2017 NOV: A Novel Skin Closure Device for [Bilateral] Total Knee Arthroplasty: Randomized Controlled Trial vs. Staples
Poster Presentation: Benner RW, Behrens JP. “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.
Synopsis: Randomized, controlled, prospective study of 25 subjects that underwent simultaneous bilateral total knee arthroplasty (TKA), with Zip Surgical Skin Closure used to close one knee and surgical staples to close the other knee. Randomization was regarding which knee received the Zip device. Patient follow-up occurred at hospital discharge, two weeks and eight weeks post-operatively. This study was sponsored by ZipLine Medical, Inc.
- 72 percent of patients had greater range of motion on the Zip-closed knee (p = .002), with 44 percent of these patients demonstrating a more than five-degree difference between the Zip-closed and staple-closed knees
- Patients reported less pain on the Zip-closed knee vs. staples at discharge (p = 0.03), at 2-week follow-up (p= 0.03) and during device (Zip and staple) removal (p = 0.003)
- Both physicians and patients rated scar quality better on the Zip-closed knee
- 92 percent of patients indicated preference for the Zip in their next surgery
- Zip closure in knee replacement provided some clear benefits in our study,” said Dr. Benner. “Patients reported less pain, improved cosmetic outcomes, and even improved early function by improving range of motion. All in all, Zip closure improved the patient experience, and consequently, I have changed my practice to include Zip closure in all knee arthroplasties.”
Citation: Benner RW, Behrens JP. ” 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.
2017 OCT: Using a non-invasive secure skin closure following total knee arthroplasty leads to fewer wound complications and no patient home care visits compared to surgical staples. (The HSS study, published)
Peer-Reviewed Journal Publication in the October issue of The Knee Journal, https://www.ncbi.nlm.nih.gov/pubmed/28797879
Study Design: 221 prospective, consecutive subjects undergoing TKA received Zip closure. The results were compared to a (retrospective) cohort of 1001 subjects from the same surgeon who received staples for closure. Total number of subjects in the study n=1222. This was an independent study.
- The Zip patient group had a significantly higher BMI (p = 0.001), incidence of diabetes (p = 0.035) and smoking (p = 0.005).
- Zip patients removed dressings themselves (and therefore did not require a home health nurse visit) and did not report problems with dressing care.
- Rate of readmission for wound-related complications was significantly lower in the Zip closure group (p = 0.045). Overall readmission rates (all causes) were similar between groups.
- The Zip is easy to apply.
- Use of the Zip avoids a home care visit. In the bundled care environment, this can be a significant cost savings, and therefore should be of interest to the VAC.
- Use of the Zip produced fewer wound complications compared to staples.
- Results have been positive despite the study cohort having a higher number of diabetic patients and using an anticoagulant associated with a higher risk of wound complications.
Citation: Carli AV, Spiro S, Barlow BT, Haas SB. Using a non-invasive secure skin closure following total knee arthroplasty leads to fewer wound complications and no patient home care visits compared to surgical staples. Knee. 2017 Oct;24(5):1221-1226.
2017 SEP: Improvement in S-ICD Incision Closure Time and High Implanter Satisfaction Using a Novel Skin Closure Device
Podium Presentation: Presentation at Asia-Pacific Heart Rhythm Society Meeting, Sep 16, 2017 in Yokohama, Japan. Dan Goldman, MD from Boca Raton, FL presented. This study was not sponsored by ZipLine. This data was collected as part of a pilot program by Boston Scientific.
Study Design: 21 implanters/21 US sites/39 patients; Zip n=18, Suture n=21. This was an independent study.
- Zip was 4x faster than sutures, and saved an average of 7.5 minutes per procedure. This is a significant time savings for cath lab procedures.
- Closure time variability from case to case with sutures was 8 times higher than with Zip; less variability means more predictable closure times.
- Physician satisfaction was 3.9 out of 4.0, with 4.0 being most positive (based on application ease, speed, quality of closure and overall satisfaction).
