Patient Satisfaction With a Tissue Adhesive in Preauricular Fistulectomy

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Address correspondence to:
Dong-Hee Lee, MD
Department of Otolaryngology-Head and Neck Surgery
Uijeongbu, St. Mary’s Hospital, The Catholic University of Korea
#65-1 Gumoh-dong, Uijeongbu City, Gyeonggi-do
480-717, Korea
Phone: 82-31-820-3564
E-mail: leedh0814@catholic.ac.kr [5]

Abstract: Objective. To evaluate the usefulness of Dermabond® (octyl-2-cyanoacrylate) tissue adhesive, and to provide advice on its use for patients undergoing preauricular fistulectomy. Study design. A retrospective, IRB-approved, case-control study. Methods. This study reviewed the medical records of patients who underwent preauricular fistulectomy by one otologist at a single institution. Patient satisfaction was assessed by a questionnaire and the cosmetic result was assessed using the Hollander Wound Evaluation Scale (HWES). Results. There were 2 cases of wound dehiscence; a stitch abscess was noted in 2 patients. Aesthetically, scar appearance was considered very good. Among 33 patients who expressed an opinion postoperatively regarding the use of the tissue adhesive for skin closure, the degree of satisfaction was considerably high because patients were able to wash their face and bathe/shower (28 patients) soon after the procedure, followed by the lack of any dressing or wound care (21 patients), and the lack of skin sutures (19 patients). Conclusion. The tissue adhesive offered equivalent wound closure as traditional suture for preauricular fistulectomy. Tissue adhesive is a safe method for closing wounds in preauricular fistulectomy and has many advantages, especially in young children and young women.

     There is an increasing demand for office-based outpatient procedures performed by otolaryngologists. For patients who undergo office-based outpatient procedures or are discharged from the hospital prior to stitch removal, the dressing and care of the surgical wound are not only important, but often troublesome to both patients and surgeons.

   The goals of skin closure are to provide a favorable cosmetic and functional surgical result. It is also important to protect the surgical wound from infection. Meticulous approximation of subcutaneous tissues is an important prerequisite for a favorable outcome. Properly placed subcutaneous sutures aim to maximize skin-edge eversion and relieve tension on the wound.¹ The authors have previously used 5-0 nylon suture material for epidermal closure in the face, and usually left it in place for 5 to 7 days.

   Preauricular sinuses or fistulae are common congenital malformations. Once infection occurs, the likelihood of recurrent acute exacerbations is high, and preauricular fistulectomy is inevitable.² Since a time gap exists between operation (for an outpatient) or discharge (for an inpatient) and suture removal, frequent re-dressing of the surgical wound is required over the subsequent 4–5 days. Dressing care can be bothersome, especially for patients who live far from the hospital and do not have an otolaryngology clinic nearby. Additionally, suture removal can produce anxiety, particularly in children or women.³ Due to these concerns, the authors began using Dermabond® tissue adhesive (octyl-2-cyanoacrylate; Ethicon Inc, Somerville, NJ) for more than 1 year.

   The goal of this study was to examine the efficacy and advantages of the tissue adhesive in skin closure of a preauricular fistulectomy from the viewpoint of the patient.

Patients and Methods

   Patient selection. This retrospective, institutional review board-approved study reviewed the medical records of patients who underwent a preauricular fistulectomy (complete extirpation of the sinuses) at the otolaryngology head and neck surgery department of a University-based and secondary referral hospital over a 3-year period. This study included only those patients who had a classical preauricular fistulectomy (no incision and drainage) and those patients who could receive follow-up for at least 3 months.

   The advantages and disadvantages of the tissue adhesive, including the additional cost, were explained to the patients preoperatively. The adhesive was used only for those patients who gave written permission. Those who permitted its usage were called the adhesive-sutured group, and the others were referred to as the 5-0 nylon-sutured group.

   Surgical preauricular fistulectomy techniques. Adult patients underwent the operation under local infiltrative anesthesia as outpatients; children were given general endotracheal anesthesia and were admitted for 2–3 days. Preauricular fistulectomy was performed as follows: to prevent incomplete removal, the sinus tracts were dissected meticulously; a probe was used in all cases to define the sinus tracts. The portion of auricular cartilage attached to the sinus tract was usually removed. All cystic structures and fibrous tissues within the superficial temporal vessels, temporalis fascia, and conchal cartilage, were removed completely. A silastic drain was usually inserted to minimize any dead space during wound closure. For all patients, a subcutaneous re-approximation was made with an interrupted 4-0 Vicryl suture (Ethicon Inc, Somerville, NJ).

