clinical experience with 2-OCA in an emergency department
BY ANN SHIMKUS, PA-C
Tissue adhesives, cyanoacrylates, have been used in various parts of the world for closure of cutaneous lacerations for more than 20 years. These adhesives have been used in a variety of medical settings, including otolaryngology for middle ear surgery, ophthalmology to repair perforated corneas, gastroenterology for the occlusion of varices and midwifery to close the perineum.1-4
In an emergency department setting, tissue adhesives can close wounds and serve as an alternative to other forms of wound closure. The benefits can include cost reduction, decreased pain and anxiety and time savings.
Numerous studies have evaluated the use of butylcyanoacrylates, but since its recent approval by the U.S. Food and Drug Administration, few studies have evaluated the effectiveness of octylcyanoacrylates such as 2-octyl cyanoacrylate (2-OCA), known commercially as Dermabond.
Butyl derivatives, which have been used more extensively, have their limitations. Studies have shown that day-one breaking strength is only about 10% to 15% that of a wound closed with 5-0 monofilament sutures, although it is equal to suture repair at five to seven days.5
The butyl derivatives are less flexible, subjecting them to becoming brittle and fracturing when used over a skin crease, areas of movement or long lacerations.5 Octylcyanoacrylate is a longer-chain formulated cyanoacrylate that has more flexibility and a three-dimensional breaking strength four times that of n-2-butylcyanoacrylates.5 Butylcyanoacrylates have not gained FDA approval, whereas the octyl derivatives have.6 Dermabond is the first cyanoacrylate adhesive to be approved for topical wound closure in the United States.7 This article evaluates the use and effectiveness of Dermabond in an adult and pediatric ED setting by physicians and PAs.
More than 12 million traumatic wounds are evaluated in EDs annually in the United States, and most require some form of wound closure.8 The cyanoacrylates are a group of synthetic adhesives that polymerize in an exothermic reaction on contact with fluid or a basic substance to form a strong bond for wound closure.5
In 1949, cyanoacrylates were first synthesized but were not used in clinical settings until the late 1950s.9 The early derivatives of cyanoacrylates had short alkyl chains, which caused them to degrade rapidly into cyanoacetate and formaldehyde.9 These products would accumulate in tissues and lead to significant tissue toxicity. The short-chain derivatives therefore have been limited to products such as "Krazy Glue."10
Longer-chain butyl derivatives were developed in the 1970s and 1980s and were found to have little toxicity when used topically.10 Cyanoacrylate tissue adhesives have been approved for use in Canada since 1975 and are used extensively throughout Israel, Europe and the Far East.9 The FDA approved 2-OCA for U.S. marketing in August 1998.
Tissue adhesives may not replace traditional forms of wound closure, but they can serve as an alternative for repair. The advantages of tissue adhesives can be appreciated in the decreased need for anesthetics, which can cause anxiety and discomfort. The risk of needle stick injury is reduced because fewer syringes and needles are required. Costs decrease as well, because adhesives can reduce the need for suture trays, dressings and return visits for suture removal. Reduction in repair time can also translate into improved patient turnaround times.5,11
There are limitations to the use and effectiveness of tissue adhesives. Contraindications include areas of active infection, mucosal surfaces and across mucocutaneous junctions.12 Ethicon Inc., Dermabond's maker, recommends avoiding areas regularly exposed to body fluids or areas of dense hair, such as the scalp. When used across high skin tension, such as knuckles, elbows or knees, Dermabond should be accompanied with splinting to immobilize the joint.6,12
Deep sutures should be placed when closing facial lacerations under tension and deep lacerations on the torso and extremities.6,10,13 When using tissue adhesives, careful wound exploration, irrigation and debridement are still required, and local anesthesia may be necessary for these procedures.10 The adhesive usually sloughs off on its own within seven to 10 days, and generally no follow-up is required.
Based on previous studies, the expectation exists that tissue adhesives have comparable cosmesis scores and infection rates.
