Cases & Commentaries

A Little Shuteye

Commentary By Ken J. Farion, MD

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
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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 ]