   Surgical skin closure techniques. For the patients whose skin was closed with a 5-0 nylon suture, the epidermal approximation was made in an interrupted simple or vertical matrix. The silastic drain, which was usually about 3 mm x 20 mm, was inserted through the surgically incised wound. In the time between operation (for outpatients) or discharge (for inpatients) and suture removal, it was recommended that the patients change the dressing on a daily basis in addition to keeping the wound dry.

   For the patients whose skin was approximated with the tissue adhesive, a small opening was made for a silastic drain before the subcutaneous suture. A #11 bladed knife made this opening from the most-dependent portion of the surgical wound to the orifice of external auditory canal away from the auricular cartilage; this portion was very thin and facilitated insertion of a silastic drain. After the silastic drain was inserted and a subcutaneous suture was made with a 4-0 Vicryl suture, the skin was cleaned with saline- and alcohol-soaked gauze where the tissue adhesive was applied. It was [2]applied over the skin incision in multiple thin layers (Figure 1). A 10- to 20-second delay between applications was required to allow the previous layer to dry. A 1- to 2-mm gap between the applicator tip and the skin surface was maintained to create surface tension during application. After it dried, a compression dressing was applied. The silastic drain was left in the wound for 1–2 days, and thereafter was removed along with the compression dressing. Inpatients were discharged without a wound dressing on the day when the compression dressing and a silastic drain were removed. The only coverage consisted of a cotton ball placed on the cavum concha, which was enough to cover the drain-inserted site. Immediately after discharge, the patients were allowed to wash their face and hair, or to shower/bathe.

   Evaluations. Postoperative photographs of all patients were taken at least 1 month after the operation. One otologist assessed unidentified photographs and was blinded to the type of wound closure received (the tissue adhesive versus 5-0 nylon suture). The cosmetic outcome was rated using the Hollander Wound Evaluation Scale (HWES).⁴ The HWES evaluates 6 cosmetic appearances, including stepoff of borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall cosmetic appearance of the wound. A score of 0 on this binary scale represents a poor esthetic outcome, while a score of 1 reflects a good result. The sum of the 6 categories represents the final score.

   The adhesive-sutured patients completed a questionnaire regarding their satisfaction with its use. The 5-0 nylon-sutured patients also completed a questionnaire regarding the merits and demerits of the classical suture method. This questionnaire used the visual analogue scale (VAS) and open-ended questions (Table 1). [3]

   Chi-squared test, Mann-Whitney test, and the Wilcoxon signed rank test were used with SPSS software program (SPSS Inc, Chicago, Ill); P < 0.05 was considered statistically significant.

Results

   Fifty-two patients (29 men, 23 women) were enrolled in this study (mean age: 17.3 years; SD: 14.6 years). Six patients underwent both preauricular fistulectomies: 4 patients in the adhesive-sutured group and 2 patients in 5-0 nylon-sutured group.

   Thirty-three patients, 15 males and 18 females, with a mean age of 12.6 years (SD: 14.7 years), were treated with the tissue adhesive. Nineteen patients, 8 male and 11 female, with a mean age of 14.6 years (SD: 13.8 years), were sutured with an interrupted 5-0 nylon suture material (Ethicon Inc, Somerville, NJ) consisted of 8 males and 11 females (mean age: 14.6 years; SD: 13.8 years). There was no significant difference between age and sex in the two groups (P = 0.983 and 1.000, respectively).

   Cosmetic outcome; Hollander Wound Evaluation Scale. The mean HWES score for patients treated with the adhesive was 4.3 (SD: 0.6). The mean score for patients treated with an interrupted 5-0 nylon suture closure was 4.0 (SD: 0.9). There was no significant difference of the HWES score between these groups (P = 0.668).

   Questionnaire.< Regarding general satisfaction (question on page 1 of questionnaire), the mean VAS score was 9.4 (SD: 0.6) for patients treated with the tissue adhesive and the mean VAS score was 9.5 (SD: 0.7) for patients treated with an interrupted 5-0 nylon suture closure. There was no significant difference in the VAS scores between groups (P = 0.742).

   The second question (page 2 of questionnaire) was asked again to both groups after patients were shown a picture of a wound that was sutured with 5-0 nylon and the associated postoperative course explained. As a result, the mean VAS score of the adhesive-sutured group improved to 9.8 (SD: 0.7). However, there was no significant difference between the score for the adhesive-sutured group and the 5-0 nylon-sutured group (P = 0.210).

   Among 33 tissue adhesive-sutured patients, the ability to wash their face or to shower/bathe soon after the procedure was seen as a merit by 28 patients, the lack of any frequent dressing or wound care by 21 patients, and the lack of skin sutures by 19 patients. The ability to conceal the surgical wound with make-up was especially praised by 8 young women.