Review of Literature
Histoacryl Blue (n-butyl-2-cyanoacrylate) has been used in ED settings and studied extensively. Dermabond is still relatively new, given its recent FDA approval, and its studies are few.
Bruns, Robinson and colleagues evaluated 2-OCA at a children's hospital in 1996.6 Eighty-three children were randomized to receive either 2-OCA or sutures or staples. The length of time for cutaneous closure was decreased with a median of 2.9 minutes for the 2-OCA group and a median of 5.8 minutes for sutures or staples.
The parents' assessment of the pain felt by their child in the 2-OCA group was less but not significantly different than that of the conventional group. Ninety-five percent of parents whose child received the tissue adhesive for wound closure would choose 2-OCA over sutures or staples at their next visit for laceration repair.
Evaluation by plastic surgeons showed that the cosmesis scores of tissue adhesives were slightly lower than sutures, but not statistically significant. Complications included one wound infection in the 2-OCA group, and no wound dehiscence occurred in either group.
Singer and colleagues evaluated its use with a prospective, randomized, controlled trial in an adult and pediatric ED setting.13 Sixty-three patients were randomized to the 2-OCA group, and 61 patients were treated with standard wound closure. Wounds secondary to bites, punctures, decubitus ulcers or crush injuries that had resulted in stellate lacerations were excluded.
At the five- to 10-day follow-up, only one wound was infected in the 2-OCA group, and two wounds from this group required reclosure due to dehiscence. At long-term follow-up, the cosmetic appearances were similar for the two groups. The mean cosmetic score for patients whose wounds were closed with 2-OCA was 83.8 ± 19.4 mm. The mean cosmetic score for the standard technique was 82.5 ± 17.6 mm; p=0.67. Physician assessments of cosmetic appearance were also similar between the two groups.
The 2-OCA group received an optimal cosmetic score of 77%, whereas the other group received 80%, with p=0.67. They conclude a low rate of dehiscence, a low infection rate and excellent cosmetic results with use of 2-OCA; however, they advocate using deep sutures on wounds subjected to large static and dynamic tension to reduce tension.
A Canadian study by Quinn and colleagues concluded that repetitive movement and washing the adhesive would result in the top layer of the epidermis to peel off in only a few days before complete healing has occurred.5 They do not recommend tissue adhesives to be used on hands and over joints. The researchers found that their suture group had statistically insignificant higher cosmesis and wound evaluation scores when they evaluated tissue adhesives vs. suturing.
Toriumi and colleagues studied 2-OCA in a facial plastic surgery setting on patients undergoing elective surgical procedures.14 Patients were randomized into either a control group with suture closure or into a test group with tissue adhesive closure. There were no instances of wound dehiscence or infection in either group. Visual analog scale ratings showed scores of 21.7 ± 16.3 for the 49 patients treated with 2-OCA and 29.2 ± 17.7 for the 51 control patients; p=0.03. They report a statistically significant difference between the two groups and superior cosmetic outcome with use of 2-OCA. The authors conclude that overall excellent cosmetic results and absence of complications can be attributed in part to the fact that most of the incisions were clean incised wounds with appropriate use of subcutaneous sutures. They also acknowledge that less-optimal results may be expected in traumatic wounds that are closed without the use of subcutaneous sutures.
A German study conducted by Saxena and colleagues evaluated the use of 2-OCA in the repair of pediatric extremity lacerations.15 Thirty-two children with lacerations on the hands, feet and over joints had Steri Strips and splints both applied over the wound closures. The mean length of the laceration was 2.4 ± 1.2 cm, with two wound dehiscences that closed uneventfully. They report that 2-OCA adhesive applied with optimal immobilization was an effective measure of skin closure in high-skin tension lacerations.
Our study took place at Exempla Lutheran Medical Center in Wheat Ridge, Colo., between September 1998 and April 1999. The setting included both the convenience-care (fast-track) and emergency department adult and pediatric patients. Dermabond brand of 2-OCA was used by PAs and family practice and emergency medicine physicians following an hour-long in-service and video instruction provided by an Ethicon Inc. representative. Some physicians had already been instructed in the use of tissue adhesives in their previous training.
