tissue adhesives

1
CORRESPONDENCE Even more worrisome is that a "standard of care" has been determined for us by tele- vision shows, the occasional uncritically enthu- siastic and usually technophilic physician, para- medics, and fire chiefs, completely unsupported by other than anecdotal evidence. Real control and quality assessment by physicians, so much a principle in every other form of US medical care, is notably absent. So successful has been this setting of the standard by nonmedical means that we now cannot overcome the prob- lem of "unethical" trials of utterly unproven therapies. Perhaps the best place to direct our ener- gies right now would be to develop clear cri- teria for ethical investigations in EMS, similar to those developed for patients needing emer- gency resuscitation. These criteria would clarify that decades of traditional usage without evi- dence of benefit does not constitute a genuine standard of care that it would be unethical to investigate. Dr Cone's letter does remind me to once again thank all the concerned, hard-working paramedics and emergency physicians who do care about quality EMS and who have ex- pressed their support of my suggestions for substantial reform. They reinforce my belief that EMS as a whole is important enough to warrant high standards, traditional forms of proof, and quality research. Enough of the per- missive approach. Like an errant teenager (who scores low on the tests but has high self- esteem), what EMS needs now for both its own good and the good of the patients, is tough love. Michael Callaham, MD Division of Emergency Medicine UCSF Medical Center San Francisco, CA 1. Spaite OW, Criss EA, Valenzuela TO, et al: Emergency medical services systems research: Problems of the past, challenges of the future. Ann Emerg Med 1995;26:146-152. Tissue Adhesives To the Editor: I have the utmost respect for Dr Richard Edlich and the contributions he has made to the field of wound care, but I am offended by his edi- torial, "Tissue Adhesives-Revisited."1 As a researcher who spends most of his time on wound care, cosmetic outcomes, and tissue adhesives, I am disappointed that he feels 2 7 4 emergency medicine is "abandoning the care of traumatic lacerations." In contrast to his opinion, wound care research is flourishing in emergency medicine. In the past we depended on basic science models to guide us in the care of wounds. Recently we have started to test these findings with clinical trials to determine the true clinical importance of these models. 2 Our investigations, and work undertaken by Hollander and Singer, are truly the first attempt in any specialty to objectively study clinical outcomes in wound care and they should not be ignored or condemned 3 ,4 Dr Edlich says, " ... emergency physicians are forced to research other techniques such as adhesive glue," suggesting that we have resorted to some lower standard of care. Tissue adhesives are not a lower standard of care. When tissue adhesives are used properly, they can provide a fast, painless closure with cos- metic outcomes at least as good as traditional suturing. 5 Their properties are preferred by the majority of patients. 6 This is why they have been developed, not because we have "aban- doned wound care." No other new wound clo- sure device has undergone as much scrutiny as tissue adhesives. There have been 5 random- ized trials on lacerations and 2 on incisions all demonstrating their successful use compared with sutures. 5 .7-9 Tissue adhesives cannot re- place all sutures, and proper wound care must be followed when they are used for wound closure. Their use requires knowledge and tech- nical skills that should limit their use to knOWl- edgeable physicians. To suggest my colleagues would support over-the-counter use is an insult to them and anyone who knows anything about these compounds. . Dr Edlich should be aware that the octyl- cyanoacrylate formulation Dermabond is currently under review by the Food and Drug Administration and has passed all the ISO standards for toxicity and as such is the first cyanoacrylate to be classified as nontoxic.1O Its approval would be the first step to its wide- spread use as the first nontoxic medical-grade tissue adhesive (other cyanoacrylates were industrial adhesives adapted for medical use). However, we are far from satisfied with this formulation and are continuing to research changes in application techniques, different cyanoacrylate formulations, and a new gener- ation of nontoxic absorbable adhesives that could further revolutionize wound care. So take comfort, Dr Edlich. Emergency medi- cine is not abandoning the care of traumatic wounds. James Quinn, MD Section of Emergency Medicine University of Michigan Ann Arbor, MI 1. Edlich RF: Tissue adhesives-revisited. Ann Emerg Med 1998;31:106-107. 2. Hollander jE, Richman PB, Werblud M, et al: Irrigation in faCial and scalp lacerations: Does it alter outcome? Ann Emerg Med 1998;31:73-77. 3. Quinn jV, Drzewiecki AE, Stiell IG, et al: Appearance scales to measure cosmetic outcomes of healed lacerations. Am] Emerg Med 1995;13:229-231 . 4. Hollander jE, Singer Aj, Valentine S, et al: Wound reg- istry: Development and validation. Ann Emerg Med 1995; 25:675-685. 5. Quinn jV, Wells GA, Sutcliffe T, et al: A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. ]AMA 1997;227: 1527-1530. 6. Osmond MH, Klassen TP, Quinn jV: Economic compari- son of a tissue adhesive and suturing in the repair of pedi- atric facial lacerations.] Pediatr 1995;126:892-895. 7. Bruns TB, Simon HK, McLario OJ, et al: Laceration repair using a tissue adhesive in a children's emergency department. Pediatrics 1996;98:673-675. 8. Maw jL, QuinnJV, Wells GA, et al: A prospective com- parison of octylcyanoacrylate tissue adhesive and sutures for the closure of head and neck incisions. ] Otolaryngol 1997;26:26-30. 9. Kent TM, Bucknall TE: A clinical trial of tissue adhesive in skin closure of groin wounds. Med] Malaysia 1989;44: 122-128. 10. International Standards Organization, Association for Advancement of Medical Instrumentation: Biological Evaluation of Medical Devices, vol 4. Arlington, VA: International Standards Organization, 1995. In reply: Twenty-five years ago, our laboratory devel- oped the first microporous tape for wound closure. 1 The superiority of tape wound closure has been attributed to the resistance to infec- tion of the underlying wound that is greater than wounds containing sutures, staples, or tissue adhesives 2 This unique resistance to infection of tape-closed wounds has been attributed to the absence of the sutural, tissue adhesive, or staple foreign bodies in the wound. These wound closure tapes are ideally suited for closure of wounds subjected to low-static skin tensions. They have been used in an esti- mated 1 billion patients. The Food and Drug Administration (FDA) has approved their use for wound closure. Tape wound closure is well accepted by children because it can be achieved without discomfort. Despite the advantages ANNALS OF EMERGENCY MEDICINE 32:2 AUGUST 1998