   After 19 of the 5-0 nylon-sutured patients saw a picture of a wound that was sutured with the tissue adhesive and knew the differences in the postoperative care, 12 patients decided to consider the use of the tissue adhesive in future surgery. In the 9 cases of 5-0 nylon-sutured children, their parents wanted it to be used. They explained that their young children often contaminated the dressing, that it was too stressful to change the dressing or to remove sutures of scared/anxious children, and that it was too difficult to shower, bathe, or to wash hair with a gauze dressing. Five male patients complained that their busy work life did not allow enough time to visit the hospital for frequent dressing change. Two female office workers who met with business clients frequently felt an overwhelming sense of shame by the display of the gauze dressing.

   Complications. There were no cases of contact dermatitis. Wound complication was noted in 4 tissue adhesive-sutured patients. Wound dehiscence developed in 2 patients, but was healed by conservative dressing without complication. In 2 patients, a stitch abscess was noted. The tissue adhesive coat over the abscess was removed, skin approximation was widened, and the abscess was evacuated. The stitch abscess and dehiscence were healed without complication. Wound complication developed in 2 cases in the 5-0 nylon-sutured group; seroma and resultant wound dehiscence in 2 cases were healed by seroma evacuation and skin re-suture. Wound complication rates did not differ between groups (P = 0.941).

Discussion

   Cyanoacrylate adhesives were first synthesized in 1949, and first used clinically 10 years later. These liquid monomers polymerize via an exothermic reaction when exposed to a fluid or basic medium, and thereby form a strong bond when applied to skin.^1,5–8

   Cyanoacrylate derivatives differ according to the length of their carbon chain and initial formulations used short-side-chain alkyl groups, such as ethyl or methyl groups. The main disadvantage of cyanoacrylates is that they degrade into the histotoxic byproducts, such as cyanoacetate and formaldehyde. These toxic byproducts can induce an acute and chronic inflammatory response in the surrounding tissues, potentially compromising wound healing. Since shorter carbon chain cyanoacrylate derivatives have a more rapid degradation time and release larger quantities of toxic byproducts to surrounding tissues, these cyanoacrylates have not been used clinically.^1,7,8 Subsequently, longer-chain derivatives, such as butyl and octyl, have been developed and degrade more slowly, causing less local toxicity and decreased inflammation. In 1970, butyl-2-cyanoacrylate (Histoacryl®, Braun, Melsungen, Germany) was developed, which had negligible toxicity and a good tissue seal. For a number of years, butyl-2-cyanoacrylate had been used for wound closure, but less strength and flexibility have limited its use.^1,5–7

   Octyl-2-cyanoacrylate is an 8-carbon alkyl derivative that has a breaking strength 3 to 4 times that of butyl-2-cyanoacrylate.^1,5 The US Food and Drug Administration (FDA) approved the use of octyl-2-cyanoacrylate for superficial skin closure in 1998.¹ The tissue adhesive is maintained in the liquid state by an acidic stabilizer, preventing premature polymerization. Upon application, partially ionized water molecules on the skin surface neutralize the stabilizer, thereby allowing polymerization to occur, usually within 10 seconds. Its breaking strength approximates that of a 5.0 monofilament nylon suture, while its plasticizers form flexible bonds. The flexibility of octyl-2-cyanoacrylate allows for nonlinear incisions, and contributes to a decrease in the tension exerted on the skin from movement. It may be used in combination with intradermal or subcutaneous sutures, but not as a substitute. For this reason, it has been used in a wide variety of clinical settings including laparoscopic surgery, orthopedics, plastic surgery, ophthalmology, otorhinolaryngology, and vascular surgery. A recent in-vitro study has shown that octyl-2-cyanoacrylate is effective as an antimicrobic barrier for the first 72 hours after application.⁷ The skin formed by octyl-2-cyanoacrylate is an effective barrier against [4]Gram-positive and Gram-negative bacteria, including Staphylococcus epidermis, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecium. It also creates a protective layer for the wound and keeps the area moist, thus favoring faster re-epithelization. Its application is simple and fast, even in the case of very large wounds.^1,7,8

   Cyanoacrylate adhesives have several potential benefits over sutures, including ease of use, painless application, rapid closure, cosmesis, avoidance of needle injuries and removal of the suture or staples. It reaches a maximum bond strength in 2.5 minutes, creates a barrier, and renders the wound waterproof. It allows patients to shower normally without soaking or scrubbing the surgical site; its waterproof quality is one of the merits patients found particularly favorable. For patients who undergo office-based outpatient surgery and have difficulties in performing frequent dressing changes, the lack of a dressing is also an important merit. Children undergoing skin closure with the tissue adhesive do not have to undergo stressful dressing or suture removal since wound examination can be done through the clear polymer covering. Both the children and their parents have commended these conveniences.⁸