- All physicians were “very likely” to use Zip again.
- Compared to sutures:
- 9/10 physicians said Zip is superior to sutures.
- 1/10 physicians said Zip is comparable to sutures.
Citation: Goldman DS, Hammill E, Aasbo J, Storne E, Reddy S. Improvement in S-ICD Incision Closure Time and High Implanter Satisfaction Using a Novel Skin Closure Device Scientific presentation given at Asia-Pacific Heart Rhythm Society 2017 Meeting; Sep 16, 2017; Yokohama, Japan.
2017 SEP: Zip Surgical Skin Closure Reduces Post-discharge Costs, Clinical Calls and Antibiotics in First Economic Study of Device. When Compared to Staples, Zip Cuts Post-Discharge Clinic Costs for Problem Patients, Wound Checks and Removal by 50 Percent
Podium Presentation: Emerson, Roger. ” Non-invasive, zip type skin closure device vs. conventional staples in total knee arthroplasty: Which method holds greater potential for bundled payments?” Scientific presentation given at The Knee Society 2017 Meeting; Sep 15, 2017; Naples, FL.
Synopsis: The study encompassed 130 consecutive TKA patients, with half of subjects closed with staples and half closed with Zip Surgical Skin Closure. All surgeries were performed at the Texas Center for Joint Replacement by the same surgeon using the same approach and implant, and were closed by the same surgical physician’s assistant. Patients were followed from surgery to first clinic post- operative visit (day 21-28) for assessment. This was an independent study.
- “In the study, we saw that staples and the Zip are both fast to apply in the operating room, but in the post-discharge environment, staple-related issues, such as patient phone calls, emergency department visits, infection concerns and removal create extra work and extra cost in the long run,” said Dr. Emerson. “In addition, patients were apprehensive about staple removal and concerned when they saw redness around their staples, which in some cases triggered antibiotic prescriptions to avoid possible infection.”
- The study findings showed that the Zip reduced all of the following measures when compared to staples:
- 46 percent reduction in incision-related actual clinic costs
- 60 percent reduction in incision-related clinic visits
- 75 percent reduction in incision-related antibiotics prescribed In addition, patients found the resulting scar from the Zip to be cosmetically more appealing, and the Zip device less painful to remove, than staples.
- “In addition to actual emergency room, clinic and wound-related care costs, which can be considered ‘bundle-busters’ in a bundled care setting, there are opportunity costs to consider, where unreimbursed time responding to patient calls, concerns and staple removal results in less time spent on billable activities,” said Omar Alnachoukati, director of clinical research at the Texas Center for Joint Replacement. “In the study, we found a five times higher opportunity cost in the staple group.” He continued, “Total joint arthroplasty is the largest expense for a single condition among Medicare beneficiaries, totaling $7 billion annually. With staples currently one of the primary methods currently used for TKA closure, this study suggests that replacing staples with the non-invasive Zip device has the potential to offer significant savings to the healthcare system.”
2017 JUN: Total Shoulder Arthroplasty- Excellent cosmesis, high patient satisfaction, reduced procedure time, zero reported complications
Online Journal Publication: Binkley M, Albrecht MJ, Srikumaran U. “Noninvasive device helps with elective, traumatic shoulder incision closure.” Orthopedics Today: Healio, June 2017, https://www.healio.com/orthopedics/shoulder-elbow/news/print/orthopedics-today/%7B71cda7ed-c14d-4898-bfc6-8f6a25bec230%7D/noninvasive-device-helps-with-elective-traumatic-shoulder-incision-closure. Accessed Aug 2, 2017.
Synopsis: Uncontrolled case series of 360 shoulder arthroplasty, biceps tenodesis, proximal humerus fractures and trauma cases without substantial soft tissue injury at Johns Hopkins University-affiliated hospital. This was an independent study.
- Traditional methods of skin closure can cause microtrauma to the epidermal skin and microvascular blood supply. Complications include wound dehiscence, infection, wound inflammation, discharge and drainage, abscess formation, skin edge necrosis and allergic reaction. Pain associated with suture and staple removal can make patients anxious and may lead to suboptimal patient satisfaction.
