure device in surgical incisions associated with breast procedures. Ann Plast Surg. 2013; e-publication ahead of print. 5. Ethicon, 06TR071 [Study Report for in vitro evaluation of microbial barrier properties of DERMABOND ProTape ], December 2006, Data on File. 6. Ethicon, Notebook 4203:96-100, [In-vitro study to evaluate the ability of PRINEO Skin Closure System to kill bacteria on contact ] June 2012, Data on File. 7. Ethicon I. Skin Closure System (22 cm) Instructions for Use. LAB Ethicon, 06CS005, [Multi-centre study to show equivalence of DERMABOND PROTAPE to INTRADERMAL SUTURES for skin closure of full thickness surgical incisions], June 2010, Data on File. 9. Data on File, Ethicon, Inc.: Dirk Richter Letter Easily removed 05/21/ Ethicon, AST , [Study to Compare the tissue holding strength of PRINEO skin closure system with conventional wound closure techniques], October 2012, Data on File. 11. Ethicon, AST , [Study to compare the tissue holding strength of 22 cm Skin Closure System (DP22) to conventional wound closure techniques ], September 2014, Data on File. 12. Lo IK, Burkhart SS, Chan KC, Athanasiou K. Arthroscopic knots: determining the optimal balance of loop security and knot security. Arthroscopy. 2004;20(5): Ethicon, [Report of study comparing tissue holding strength of Skin Closure System 22 cm (DP22) to DERMABOND ADVANCED TM with and without Subcuticular Sutures], August 2014, Data on File. 14. Ethicon, [Report for mapping strains in Skin Closure System 22 cm (DP22) Comparative Study], August 2014, Data on File. 15. Data on File, Ethicon, Inc.: Report for mapping strains in Skin Closure System 22 cm (DP22) Comparative Study. Please always refer to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions. Ethicon Endo-Surgery (Europe) GmbH Hummelsbütteler Steindamm Norderstedt, Germany Ethicon Endo-Surgery (Europe) GmbH EMEA

micromend Skin Closure Device Pre-clinical Studies of Closure of Surgical Wounds in Live Pigs

micromend Skin Closure Device Pre-clinical Studies of Closure of Surgical Wounds in Live Pigs RONALD BERENSON, M.D. and PAUL LEUNG, M.S. EXECUTIVE SUMMARY KitoTech Medical has developed a revolutionary