Patients or parents were informed and given the option of receiving either Dermabond or sutures if their wound had the potential to be repaired with the tissue adhesive. Providers were left to their own judgement to decide whether the location and type of wound could be repaired with a tissue adhesive. Patients or family members who chose Dermabond were sent home with aftercare instructions, including infection recognition; avoiding scratching, rubbing or picking; keeping the wound dry; and not applying liquid or ointment medications to the wounds.
Cosmetic appearance and the avoidance of infection are generally the key factors as to whether or not a type of wound closure is successful. The key factors assessed with our evaluation included infection and dehiscence rates, patient or parent satisfaction with cosmetic appearance and pain of procedure. Appearance and sensation of pain are for the most part subjective interpretations. Attempts to objectify the appearance and pain were done using a numeric rating scale. Numeric rating scales have demonstrated good validity as measures of pain intensity with strong correlations to other intensity measures.16
Follow-ups were conducted via telephone and mail 10 days and 90 days following the wound closure, thereby relying on patients' or parents' perceptions of appropriate appearance, dehiscence and infection rates. Every attempt was made to standardize parameters for infection and dehiscence with specific questions addressing signs and symptoms of infection and length and day of dehiscence. If relevant, patients or parents were asked to compare pain and scar appearance in similar areas of the body that had been previously sutured.
A standardized questionnaire was used to assess the patients' or parents' experiences and outcomes. The first question addressed at the 10-day follow-up was whether or not the wound became infected. If the response was yes, qualifiers such as signs and symptoms were used. It was then determined if the infection required oral antibiotics, topical care or glue removal, or whether a repeat visit was necessary.
The second question addressed whether or not the wound separated prematurely. Qualifiers included the day it separated, size of separation and what repair, if any, was required following the separation. Patients or parents were then asked if they or their children had received sutures in the past and to rate that pain using a numeric rating scale from 0 to 10, with 0 correlating to no pain at all and 10 being the worst pain imaginable. This same scale was used to assess the pain experienced with the Dermabond application. It was then asked if they found that the wound was easy to care for. The last question addressed whether or not the patient or parent would choose tissue adhesive repair in the future.
The 90-day follow-up questionnaire assessed the satisfaction of scar appearance using a modified numeric rating scale from 0 to 5, with 0 correlating to being the least satisfied and 5 being most satisfied. It was then asked if there had been previous sutures on a similar area where the glue was used. If yes, then a rating of the scar appearance was assessed using the same 0 to 5 scale. Patients or parents were then asked again if they would choose the glue in the future.
A questionnaire was also distributed to the physicians and PAs to evaluate their impressions on the use, feasibility and experience with Dermabond.
One hundred patients with 105 lacerations were evaluated within a seven-month time period between September 1998 and April 1999. Ages of 58 male patients and 42 female patients ranged between 1 and 86 years with most patients being younger than 6 years old.
Seventy-three lacerations occurred on the face, two on the scalp, 26 on the extremities, three on the abdomen and one on the flank, all of which were closed with Dermabond. The average length measured 1.5 cm, and only one required subcuticular sutures. Wound preparation was done primarily using Shurclens and normal saline with four patients requiring local infiltration of lidocaine. Lidocaine with epinephrine was used topically in four other patients to assist in hemostasis.
Out of the 73 facial lacerations, there were nine instances (12.3%) of 3 to 6 mm of wound separation or premature removal of Dermabond. One 6-year-old removed the tissue adhesive from her face in two days. One 7-year-old with a cheek laceration was returned within two hours for Dermabond removal and suture repair as the wound was pulling apart laterally with smiling.