- On the Zip cases, no wound-related postoperative complications, no wound dehiscence, skin irritation or infection.
- Exclusive adjustable/reversible feature of the Zip allows in-situ correction of under- or over-tightening situations.
- Zip is current device of choice because of its ease of use, high degree of patient satisfaction, low complication rate, cosmesis of closure, speed of application and time savings during follow-up clinic visits.
2017 FEB: Total Ankle Arthroplasty- Zip Demonstrated Higher Tissue Perfusion vs. Staples
Poster Presentation: Davis A, Vaughn M, Piraino J. “Effect of Surgical Incision Closure Device on Skin Perfusion Following Total Ankle Arthroplasty.” Poster session presented at American College of Foot and Ankle Surgeons; Feb 27-Mar 1; Las Vegas, NV, http://www.acfas.org/Regional-Divisions/Div-5-Davis-2017/. Accessed Aug 2, 2017.
Synopsis: 9 patients underwent total ankle arthroplasty, 5 were closed with Zip, 4 with staples. Laser assisted indocyanine green angiography (LA-ICGA) was used to measure tissue perfusion pre- and post-operatively. This was an independent study.
- Zip demonstrated statistically significant higher blood perfusion than staples (decrease from baseline: Zip -21.6 ± 4.1% vs. staples -39.3 ± 4.3%, p<0.001.)
- Two staple patients had incisional dehiscence.
- Adequate perfusion is needed for tissue healing. Care needs to be taken in all steps of the surgical process to minimize incisional dehiscence and post-operative complications. Everything from patient selection to skin closure and post- operative dressings needs to be taken into careful consideration. New and emerging technologies can be used to the surgeon’s and patient’s advantage to obtain the best possible outcomes.
2017 FEB: Total Knee Arthroplasty- Zip demonstrated better cosmesis, less pain compared to staples
Peer-Reviewed Journal Publication: Ko, J. H., Yang, I. H., Ko, M. S., Kamolhuja, E. and Park, K. K. (2016), Do zip-type skin-closing devices show better wound status compared to conventional staple devices in total knee arthroplasty?. Int Wound J. doi:10.1111/iwj.12596
Synopsis: Department of Orthopaedic Surgery, Yonsei University, College of Medicine, Seoul, Korea. Randomized, Prospective, Controlled Study, Total Joint Arthroplasty, n= 90, staple control. Endpoints: pain, cosmesis, complications.
- Outcome: Cosmesis was significantly better with the Zip with data captured at POD 1, 3, 14 and 90 using the Vancouver scar score (VSS).
- Complications: There was no significant difference in wound complications between the two groups.
- Pain: The zip showed less pain on postoperative 14 day, especially during dressing and removal of the device
2017 JAN: Plastic and Reconstructive Surgery- Effect of Zip on reducing keloid and hypertrophic scar formation
Peer-Reviewed Journal Publication: 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. (English translation attached.)
Synopsis: Medical-Surgical Department of Wounds and Scarring, Burns, Plastic and Reconstructive Surgery, University Hospital Montpelier, France; Uncontrolled case series of 21 patients received the Zip after undergoing various reconstructive surgeries where a portion of tissue was removed, including scar resection, cancer, flap, burn sequela, pressure sore or re-closure of previous postoperative dehiscence. Zip device was removed after two weeks, and a new Zip was applied for an additional two weeks. This was again repeated an average of 3 times for an average total wear time of 42 days. Scars were evaluated by independent evaluators; results were considered positive if scars remained linear without secondary enlargement after 6 months. This was an independent study.
- Ogawa (Ogawa R, et. al. Wound Repair Regen. 2012; 10.1111/j.1524-475X.2012.00766.x) demonstrated that distraction forces on the wound increases synthesis of collagen in the scar and cause scar proliferation, hypertrophy and keloid formation. Furthermore, Levi (Levi K, et al. Cureus. 2016;doi:10.7759/cureus.827) demonstrated that the Zip’s uniform force distribution structure and resulting “isolation zone” immobilizes distraction forces more than staples or sutures.
