Evaluation of isoamyl 2-cyanoacrylate tissue adhesive in management of pediatric lacerations: An alternative to suturing.

AIMS: A study was conducted to evaluate the benefits of cyanoacrylate tissue adhesive as an alternative to suturing in management of pediatric lacerations.
MATERIALS AND METHODS: A total of 7 patients were evaluated and followed for 3-month. The wound was evaluated on 1(st), 3(rd), and 7(th) postoperative day for swelling, infection, gaping and pain and at 1(st) and 3(rd) postoperative month for scar evaluation. The evaluation was based on different superficial facial wound repairs (i.e., low tension) with an average length <3 cm; and if the surgeon subjectively felt that subcuticular sutures were justified to reduce wound tension, then these were used. Isoamyl 2-cyanoacrylate glue was applied over lacerated wound margins after cleaning the wound and holding together for 15 s by means of tissue holding forceps. STATISTICAL ANALYSIS: Statistical analysis was done using Chi-square test after collection of data. Mean and standard error were estimated from the sample.
RESULTS: The mean total time taken for skin closure was 1-2.5 min. There was no wound infection in any of the cases; only one case showed wound dehiscence on 3rd postoperative day. The cosmetic was better as there were no suture marks.
CONCLUSION: Isoamyl 2-cyanoacrylate can be considered as excellent "no needle" alternative for closure of selected pediatric lacerations, those that are short, clean and under low tension.

INTRODUCTION

Lacerations requiring wound closure account for 30–40% of all pediatric injuries. The thought of needles, sutures or staples may be worse than the actual injury itself to a child patient. Therefore, the ideal method of wound closure in children should be not only painless but also rapid, easy to perform, safe, with few complications and should result in minimal scarring. Closures with conventional suturing techniques entirely fail to accomplish all these goals. The aim of this study was to evaluate the benefits of cyanoacrylate tissue adhesive as an alternative to suturing in management of pediatric lacerations.

MATERIALS AND METHODS

A prospective in vivo study of seven patients requiring wound closure after laceration in oral and maxillofacial region was conducted after getting the ethical committee clearance. Children with suitable lacerations were allocated for wound closure with isoamyl 2-cyanoacrylate.

Wounds considered for inclusion into the trial were simple lacerations that required closure, in children aged between 1 and 14 years of age. The evaluation was based on different superficial facial wound repairs (i.e., low tension) with an average length <3 cm; and if the surgeon subjectively felt that subcuticular sutures were justified to reduce wound tension, then these were used. Explanation was provided, and signed consents were obtained prior to treatment.

Specific exclusion criteria included situations where the patients had infected wounds, or with a history of any keloid, and allergy to cyanoacrylates.

Novocryl glue, an isoamyl 2-cyanoacrylate used in this study is available as single-use 0.25 ml and 0.5 ml ampoule from Alkem Laboratories Limited and manufactured by Concord Drug Limited. Novocryl is a sterile, inert, nontoxic, biodegradable, biocompatible and bacteriostatic liquid topical adhesive [Figure 1].

Figure 1

Novocryl glue – Isoamyl-2-cyanoacrylate

The length of the laceration was measured with the help of a divider and an mm graded scale. Isoamyl 2-cyanoacrylate glue was applied over lacerated wound margins after cleaning the wound and holding together for 15 s, by means of tissue holding forceps. The glue turns opaque signifying the completion of polymerization. The applied film was kept thin. The time required for the skin closure was also noted. Though dressings are not recommended by the manufacturer, a sterile gauze dressing was given to prevent any accidental damage to the closed wound.

Patients were evaluated and followed for 3-month. The wound were evaluated on 1st, 3rd and 7th postoperative day for swelling, infection, gaping and pain and at 1st and 3rd postoperative month for scar evaluation [Figures 2–7].

Figure 2

Case 1 – Laceration on right cheek

Figure 7

Case 2 – Immediate postoperative

Case 1 – Immediate postoperative after application of novocryl

Case 1 – 4th week postoperative

Case 1 – 3rd month postoperative

Case 2 – Laceration on chin

The clinical parameters, that is, swelling, infection and gaping were evaluated as absent or present “0” and “1” respectively. Exudate was assessed from the dressing given previously. Infection was suspected in all cases with severe exudation, pus discharge, and high temperature. Gaping was measured with the help of divider and mm graded scale. Severity of pain perception was assessed via simplified Visual Analogue Scale (VAS)[12] of 100 mm in length where ‘0’ marked as “no pain” and “100” as “severe pain.”

The wound was assessed for cosmesis on 1st and 3rd postoperative month. Hollander Cosmesis Scale looks at the presence of 6 clinical variables as step-off borders, edge inversion, contour irregularities, excess inflammation, wound margin separation, good overall appearance. A total cosmetic score was derived by adding the scores of variables. A score of 1 is given to each variable if not present in the wound, so a score of 6 was considered as optimal while 5 or less as suboptimal.[34567] Parent satisfaction with wound cosmesis was recorded at the same time on a 100-mm VAS (0 = worst scar, 100 = best scar).[4891011]

RESULTS

Statistical analysis was done after collection of data. Mean and standard error were estimated from the sample. Children with suitable lacerations were allocated for wound closure with isoamyl 2-cyanoacrylate. A total of seven patients were evaluated and followed for 3-month.