   It is critical to keep in mind that the main disadvantage of this tissue adhesive is its local histotoxicity. Toxic byproducts of cyanoacrylate degradation, such as cyanoacetate and formaldehyde, accumulate in the surrounding tissues. Although the tissue adhesive has a long degradation time and the slower release of toxic byproducts has the benefit of lower concentration of toxic byproducts in the surrounding tissues, the potential for a local inflammatory response exists. Additionally, the potential for an acute inflammatory response caused by the histotoxic byproducts in subcutaneous tissues limits its usage for any application below the epidermal level.¹

   Generally, cyanoacrylate adhesives are not recommended for patients with insulin-dependent diabetes, peripheral vascular disease, blood clotting disorders, or collagen vascular disease. Because there is no protection against keloid formation, they should not be used in patients with a history of keloid formation or a tendency to form hypertrophic scars. Patients with a known history of an allergic response or contact dermatitis to formaldehyde should not use cyanoacrylate adhesives.¹

   The ideal application for cyanoacrylate adhesives is on a clean, linear laceration. Certain wounds are deemed inappropriate for the use of a cyanoacrylate tissue adhesive. Decubitus ulcers, animal or human bites, or wounds with evidence of gross bacterial contamination or infection, are contraindicated for cyanoacrylate tissue adhesives. In complex lacerations or wounds with excess tension, the traditional suture method is preferred over the use of cyanoacrylate adhesives. Wounds with an unfavorable skin edge bevel are closed more precisely with vertical mattress sutures that can evert the epidermal skin edge maximally. Wounds that are on hair-bearing skin or mucosa are closed best with sutures.¹

   Contrary to the use of the traditional suture method, cyanoacrylate tissue adhesives tightly seal the skin and cut off the internal wound from the outside. Therefore, it is very important to obtain meticulous intraoperative bleeding control and to eliminate dead space using subcutaneous sutures. This decreases the likelihood of wound infection and wound tension, and facilitates skin-edge eversion. If an unwanted seroma or hematoma develops, it is difficult to evacuate them by removing 1 or 2 stitches and widening the incision. Generally, it is recommended that surgeons do not completely cover the wound with the cyanoacrylate tissue adhesive in cases where hemostasis is an issue. In these cases, a single suture is placed at the end of an incision without adhesive coverage, allowing for the discharge from a seroma or hematoma.¹

   The tissue adhesive usually remains on the wound for 7 to 14 days after its application, and then sloughs off with the desquamating epidermis.¹

   Two limitations must be considered in relation to this study. Despite the many advantages of adhesive use, there was no improvement in cosmetic outcomes in this study. An improvement in cosmetic outcome has only been noted in studies with a larger number of patients. The second limitation to the adoption of cyanoacrylate tissue adhesive application was the cost. Although the cyanoacrylate tissue adhesive costs 50 times as much as the 5-0 nylon suture material, the tissue adhesive sutured patients paid 2.5–7.0 times as much as 5-0 nylon-sutured patients. However, if one compares the total medical cost rather than the individual patient payment, the difference was reduced to 1.7–4.7 times (Table 2). In addition, considering the indirect social costs including economic loss or transportation costs not counted in this calculation, it is expected that a difference in expenditures between the two methods might be much less than estimated. Additionally, patients’ paradigm shift is the principal reason why most patients want to use the tissue adhesive regardless of cost. Recently, patients’ desire for improved quality of life has increased rapidly, and many patients want a comfortable and pleasant medical treatment. Korean national health insurance also reduces individual patient payment, which makes the tissue adhesive an attractive option.

   The risk of contact dermatitis is an important consideration for clinicians. Contact dermatitis or hypersensitivity is rare. In their study, Cohen and Kaufmann⁹ ascribed contact dermatitis to common medical acrylics, such as commonly used bone and dental cement, to 1.6% of patients with suspected contact dermatitis. Also, in contrast to the toxic reaction in vitro, there is no evidence of histotoxicity in in-vivo studies on animals after correct adaptation of the wound edge.⁵

Conclusion

   Dermabond tissue adhesive provides a means of closure of preauricular fistulectomy wound closure equivalent to traditional suture closure. The use of a tissue adhesive is preferable for children who undergo a preauricular fistulectomy, considering children frequently contaminate the wound dressing, find it is too stressful to change the dressing or undergo suture removal, and find it difficult to shower, bathe, or wash hair with a gauze dressing. Its use is suitable for the busy professional who does not have time for a hospital visit, and young women who dislike unseemly gauze dressing.

From the Department of Otolaryngology–Head and Neck Surgery, The Catholic University of Korea, Seoul, Korea