Clinical Results 2018-04-20T01:59:27+00:00

Less Patient Pain

The pain associated with removal of staples and sutures can cause significant anxiety with patients.

In multiple studies, patients have reported the Zip to be substantially less painful to remove than staples1 or sutures2. Many physicians allow patients to remove the Zip at home, which can eliminate a clinic visit or home health nurse visit.

Greater Patient Satisfaction

A number of studies have shown that the Zip contributes to higher patient satisfaction compared to use of staples or sutures.3

Less Scarring

The Zip eliminates “track mark” scarring caused by staples and sutures, and several studies have demonstrated a superior aesthetic result.1 In addition, the Zip protects wounds from tension that can promote scar hypertrophy and keloid formation.1,2,6, 11-17

Greater Efficiency

Several studies have proven that the easy to use Zip is significantly faster than sutures to apply.4

Strong and Secure

The Zip has been shown to be 8x stronger than sutures in protecting the surgical incision from distraction forces.5 In a study of the biomechanics of wound closure the scaffold-like structure of the Zip demonstrated superior distribution of closing forces as well as protection from patient-induced forces in comparison to staples and sutures.6 The authors concluded that this would lead to better wound healing and reduced scarring.

Improved Tissue Perfusion

The Zip has been shown to have higher post-operative tissue perfusion compared to staples.7 In a foot and ankle study, the resulting tissue perfusion with the Zip was 50% higher in comparison to staples. Literature suggests that higher perfusion may lead to better healing and fewer wound complications.7

Reduced Hospital Costs9

The Zip provides an opportunity for hospitals to reduce their post-discharge costs, enhance patient satisfaction, avoid new channels for infection, and increase the efficiency of their OR.

In a bundled payment environment, hospitals are responsible for both in hospital costs and costs incurred during the 90-day post-discharge global period. This includes post-acute care, such as home health visits staple removal, and readmissions, which often occur due to infection. These costs can comprise approximately 50% of Medicare payments.

In an independent study of 1,200 TKA patients, patients with incisions closed with the Zip required no home health nurse visits that were otherwise required for staple removal.8

In the same study, none of the 223 patients closed with the Zip were readmitted for wound-related issues compared to 1.7% readmissions in the staple group.8

In a competitive hospital environment, the Zip can enhance patient satisfaction with their overall surgical experience. Studies have shown that the Zip results in less patient pain, fewer patient complaints, better scarring and greater patient satisfaction than staples.2, 10

REFERENCES
1. J.H. Ko et al., Do zip-type skin-closing devices show better wound status compared to conventional staple devices in total knee arthroplasty? Iwj.12596

2. Tanaka, Y. et al. Randomized Study of a New Noninvasive Skin Closure Device for Use After Congenital Heart Operations. Ann Thorac Surg 2016.

3. Data on file

4. Lalani, G. G., Schricker, A. A., Salcedo, J., Hebsur, S., HSU, J., Feld, G. and Birgersdotter-Green, U. (2016), Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device. Pacing and Clinical Electrophysiology. Accepted Author Manuscript. doi:10.1111/pace.12926

5. In an in-vivo study, more load in lb. was required to create 1 mm gap between incision edges approximated with Zip than Ethicon 4-0 Vicryl subcuticular running suture. Data on file.

6. Levi K, Ichiryu K, Kefel P, et al. (October 12, 2016) Mechanics of Wound Closure: Emerging Tape-Based Wound Closure Technology vs. Traditional Methods. Cureus 8(10); e827. DOI 10.7759/cureus.827.

7. Davis, A., et. al., Effect of Surgical Incision Closure Device on Skin Perfusion Following Total Ankle Arthroscopy, UF Health Poster Presentation at ACFAS, March 2017

8. Carli A., Haas SB. Novel Non-Invasive Secure Skin Closure Following Total Knee Arthroplasty: Fewer Wound Complications & No Patient Home Care Visits Compares to Staples, Paper presented at ISTA; 1 Oct 2015; Vienna, Austria.

9. Economic Value Analysis, MA0011 Rev E Data on file

10. Benner RW, Behrens JP. Poster Presentation: “A Novel Skin Closure Device for (Bilateral) Total Knee Arthroplasty: Randomized Controlled Trial vs. Staples.” Poster session presented at American Association of Hip and Knee Surgeons; Nov 3, 2017; Dallas, TX.

11. Téot L, Boissière F, Bekara F, Herlin C, Fluieraru S. ” Contrôle de la tension des berges cicatricielles après résection cutanée : un nouveau dispositif médical adhésif réglable. [Control of the skin edge tension after resection: a new adjustable, adhesive medical device.]” Revue Francophone de Cicatrisation. Volume 1, Issue 1, 2017, Pages 46-50.

12. Harn HI-C, Ogawa R, Hsu C-K, Hughes MW, Tang M-J, Chuong C-M. The tension biology of wound healing. Exp Dermatol. 2017;00:1–8.

13. Ogawa R, Koai K, Tokumura F, Mori K, Ohmori Y, Huang C, Hyakusoku H, Akaishi S. The relationship between skin stretching/contraction and pathologic scarring: The important role of mechanical forces in keloid generation.  Wound Rep Reg (2012) 20 149–157.

14. Ogawa R. Mechanobiology of scarring. Wound Rep Reg (2011) 19 S2–S9.

15. Son D, Harijan A. Overview of Surgical Scar Prevention and Management. J Korean Med Sci 2014; 29: 751-757.

16. Suarez E, Syed F, Rasgado T, Walmsley A, Mandal P, Bayat A. Skin equivalent tensional force alters keloid fibroblast behavior and phenotype. Wound Rep Reg (2014) 22 557–568.

17. Suarez, Edna M.Sc.; Syed, Farhatullah Ph.D.; Alonso-Rasgado, Teresa Ph.D.; Mandal, Parthasarathi Ph.D.; Bayat, Ardeshir M.B., B.S., Ph.D. Up-Regulation of Tension-Related Proteins in Keloids: Knockdown of Hsp27, [alpha]2[beta]1-Integrin, and PAI-2 Shows Convincing Reduction of Extracellular Matrix Production. Plastic and Reconstructive Surgery. Volume 131(2), February 2013, p 158e–173e.