- In this unique case, series use of the Zip for several weeks limits postoperative mechanical tension and minimizes scars, even in areas in tension and after keloid excision.
2016 OCT: Pediatric Cardiac Surgery- Zip was 2x faster, had fewer infections, less removal pain
Peer-Reviewed Journal Publication: Tanaka Y, Miyamoto T, Naito Y, Yoshitake S, Sasahara A, Miyaji K. Randomized Study of a New Noninvasive Skin Closure Device for Use After Congenital Heart Operations. Ann Thorac Surg. 2016 Oct;102(4):1368-74. doi:10.1016/j.athoracsur.2016.03.072. Epub 2016 Jun 1. PubMed PMID: 27261084.
Synopsis: Gunma Children’s Medical Center in Shibukawa, Japan Pediatric Cardiothoracic Surgery Randomized, Prospective, Controlled Study (Japan). Prospective, randomized, controlled study, n=214, suture control; patients undergoing cardiac operations through median sternotomy. Patient population: Age (months)- First operation group: 18.6+/-36.8 months old for Zip, 30+-45.9 months old for suture arms; Reoperation group: 30.5+/-45.9 months old for, 21.6+/-19.8 months old for suture arms. This was an independent study.
- Zip closure was 3.3x faster than sutures(113.0 +/- 9.1 seconds for Zip vs 375.9 +/- 60.2 seconds for sutures, p < 0.001).
- Variance in wound closure time with the Zip was considerably smaller compared to the suture closure time variance; this suggests not only a shorter, but a more predictable closure time for OR efficiency.
- Cosmetic appearance was significantly better in the Zip group.
- Fewer wound infections occurred in the Zip group (non-statistically significant).
- Zip patients showed less pain (crying out during removal) during removal of devices vs. stitches, (7.1% vs 52.5%, p < 0.001). This was considered a particularly beneficial feature for pediatric patients.
2016 OCT: Electrophysiology/Pacemaker- Zip was 3x faster, more predictable closure, similar cosmesis to subcuticular suture, less post-op pain
Peer-Reviewed Journal Publication: Lalani GG, Schricker AA, Salcedo J, Hebsur S, Hsu J, Feld G, Birgersdotter-Green U. Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device. Pacing Clin Electrophysiol. 2016 Oct;39(10):1077-1082. doi: 10.1111/pace.12926. Epub 2016 Sep 13. PubMed PMID:27470060.
Synopsis: University of California San Diego. Prospective, randomized, controlled study, n=40, suture control. Patient population: Age (years)- 71+/-14 for Zip group; 70+/-15 for Suture group.
- Zip was approximately 3 times faster than staples; Zip demonstrated 64% reduction in mean closure time per cm of incision length (18.0 +/-2.0 sec/cm for Zip vs. 50.1 +/- 16.7 sec/cm for suture)
- Zip had less variance in closure time with Zip (std. err. 2.08) vs. sutures (std. err. 6.72, p<0.001). Less variance means more predictable closure time.
- Zip had less post-operative patient-reported pain (NSS)
- Both groups had similar cosmetic outcome
- There was no difference in wound complications
2016 OCT: In-Vivo Animal Study on Mechanics of Wound Closure- Zip Isolation Zone protects incision from distraction forces better than staples and sutures
Peer-Reviewed Online Journal Publication: Levi K, Ichiryu K, Kefel P, et al. Mechanics of Wound Closure: Emerging Tape-Based Wound Closure Technology vs. Traditional Methods. Muacevic A, Adler JR, eds. Cureus. 2016;8(10):e827. doi:10.7759/cureus.827.