Upload: james-quinn

Post on 02-Jul-2016

212 views

Category:

Documents


0 download

TRANSCRIPT

CORRESPONDENCE

Even more worrisome is that a "standard of care" has been determined for us by tele­vision shows, the occasional uncritically enthu­siastic and usually technophilic physician, para­medics, and fire chiefs, completely unsupported by other than anecdotal evidence. Real control and quality assessment by physicians, so much a principle in every other form of US medical care, is notably absent. So successful has been this setting of the standard by nonmedical means that we now cannot overcome the prob­lem of "unethical" trials of utterly unproven therapies.

Perhaps the best place to direct our ener­gies right now would be to develop clear cri­teria for ethical investigations in EMS, similar to those developed for patients needing emer­gency resuscitation. These criteria would clarify that decades of traditional usage without evi­dence of benefit does not constitute a genuine standard of care that it would be unethical to investigate.

Dr Cone's letter does remind me to once again thank all the concerned, hard-working paramedics and emergency physicians who do care about quality EMS and who have ex­pressed their support of my suggestions for substantial reform. They reinforce my belief that EMS as a whole is important enough to warrant high standards, traditional forms of proof, and quality research. Enough of the per­missive approach. Like an errant teenager (who scores low on the tests but has high self­esteem), what EMS needs now for both its own good and the good of the patients, is tough love.

Michael Callaham, MD Division of Emergency Medicine UCSF Medical Center San Francisco, CA

1. Spaite OW, Criss EA, Valenzuela TO, et al: Emergency medical services systems research: Problems of the past, challenges of the future. Ann Emerg Med 1995;26:146-152.