There were a total of three facial infections (4.1%). Two of the wounds that were infected also opened prematurely, one of which required oral antibiotics. One wound that was reported to be red was treated with hydrogen peroxide but did not separate. Seven lacerations on the eyelids were closed, and one resulted in an inadvertent closure of the eye, which required ophthalmic ointment, patching and ophthalmology consult. The eye opened uneventfully two days later.
Of the 26 extremity lacerations, there were 11 instances (42.3%) of 7 to 13 mm of wound separation or premature removal of the adhesive. Seven of these occurred on the digits despite two of them being splinted. Two occurred on the arm and forearm, neither of which was splinted. One 7-year-old partially removed the adhesive from his toe. One adult partially removed the adhesive from his forearm when he was cleaning it. Only one of the 11 dehiscences was subsequently repaired with sutures. One returned the next day for reapplication of Dermabond, because the top layer had come off. There was only one extremity infection. This occurred on the forearm, with subsequent dehiscence and the requirement of oral antibiotics.
The remaining six lacerations on the scalp, trunk and abdomen all healed uneventfully.
There were 45 closures performed by physicians with nine separations (20%) and two infections (4.4%). Sixty closures were done by PAs with 11 separations (18.3%), two infections (3.3%) and one inadvertent application to the eyelid resulting in closure of the eye.
Concerning pain, two parents were unable to assess their child's pain with the application of the tissue adhesive, and one was lost to follow-up. Forty-five stated there was no pain with its application, and one parent ranked her child's pain a 10. Using the verbal numeric scale, the average pain with Dermabond was 1.48.
Only 36 people had had previous sutures, with one reporting no pain with sutures. The average pain with sutures was 5.49 (Figures 1 and 2). Five people did not feel that the wound was easy to care for, and in each of these cases, there was separation of the wound.
At the 10-day evaluation point, 77 parents or patients would use a tissue adhesive in the future, four stated they would not, 18 were undecided and one was lost to follow-up. At the 90-day follow-up point, 75 (84.3%) would choose future use, 12 (13.5%) would not, two were undecided and 11 were lost to follow-up. Of the 18 who were undecided at the 10-day evaluation, 11 chose to use Dermabond in the future, five decided against future use and two were lost to follow-up. Of the initial 77 who chose future use at the 10-day point, three changed their minds and six were lost to follow-up.
A satisfaction scale for scar appearance was assessed at the 90-day mark (Figure 3). There were 46 (51.7%) who were the most satisfied with scar appearance and ranked it a 5. Five stated they were the least satisfied with appearance and ranked it a 0. Two patients had premature removal of the adhesive and could not be adequately assessed and nine were lost to follow-up. Eleven people had previous sutures in a similar area where the adhesive was used. Four stated the scar appearance from Dermabond was better, four stated the appearance from sutures was better, and three ranked the appearance the same for both methods.
Tissue adhesives such as Dermabond are currently being used in ED settings as an alternative to suturing. Just as suturing requires a certain level of proficiency, so too does the use of a tissue adhesive for wound closure. Careful approximation and hemostasis is vital in achieving successful closure. Fingers or forceps are generally used to appose wound edges, with pressure or topical epinephrine serving to control hemostasis.
Dermabond comes in an ampule, which is crushed and squeezed onto a foam tip applicator. Currently, the adhesive is of low viscosity and has a tendency to run; therefore, it is important to ensure that the laceration is in a horizontal plane for application. The adhesive is lightly painted over the apposed wound edges in three repetitive strokes, allowing for 30-second drying times between each layer, with full strength reached in two and a half minutes.12
If the adhesive is inadvertently applied to an undesirable area, it can usually be wiped off before it sets or removed with acetone. If the adhesive inadvertently gets onto the eyelid and results in closure, which has happened given its low viscosity and tendency to run, ophthalmic ointment and patching of the eye is necessary. The adhesive will then slough off uneventfully within 24 to 48 hours.10
If the applicator is pushed into the wound, the edges can separate and cause the adhesive to be deposited in the wound. If this occurs, the adhesive acts as a barrier to epithelization and causes a wide scar. It also has the potential to cause a foreign-body reaction and increased infection when placed in the wound.10
Additional ointments or dressings are not required, because the adhesive forms its own sterile dressing. Ointments and soaking and washing the area are discouraged, because the skin can become macerated, and the adhesive may slough off prematurely, according to Ethicon Inc. Protective dressings may be applied after the adhesive has completely dried, which is approximately five minutes.
