Use of a non-invasive surgical skin closure device in dogs following dorsolateral hemilaminectomy

Abstract

The ZipLine 16 surgical skin closure device (ZipLine 16; Zipline Medical, Campbell, California, USA) provides noninvasive surgical wound closure. This prospective study investigated its use in dogs undergoing a dorsolateral hemilaminectomy. Although the device produced normal appositional healing compared with controls, unacceptable traumatic dermatitis that is likely related to the device adhesive was noted after removal.

The ideal wound closure device would be easy to use, painless to the patient, rapidly applied, have a low rate of dehiscence, and be inexpensive (1). One of the most common methods of skin closure for surgical incisions or traumatic wounds is the use of sutures, which is advantageous because of frequent use by surgeons, low rate of dehiscence, good tensile strength, availability, and low cost (2). Skin sutures, however, are variably associated with pain, infection, dehiscence, and allergic reactions. Additional skin closure techniques used in veterinary medicine include skin staples and “tissue glue” or cyanoacrylates, which are chemicals that form an adhesive bond after contact with moisture. Staples can be applied quickly and easily, which may lower surgical costs through decreased anesthetic and operating room time. They produce less tissue reaction than suture, but there are conflicting data on infection rates compared to dermal and subcuticular sutures (3–5). Increased local tissue oxygenation was reported when compared to subcuticular suture (6). The advantages of using staples are balanced with the disadvantages of possible pressure necrosis if placed too deep or in the event of tissue swelling. This closure technique is also reported to cause more pain at the time of removal compared with suture removal (2). Additionally, staples require a specific instrument to facilitate appropriate removal. Tissue glue requires little operator skill, is subjectively less painful as the skin is not penetrated, and no removal is required. Recent investigations suggest that cyanoacrylates have benefits in wound closure and possess antimicrobial properties (7). However, such products may cost more than suture, have been associated with foreign body reactions in some humans (8), and are inadequate in the closure of wounds that are under high tension or are in areas of repetitive movement (2).

The ZipLine 16 surgical skin closure device (ZipLine 16; Zipline Medical, Campbell, California, USA; Figure 1) is a proprietary apparatus that provides noninvasive surgical wound closure, with approval for application in humans. It is designed to provide a suture-like closure in less time than traditional sutures, and with reduced skin irritation, inflammation, and discomfort. No serious adverse effects have been reported in humans on whom the device has been placed (9–11). The device holds potential for use in traumatic laceration wound management in which the speed of application and lack of dermal penetration are potentially advantageous and could be helpful for reducing the duration of anesthesia. It is currently used and licensed in human medicine, but its use in veterinary medicine has not been studied. The present randomized controlled trial was designed to assess the ZipLine 16 (Zipline Medical) surgical skin closure device in dogs undergoing a dorsolateral hemilaminectomy compared with surgical staples or suture.

Figure 1.

a, b — Zipline device; c — Zipline device on Dog #3 immediately after placement.

The dogs recruited for this study were presented to the emergency service of an academic referral hospital for neurologic signs of ambulatory or non-ambulatory paraparesis, or paraplegia, with a neurolocalization consistent with a T3–L3 myelopathy. Additional inclusion criteria included a clinical suspicion of intervertebral disc extrusion, with subsequent confirmatory cross-sectional imaging and spinal decompressive surgery. Owners provided informed consent, approved by the hospital review committee, prior to imaging studies. Dogs were randomized into 2 groups: an experimental group receiving cutaneous wound closure with the ZipLine 16 surgical skin closure device (Group 1) and a control group receiving staples or suture using a commercial applicator (Precise PGX-35W; 3M Health Care, Neuss, Germany) or 3-0 nylon (Ethilon; Ethicon, Somerville, New Jersey, USA) (Group 2). A total of 6 dogs were enrolled and 5 dogs completed the study (Table 1). The 6 dogs consisted of 4 dachshunds, 1 Chihuahua, and 1 mixed breed. Body mass ranged from 4.4 kg to 11.7 kg. There were 3 spayed females, 2 neutered males, and 1 intact female ranging in age from 3.8 to 8 y. The dog which failed to complete the study was presented with paraplegia and absent pain perception to the pelvic limb and tail for less than 24 h. The patient’s history, significant diffuse intramedullary hyperintensity identified on T2-weighted MRI images, and serial neurologic examinations were most consistent with progressive myelomalacia, and the owner elected humane euthanasia. Due to recurrence of clinical signs, 1 dog in the control group required revision surgery at the same site 5 d after being enrolled. For this patient the appositional skin healing was evaluated in the period following the second surgery. All of the dogs in this study received similar anesthetic protocols, surgical site preparation, and were prescribed similar postoperative medications and home care instructions at discharge. One of 3 control dogs received 3-0 nylon sutures in a Ford interlocking pattern for both dorsolateral hemilaminectomy procedures and the other 2 dogs received stainless steel staples. Time for suture placement was approximately 2 min, and time for staple placement was less than 1 min. A brief video tutorial providing instructions for application of the ZipLine 16 surgical skin closure device was reviewed by the surgeon (CS) prior to the surgical procedure, and all surgical wounds were photographed immediately after closure and again at discharge. In all cases, the device was applied in less than 2 min, and given this was longer than for staples, a reduction in time as the operator becomes more familiar, reduced infection, or improved healing would be necessary to justify its use in an emergency setting.