Tissue Adhesives

To the Editor:

I have the utmost respect for Dr Richard Edlich and the contributions he has made to the field of wound care, but I am offended by his edi­torial, "Tissue Adhesives-Revisited."1 As a researcher who spends most of his time on wound care, cosmetic outcomes, and tissue adhesives, I am disappointed that he feels

2 7 4

emergency medicine is "abandoning the care of traumatic lacerations." In contrast to his opinion, wound care research is flourishing in emergency medicine. In the past we depended on basic science models to guide us in the care of wounds. Recently we have started to test these findings with clinical trials to determine the true clinical importance of these models.2

Our investigations, and work undertaken by Hollander and Singer, are truly the first attempt in any specialty to objectively study clinical outcomes in wound care and they should not be ignored or condemned 3 ,4

Dr Edlich says, " ... emergency physicians • are forced to research other techniques such as adhesive glue," suggesting that we have resorted to some lower standard of care. Tissue adhesives are not a lower standard of care. When tissue adhesives are used properly, they can provide a fast, painless closure with cos­metic outcomes at least as good as traditional suturing.5 Their properties are preferred by the majority of patients.6 This is why they have been developed, not because we have "aban­doned wound care." No other new wound clo­sure device has undergone as much scrutiny as tissue adhesives. There have been 5 random­ized trials on lacerations and 2 on incisions all demonstrating their successful use compared with sutures.5.7-9 Tissue adhesives cannot re­place all sutures, and proper wound care must be followed when they are used for wound closure. Their use requires knowledge and tech­nical skills that should limit their use to knOWl­edgeable physicians. To suggest my colleagues would support over-the-counter use is an insult to them and anyone who knows anything about these compounds. .

Dr Edlich should be aware that the octyl­cyanoacrylate formulation Dermabond is currently under review by the Food and Drug Administration and has passed all the ISO standards for toxicity and as such is the first cyanoacrylate to be classified as nontoxic.1O Its approval would be the first step to its wide­spread use as the first nontoxic medical-grade tissue adhesive (other cyanoacrylates were industrial adhesives adapted for medical use). However, we are far from satisfied with this formulation and are continuing to research changes in application techniques, different cyanoacrylate formulations, and a new gener­ation of nontoxic absorbable adhesives that could further revolutionize wound care.

So take comfort, Dr Edlich. Emergency medi­cine is not abandoning the care of traumatic wounds.

James Quinn, MD Section of Emergency Medicine University of Michigan Ann Arbor, MI

1. Edlich RF: Tissue adhesives-revisited. Ann Emerg Med

1998;31:106-107.

2. Hollander jE, Richman PB, Werblud M, et al: Irrigation in faCial and scalp lacerations: Does it alter outcome? Ann

Emerg Med 1998;31:73-77.

3. Quinn jV, Drzewiecki AE, Stiell IG, et al: Appearance scales to measure cosmetic outcomes of healed lacerations. Am] Emerg Med 1995;13:229-231 .

4. Hollander jE, Singer Aj, Valentine S, et al: Wound reg­istry: Development and validation. Ann Emerg Med 1995;

25:675-685.

5. Quinn jV, Wells GA, Sutcliffe T, et al: A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. ]AMA 1997;227: 1527-1530.

6. Osmond MH, Klassen TP, Quinn jV: Economic compari­son of a tissue adhesive and suturing in the repair of pedi­atric facial lacerations.] Pediatr 1995;126:892-895.

7. Bruns TB, Simon HK, McLario OJ, et al: Laceration repair using a tissue adhesive in a children's emergency department. Pediatrics 1996;98:673-675.

8. Maw jL, QuinnJV, Wells GA, et al: A prospective com­parison of octylcyanoacrylate tissue adhesive and sutures for the closure of head and neck incisions. ] Otolaryngol

1997;26:26-30.

9. Kent TM, Bucknall TE: A clinical trial of tissue adhesive in skin closure of groin wounds. Med] Malaysia 1989;44:

122-128.

10. International Standards Organization, Association for Advancement of Medical Instrumentation: Biological

Evaluation of Medical Devices, vol 4. Arlington, VA: International Standards Organization, 1995.

In reply:

Twenty-five years ago, our laboratory devel­oped the first microporous tape for wound closure.1 The superiority of tape wound closure has been attributed to the resistance to infec­tion of the underlying wound that is greater than wounds containing sutures, staples, or tissue adhesives2 This unique resistance to infection of tape-closed wounds has been attributed to the absence of the sutural, tissue adhesive, or staple foreign bodies in the wound. These wound closure tapes are ideally suited for closure of wounds subjected to low-static skin tensions. They have been used in an esti­mated 1 billion patients. The Food and Drug Administration (FDA) has approved their use for wound closure. Tape wound closure is well accepted by children because it can be achieved without discomfort. Despite the advantages

ANNALS OF EMERGENCY MEDICINE 32:2 AUGUST 1998