The Case

A 3-year-old boy was seen in urgent care for a superficial laceration above the left eyebrow. The pediatrician had heard of the availability of topical skin adhesive that can be used in place of sutures to close wounds (trade name DERMABOND). This was the physician’s first experience using this agent, and there had been no training on its proper use in the department. The wound was close to the eye, the child squirmed during the application, and no eye protection was used during the procedure. After the procedure, the physician realized that the child could no longer open his eye, which had been partially sealed shut. An ophthalmologist evaluated the child the next day, and fortunately, there was no permanent injury.

The Commentary

It is unfortunate that this physician’s attempt at “ideal care” became so potentially disastrous. The complication was entirely preventable, as many medical errors are.(1) Thankfully, no long-term medical complications for the child resulted. However, it is difficult to quantify the negative impact this event has had on the patient’s (and in this case, the parents’) level of trust in this physician, and in physicians in general.

Tissue adhesives are an important alternative for Emergency Department and Primary Care physicians tasked with closing minor lacerations on frightened and non-compliant children. In a recent systematic review,(2,3) pooled data from many randomized controlled trials found that cosmetic outcome of adhesives is similar to that achieved with sutures. Tissue adhesives had a slightly higher rate of dehiscence. Other complications (infection, erythema, etc.) were not different, but patients had less pain and the procedural time was lower with the adhesives. Overall, these last two factors have tipped the scales in favor of the use of the tissue adhesives.

Interestingly, no study in the systematic review identified an adverse event of erroneous glue application, including accidental eye exposure, and no other surveillance study exists to report the incidence of these types of complications. Therefore, this case demonstrates the increasingly appreciated difference between efficacy and effectiveness: namely, outcomes achieved in well-controlled trials are often superior to those seen in “real-world” practice.(4,5) Bridging that gap requires careful attention to protocols and, for new products or devices, a thorough understanding of manufacturer recommendations and guidelines.

Proper use of tissue adhesives involves choosing appropriate wounds, as well as patients, for the procedure.(6) In order to avoid patient movement, the patient must understand, in advance, what the physician is about to do. In the case of a child, selecting a calm co-operative patient, or one that can be appropriately and safely restrained for the brief procedure, is paramount. Prior to applying the product, hemostasis must be achieved with either pressure or topical application of a vasoconstrictor solution. This ensures that the wound edges can be visualized and that the tissue adhesive does not polymerize too quickly, resulting in pain for the patient and a poorly adherent bond. The patient should be positioned to ensure that run-off of tissue adhesive is minimized (horizontal plane), and that if it does occur, it will move away from unwanted areas, such as the eye. Protective gauze should be maintained over high-risk areas as secondary protection from run-off as well as from accidental drops. While the manufacturer recommends petroleum jelly as a mechanical barrier or dam,(7) care must be taken to not get the petroleum jelly near the laceration, as it will soften the tissue adhesive prematurely, possibly resulting in wound dehiscence.

Following these simple and intuitive steps will prevent most adverse events, but complications may still occur. In the event of accidental instillation of tissue adhesive into the eye, it is critical not to panic. Consider that ophthalmologists routinely use tissue adhesives for corneal repairs and globe perforations.(8) The product will not damage the cornea. Apply ophthalmic ointment to the eye and affected lashes, patch the eye closed, and arrange for follow-up in 24 hours. The ointment will act to soften the tissue adhesive, allowing it to be easily picked from the lashes without the need to cut them. For erroneously placed tissue adhesive on intact skin (ie, fingers glued together), acetone can be used.(6)

While it is easy to blame the physician in this case for not recognizing his inexperience and lack of training before choosing tissue adhesive, a larger systems issue is at fault. Why was the product available for general use before any training or orientation had been provided to the users?

Though it is hard to view the use of tissue adhesives as “invasive,” they are part of the list of procedures from which complications are the leading cause of iatrogenic injury.(9) As such, the Institute of Medicine’s landmark report, “To Err is Human: Building a Safer Health System,”(10) recommended that permanent committees dedicated to safety improvement were needed. Specifically, these committees should work toward “standards related to the introduction and diffusion of new technologies, therapies and drugs.” The Emergency Department, by the nature of its complex business, multitude of procedures involved in provision of care, and large numbers of staff, is a high-risk area for adverse events.(10,11) It, therefore, requires a standardized approach to introducing new technologies with a view of minimizing adverse events.

The framework for identifying and introducing new products should be included in a written policy adopted by either the department, or the institution as a whole. The department director, nurse manager, or nurse educator are typically responsible for ensuring the policy is followed. Before any new technology, product, or medication is released for use, all staff needs to be formally notified. Simple additions, such as changing the formulation of children’s ibuprofen elixir that will be stocked, requires only an e-mail to all staff and posters in the medication room reminding staff of the change. With more complex products, such as new defibrillators, documented completion of hands-on training and/or supervised patient encounters may be necessary to ensure the user has gained the procedural skill component needed to safely use the product. In these situations, all affected staff may be required to complete the certification before the product can be released for general use. These training sessions need to introduce the product, the indications and contraindications, potential complications and how to deal with them, and finally, how to minimize adverse events. The department director and/or nurse manager should be responsible for determining the extent of notification or training required, and for identifying which staff will be affected by the new product.

In developing the training that staff will need, the product manufacturer is typically a good place to start. They may have already developed training material or even patient simulation modules for staff to practice on. A good example of this involvement is the training materials (mannequins, videos, handouts, CD-ROMs, etc.) produced by Cook® for introducing their central line and advanced airway equipment to staff. Another example is a demonstration on DERMABOND itself, available on the Ethicon™ Web site. In the end, manufacturers have a stake in ensuring that their product is used safely and for the correct indications.

Finally, the policy should ensure that a system is in place to monitor these new technologies for adverse events that may occur, with the requirement for mandatory, yet non-punitive, disclosure. After all, the only way to improve on a problem is to first know that it exists.

Ken J. Farion, MD Emergency Medicine Assistant Professor, Departments of Pediatrics and Medicine University of Ottawa Ottawa, Ontario, Canada

References

1. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324:370-6.[ go to PubMed ]

2. Farion K, Osmond MH, Hartling L, et al. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2002;CD003326.[ go to PubMed ]

3. Farion KJ, Osmond MH, Hartling L, et al. Tissue adhesives for traumatic lacerations: a systematic review of randomized controlled trials. Acad Emerg Med. 2003;10:110-8.[ go to PubMed ]

4. Brook RH, Lohr KN. Efficacy, effectiveness, variations, and quality. Boundary-crossing research. Med Care. 1985;23:710-22.[ go to PubMed ]

5. Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology: The Essentials. 3rd ed Baltimore: Williams & Wilkins; 1996.

6. Quinn JV. Tissue adhesives in wound care. Hamilton: B.C. Decker Inc.; 2003.

7. DERMABOND® Topical Skin Adhesive [package label]. Sommerville, New Jersey: Ethicon, Inc.; 2003. [ go to related site ]

8. Leahey AB, Gottsch JD, Stark WJ. Clinical experience with N-butyl cyanoacrylate (Nexacryl) tissue adhesive. Ophthalmology. 1993;100:173-80.[ go to PubMed ]

9. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:377-84.[ go to PubMed ]

10. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Washington, D.C.: National Academy Press; 2003.

11. Cosby KS, Croskerry P. Patient safety: a curriculum for teaching patient safety in emergency medicine. Acad Emerg Med. 2003;10:69-78.[ go to PubMed ]