Our experience with Dermabond showed that we had poor results when it was used on the extremities, despite the use of splints and regardless of whether it was used on an adult or child. Review of the literature reveals variable outcomes and opinions. Quinn and colleagues do not recommend using 2-OCA on hands, over joints or in areas with repetitive movement.5 Bruns and colleagues recommend its use if the joint is immobilized.6 Saxena and colleagues used a combination of Steri Strips and splinting on 32 extremity lacerations in children, with only two reported wound dehiscences.15 Despite the recommendation for immobilization, areas on the extremities may be too moist from washing and perspiration for Dermabond to be effective.
Use of Dermabond on other parts of the body had greater success rates. Facial wounds, unless superficial, might benefit from subcuticular closure in addition to a tissue adhesive, given their mobility potential. Only one of our practitioners used subcuticular sutures in addition to the adhesive on the face. Toriumi and colleagues recommend appropriate subcuticular use in facial lacerations to eliminate subcutaneous dead space, maximize skin edge eversion and decrease wound tension.14
Some parents did not advocate use on the chin because it was difficult to keep that area dry on their child. One possible explanation for the rate of wound separations might be due to poor wound approximation, with some of the adhesive actually being deposited into the wound and preventing adequate healing.
Two successful closures were done on the scalp, despite previous recommendation not to use it on areas of dense hair.12 Histoacryl Blue has been used effectively on scalp lacerations, and this may be a successful area for future use of Dermabond.6
Four of the 105 wounds (3.8%) were reported to be infected following the use of Dermabond. In general, wound infection rates vary from 1% to 31% depending on the wound location, size, cause, presence of foreign bodies and time until treatment has begun.17 In two previous studies, wounds sutured in the ED had infection rates of 6% to 7%.17,18 Butyl and octyl cyanoacrylates alike have been found to possess antimicrobial effects against Gram-positive organisms, the mechanism for which is poorly understood.19 To demonstrate that tissue adhesives have a significant lowering of wound infection rates, thousands of patients would need to be studied to demonstrate a 20% reduction in infection rates from one treatment over another.17
The majority of patients or parents reported little to no pain with the application of Dermabond. Some reported a slight burning sensation, which can be attributed to the heat generated from the exothermic reaction of the adhesive polymerizing with the skin. The amount of heat released is related to the amount of blood or tissue fluid present and the amount of adhesive applied.19 This can be an important consideration in the clinical setting to minimize pain by ensuring a dry wound and appropriate application of adhesive.
Of the respondents at the 90-day follow up, 75 (84.3%) were pleased with the performance of Dermabond and would choose it again in the future. Parents were particularly pleased that their children did not have to be subjected to a needle and return for suture removal.
Some children found delight in telling their friends that they had been glued back together again. Satisfaction with scar appearance was high. Suprisingly, nine of 20 patients who reported wound separations were very satisfied with scar appearance and ranked them as being either a 4 or a 5 at the 90-day point. This raises a question as to how much dehiscence actually occurred.
Twenty practitioners were surveyed after the study. Ninety percent were impressed by how quick and easy it was to use with improved patient turnaround times averaging 20 minutes. Some, however, felt that the applicator was poorly designed and the low viscosity caused the adhesive to run too easily. Suggestions for other practitioners concerning the use Dermabond included practicing controlling the applicator, using caution around the eyes and not using excessive amounts. Some recommended the use of a forceps for approximation, while others preferred manual approximation. Nineteen of 20 (95%) would continue to use Dermabond when appropriate and available.
The use of tissue adhesives for wound closure certainly has a role in the ED setting. Decreased costs can be appreciated with a reduction in supplies, no return visit for suture removal, and improved patient turnaround times.