Synopsis: In-vivo animal study to measure the effect of the Zip’s force distribution and isolation zone on preventing distraction forces from reaching the incision. Incisions were closed with running subcuticular sutures, staples or Zip. Two experiements were performed: 1) skin on either side of the closed incision was stretched to strains of 5% and 10% and tissue strain was analyzed using Digital Image Correlation (DIC), and 2) distraction (i.e., “pulling apart”) force was applied and measured until the incision acutely dehisced by 1mm.
- The Zip showed better isolation from shear across the incision compared to staples and sutures, holding the wound intact better and keeping the force uniform along the incision. This would lead to better wound healing and reduced scarring.
- Staples demonstrated significant non-uniform shear strains which can lead to post-surgical scarring.
- Shear strains were lower with sutures compared to staples but higher compared to Zip. In 40% of the sites, sutures were unable to hold the wound intact during the experiment, leading to dehiscence.
- The holding strength difference between the Zip and staples was not statistically significant (p > 0.05); staples and Zip had a significantly higher holding strength with respect to sutures (p < 0.01). However, while the forces required to dehisce the stapled wound were relatively high, the staples were observed to pinch on the healthy skin tissue around the staples, leading to a strong inflammatory reaction.
- Note that the holding strength did not result in breakage of the sutures, staples or Zip. The dehiscence measured was a temporary gap in the incision induced by the distraction forces; once the force was released, the incision remained closed. The temporary gap illustrates how a wound is perturbed from normal patient movement during recovery that can impact healing and scar formation.
2016 AUG: Total Joint Arthroplasty- Use of Zip as part of “infection prevention kit” resulted in higher satisfaction with healing, no infections, hematomas or other complications
Poster Presentation: Insuasty M, Arbelaez W, Avendaño F, Guzman Melo L. “Experience with the use of “complementary infection prevention kit” in joint replacement surgery at the Central Military Hospital.” Poster session presented at 12th Annual ELCCR – Latin American Meeting of Hip and Knee Surgeons, August 3-6, 2016, Cartagena, Colombia. (translated from Spanish)
Synopsis: Central Military Hospital Bogota, New Granada Military University, Bogotá Colombia. Observational, descriptive, retrospective study of case series, patients undergoing primary replacement of the hip or knee in HOMIC from 7/1/2015 to 1/31/2016 using the “complementary CTP kit for prevention of infection ” composed of a topical hemostatic agent, a skin barrier (3M Cavilon), a system of atraumatic skin closure (ZipLine) and an antimicrobial occlusive dressing (PolyMem). 22 patients, 16 women, 6 men were evaluated. The average age was 61.5 years; average hospital stay was 3.9 days average 106 CC bleeding. This was an independent study.
- Satisfaction with the result of healing was much better or better than expected in 18 patients and much worse than expected in 3 patients.
- No infections, hematomas, or other complications.
- The use of the kit in this series showed little bleeding, no discharge or infection, excellent satisfaction in most patients. This kit is a good strategy to help minimize the risks associated with hip and knee arthroplasty and increase satisfaction with the outcome of patients.
2016 JAN: Dermatology- Melanoma Lesion Excision- Zip was 2x faster, produced less patient anxiety with similar cosmesis and complication rates compared to sutures
Peer-Reviewed Journal Publication: Mitwalli H, Dolan C, Bacigalupi R, Khorasani H. A randomized, controlled, prospective clinical study comparing a novel skin closure device to conventional suturing. J Am Acad Dermatol. 2016 Jan;74(1):173-4. doi:10.1016/j.jaad.2015.08.004. PubMed PMID: 26702797.
Synopsis: Department of Dermatology, Mount Sinai School of Medicine, New York, NY. Randomized, controlled prospective trial comparing the outcomes of the Zip to sutures in melanoma excisions; twenty patients (11 men and 9 women; mean age 51.17 years; range 24-71 years) with basal cell carcinoma, squamous cell carcinoma or dysplastic nevi of the trunk (n = 14) or extremities (n = 6); 17 patients completed all study end points, while 3 patients withdrew consent. This study was conducted using an early version of the Zip device (Zip 3).
- Zip was twice as fast as suture closure.