Table 1.

Dogs participating in the study in order of enrollment

ID number	Group	Breed	Age (y)	Gender	Weight (kg)	Hair color
1	1	Chihuahua	3.83	FS	4.4	Black
2	2	Dachshund	5	MN	10.7	Black/Tan
3	1	Dachshund	5	FS	4.1	Dapple
4	2	Mixed	4.75	MN	8.2	Brown/White
5	2	Dachshund	8	F	11.7	Black
6	1	Dachshund	7	FS	6.1	Black/Tan

FS — spayed female; MN — neutered male; F — female.

Control dogs had no skin changes or complications associated with the skin closure material. Removal of both sutures and staples was performed in 1 min or less, and no clinical signs of pain or discomfort were noted during removal of these materials. All dogs in the treatment group completed the study. The median time of removal was 14 d (range: 14 to 17 d). The same clinician (CS) performed removal of the ZipLine 16 device in each dog, and signs consistent with pain (vocalization, head turning, body movement) were observed in all treated dogs. Pain or discomfort was not anticipated to be significantly different between treated and control dogs, and therefore no objective pain scoring was performed. This adverse reaction of dogs to removal of the device, compared with that for staples or sutures, was not sufficiently outweighed by any obvious superiority of the trial device. Adhesive removing agents (Goo Gone; The Homax Group, Bellingham, Washington, USA; Eaze-Off; Millpledge Veterinary, Whinleys Estate, Clarborough, Retford, Nottinghamshire, UK) were also necessary to facilitate removal of the device, with an approximate removal time of 5 to 10 min. The adhesive removers were applied to cotton gauze which was then applied to the skin under the device as it was gently lifted so as to minimize dermal contact. The exact time of removal was not measured, as this was not part of the original study design. The study instead focused on complication rates and incisional healing, which in retrospect represents a significant limitation of the study. Multifocal areas of erythema and erosive dermitis with areas of hypertrichosis and mild scaling associated with contact between the adhesive portion of the device and the skin were noted in all treated dogs (Figure 2). While owners did not report long-term adverse effects, there were clear visual differences in tolerance to removal of the device compared to removal of surgical staples or suture.

Figure 2.

Photographs of surgical sites after the Zipline devices have been removed. a — Dog #1, device removed after 14 d. b — Dog #3, device removed after 14 d; c — Dog #6, device removed after 17 d.

The study was designed with an anticipated enrollment of 20 dogs to detect a clinically significant difference in adverse effects. However, the authors elected to terminate the study early after consultation with the neurology service due to the cutaneous complications associated with the device. The reasons for the increased dermal reactions in dogs compared with human patients were not identified in this study. Human guidelines allow for increased movement and water exposure, which may have the effect of gradually weakening the adhesive. The manufacturer (personal communication, Manager of Clinical Affairs, Zipline Medical, Campbell, California, June 9, 2015) recommends the use of specific commercial adhesive removers (Detachol; Ferndale Laboratories, Ferndale, Michigan, USA; Allkare; ConvaTec, Greensboro, North Carolina, USA), but only for those patients with known adhesive sensitivity or with disorders that affect the integrity of the skin. We employed different adhesive removers (Goo Gone; The Homax Group; Eaze-Off; Millpledge Veterinary) in this study because these products are commonly used for removal of adhesive incisional bandages (Tegaderm; 3M, Saint Paul, Minnesota, USA) at the study institution and were readily available. Anecdotally, skin reactions similar to those reported in the present investigation have not been observed following application for that purpose. The observed reactions could be due to unique species hypersensitivity, to differences in the composition of the epidermis, to haired skin, to the absence of perspiration in dogs, or the restriction of motion necessary during recovery after spinal surgery in veterinary patients. Additional investigation into the dermal sensitivity of dogs to other related adhesive human products is required.

This report documents the first attempted controlled trial of a non-invasive skin closure device similar to those increasingly used in human surgical practice. The dermal effects were mild but nonetheless substantial, compared with study and historical controls receiving sutures or staples. The short application time, the ease of administration, and lack of dermal penetration may favor the use of this product, but future investigations are necessary to examine other skin closure systems and to refine the appropriate adhesives for such devices to facilitate veterinary use. CVJ