Overall satisfaction by parents, patients and practitioners is high. Patients need to be provided with appropriate wound care instruction, since the traditional methods do not apply to a wound repaired with a tissue adhesive. Cleaning the wound and the use of antibiotic ointment can result in premature removal of the tissue adhesive. Keeping the area dry is essential; if this is not possible, a tissue adhesive may not be appropriate.
There is no significant difference between wounds closed by physicians and PAs. Careful approximation of the wound edges and control of the applicator are vital for successful results. The recognition of when and where to use Dermabond is equally as important. Some lacerations closed with a tissue adhesive can benefit from the use of subcuticular sutures to eliminate dead space, maximize eversion and decrease skin tension.
Future studies should assess Dermabond use on other areas such as the scalp and extremities. The possibility exists for tissue adhesives to be effective on extremity lacerations if a combination of both Steri Strips and splints are used. The potential for reduced infection rates in wounds closed with tissue adhesives needs to be compared with suturing on a greater scale. *
1. Leahey AB, Gottsch JD, Stark WJ. Clinical experience with N-butyl cyanoacrylate (Nexacryl) tissue adhesive. Ophthalmology. 1993;100:173-180.
2. Toriumi DM, O'Grady K. Surgical tissue adhesives in otolaryngology-head and neck surgery. Otolaryngol Clin North Am. 1994;27:203-209.
3. Binmoeller KF, Soehendra N. Nonsurgical treatment of variceal bleeding: new modalities. Am J Gastroenterol. 1995;90:1923-1931.
4. Adoni A, Anteby E. The use of Histoacryl for episiotomy repair. Br J Obstet Gynaecol. 1991;98:476-478.
5. Quinn J, Wells G, Sutcliffe T, et al. A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. JAMA. 1997;277:1527-1530.
6. Bruns TB, Robinson BS, Smith RJ, et al. A new tissue adhesive for laceration repair in children. J Pediatr. 1998;132:1067-1070.
7. DERMABOND topical skin adhesive. Int J Trauma Nurs. 1999;5(1):29-31.
8. Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997;337:1142-1148.
9. Trott AT. Cyanoacrylate tissue adhesives. An advance in wound care. JAMA. 1997;277:1559-1560.
10. Maw J, Quinn J. Cyanoacrylate tissue adhesives. Am J Cosmetic Surg. 1997;14:413-416.
11. Bruns TB, Simon HK, McLario DJ, Sullivan KM, Wood RJ, Anand KJS. Laceration repair using a tissue adhesive in a children's emergency department. Pediatrics. 1996;98(4 pt 1):673-675.
12. Dermabond Topical Skin Adhesive [package insert]. Somerville, NJ: Ethicon Inc; 1998.
13. Singer AJ, Hollander JE, Valentine SM, Turque TW, McCuskey CF, Quinn JV. Prospective, randomized, controlled trial of tissue adhesive (2-octylcyanoacrylate) vs standard wound closure techniques for laceration repair. Stony Brook Octylcyanoacrylate Study Group. Acad Emerg Med. 1998; 5:94-99.
14. Saxena AK, Willital GH. Octylcyanoacrylate tissue adhesive in the repair of pediatric extremity lacerations. Am Surg. 1999;65:470-472.
15. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27:117-126.
16. Toriumi DM, O'Grady K, Desai D, Bagal A. Use of octyl-2-cyanoacrylate for skin closure in facial plastic surgery. Plast Reconstr Surg. 1998;102:2209-2219.
17. Hollander JE, Singer AJ, Valentine S, Henry MC. Wound registry: development and validation. Ann Emerg Med. 1995;25:675-685.
18. Rutherford WH, Spence RAJ. Infection in wounds sutured in the accident and emergency department. Ann Emerg Med. 1980;9:350-352.
19. Osmond MH. Pediatric wound management: the role of tissue adhesives. Pediatr Emerg Care 1999;15:137-140.