- Less apprehension: surgeons and staff noted that patients were exhibited less anxiety when the Zip was used (due to comfortable removal visit).
- No additional complications: no infections or other adverse effects with the Zip.
- Cosmetic outcomes: equivalent cosmetic results between the two methods.
- Conclusion: The Zipline system improved the efficiency of wound repair while producing aesthetically equivalent results to conventional epidermal suturing in the linear repair of trunk and extremity wounds following MMS or elliptical excisions. There was no increase in wound complications when using the device.
2015 AUG: Dermatology- Melanoma Lesion Excision- Zip was easy and fast to use with excellent cosmesis and patient satisfaction
Peer-Reviewed Journal Publication: Gorsulowsky D, Talmor G. A Novel Noninvasive Wound Closure Device as the Final Layer in Skin Closure. Derm Surg: August 2015 – Volume 41 – Issue 8 – p 987–989; doi: 10.1097/DSS.0000000000000399.
Synopsis: Uncontrolled, prospective case series. Objective: Examine the efficacy and practicality of this device for skin excision, rate ease of use and cosmesis. Methods:14 adult skin lesion excisions closed using Zip. Removal POD 10. Follow up at 2-3 months.
- Surgeons rated an average ease of application of 4.57/5 immediately after surgery.
- At POD10, surgeons reported an average Wound Evaluation Scale (WES) cosmesis score of 5.42/6, where 6 is best scar possible.
- Patients reported postoperative pain level of 1.46/10 (where 10 is highest pain imaginable) and an average pain level during device removal of 0.92/10.
- Surgeons scored the ease of removal of the device at an average of 4.09/5 where 5 is easiest possible.
- Adverse events were minimal, with no infections observed. One subject presented with very minor dehiscence because of postoperative trauma, and cosmetic/comfort outcomes were unaffected by this incident.
- Patient satisfaction was high, reporting an average satisfaction score of 3.43/4 where 4 is highest satisfaction.
- Cosmetic outcomes were evaluated during a second follow-up visit at 2 to 3 months post-op. Average VAS score was 83.48/100.
- Subjects reflected on their experience favorably, reporting an average comfort rating of 3.62/4 when the device was in place.
2015 AUG: Electrophysiology/Subcutaneous Implantable Cardioverter Defibrillator & Transvenous Implantable Cardioverter Defibrillator- Zip demonstrated ease of use, good cosmesis and ability to “rescue” a dehisced sutured wound
Peer-Reviewed Journal Publication: De Maria E. New skin closure system facilitates wound healing after cardiovascular implantable electronic device surgery. World J Clin Cases. 2015 Aug 16;3(8):675-7. doi: 10.12998/wjcc.v3.i8.675. PubMed PMID: 26301227; PubMed Central PMCID: PMC4539406.
Synopsis: a Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy. Case series shows two cases of ICD and S-ICD closure using the Zip 8 (older version); one case is a standard primary closure, the other is a “rescue” using the Zip on a 3-week-old incision that did not heal properly and was initially closed with subcuticular monocryl. This patient was an obese diabetic on hemodialysis.This was an independent study.
- The system is particularly useful when wound healing is difficult with traditional methods and in patients at high risk for surgical site infections (SSIs).
- This skin closure option is easy and quick to apply and remove, and produces excellent cosmetic results.
- Although it is associated with a minimal expense upcharge, the benefits, including the potential for decrease in SSI, make it attractive and worth considering for skin closure in device patients, particularly those at increased risk of complications.
- Case 1: Subcutaneous-implantable cardioverter defibrillator (S-ICD)] generator swap. Zip removed at POD14. Excellent results at 6mo follow up.
- Case 2: “Zip Rescue”: Obese diabetic on hemodialysis with incomplete wound healing from subcuticular suture skin closure at three weeks after a transvenous ICD implant: the skin remained partially “opened” after having used all “traditional” methods for closure, so a Zip device was placed as a “rescue”. Zip was removed 14 days later with excellent results.