The mean age of the patient was 6.35 ± 1.36 years (2–12). There were 5 (71.43%) boys and 2 (28.57%) girls. Mean length of the laceration ± standard error of the mean was 1.43 ± 0.13 cm. The mean total time for skin closure was 1.57 ± 0.17 (1–2.5) min [Table 1].

Table 1

Demography and baseline data of patients

Wounds were evaluated for signs of infection, depending on presence or absence of pus. None of the cases showed wound infection on 1st, 3rd, and 7th postoperative day. Only one case showed wound dehiscence on 3rd postoperative day. Swelling was present postoperatively in all cases on 1st, and 3rd day. On 7th postoperative day swelling was present in two cases [Table 2 and Graph 1].

Table 2

Patients having swelling and complications after treatment

Graph 1

Percentage of patients having swelling after treatment

The postoperative pain was measured using VAS by patients themselves. VAS is calibrated from 0 to 100. There were significant changes on 1st, 3rd, and 7th postoperative day by analysis of variance; P < 0.05 [Table 3 and Graph 2].

Table 3

Mean scores for pain using 0-100 VAS

Graph 2

Mean (standard deviation) Visual Analogue Scale scores for pain

Patients were followed-up at 1st month, and 3rd month and the wound was assessed for cosmesis using Hollander Cosmesis Scale and VAS, calibrated from 0 to 100.

The minimum wound cosmesis using Hollander Cosmesis Scale score was 5, and a maximum score was 6 with a mean of 5.87 ± 0.14.

Parent satisfaction with wound cosmesis was recorded on a 100-mm VAS. At 1-month; the minimum score was 60, and a maximum was 90 with a mean of 81.43 ± 4.59, and at 3-month minimum was 70 and maximum was 100 with a mean of 88.57 ± 4.04. This difference was statistical significant with P > 0.05 [Table 4 and Graph 3].

Table 4

Mean values for Hollander and Cosmesis scale

Graph 3

Mean cosmesis Visual Analogue Scale score

DISCUSSION

Discovery of cyanoacrylates by Ardis in 1949[12] and subsequent use of this material in surgery by Coover et al. in 1959[13] revolutionized nonconventional suturing technique. Isoamyl 2-cyanoacrylate is an advanced gamma sterilized, nonpigmented, nontoxic, nonallergic, and biostatic tissue adhesive. It helps in rapid wound closure with minimal scarring, and reduces the risk of postsurgical infection and trauma, apart from being simple to use, and showing a demonstrable safety,[14] thus providing effective wound healing with minimal risk. The mechanism with which isoamyl 2-cyanoacrylate acts is by getting converted into a polymer on coming in contact with moisture, and though, by itself, it is an inert material, it solidifies rapidly within 5–10 s.

In our study, a total of seven patients were treated for lacerated wound closure with isoamyl 2-cyanoacrylate. Various parameters like swelling, infection, gaping, pain and scar were included to study the outcome.

Many papers have shown good cosmesis and rapid time for a laceration closure using glue.[1516171819] Pain was one of the most serious reasons for anxiety in patients and parents. The other factors could be explained as a stressful environment and separation of the children from the parents. Isoamyl 2-cyanoacrylate was applied on small children while they lay on the lap of the parents, and the parents lay on stretchers so as not to distribute their trusted feeling. There was generally no need for local anesthesia injection, which were essential for the traditional wound repair on children. In the study by Matin, the mean time taken for skin closure in adhesive glue group is faster than skin suturing group (150 s vs. 360 s)[10] In the present study, the mean time taken for skin closure was 1.57 ± 0.17 min, which is much faster and time saving.

There are varying reports regarding the antibacterial properties of cyanoacrylate glue.[20] The glue has a bacteriostatic effect against Gram-positive bacteria while no activity has been reported against gram-negative bacteria.[21] There have been no reports of any carcinogenic effects.[22] In the present study, none of the cases showed wound infection at 1st, 3rd, and 7th postoperative days. Ong et al. in their study observed that there was no incidence of wound infection in any of the cases in glue and suture group,[11] whereas Rosin et al.[23] reported a case of wound infection with N-butyl 2-cyanoacrylate, and he relates it to the improper approximation of the wound edges.

Higher cyanoacrylates like N-butyl-2-cyanoacrylate and isoamyl 2-cyanoacrylate degrade at a slower rate than those with shorter side chained ones. These materials are less histotoxic due to their slow degradation.[24] As they breakdown slowly it is not advisable to apply a multiple continuous layers between two tissue surfaces. The tissue edges should be approximated before the adhesive is applied over the junction. When the edges are improperly approximated, adhesive material may enter into the wound thereby interfering with edge approximation leading to wound dehiscence. Many studies reported the incidence of wound dehiscence with N-butyl-2-cyanoacrylate. Qureshi et al. reported two of 102 cases of partial dehiscence after general and laparoscopic surgeries, and he related its occurrence due to the inadequate drying of the skin edges before the application of the adhesive.[25]

Ong et al., compared tissue adhesive 2-octylcyanoacrylate and suture for closure of surgical incisions in children and reported none of the cases with wound dehiscence.[11] In our study, only one case showed wound dehiscence on 3rd postoperative day which could have been due to inadequate undermining and approximation of the tissue edges. Swelling seen in all patients on 1st, and 3rd postoperative day can be related to injury trauma.

Pain was assessed at 1st, 3rd and 7th postoperative day using VAS of 0-100 mm, as rated by the patient themselves. In the present study, pain was significantly less on 7th postoperative day. The reasons for the reduced postoperative pain may be due to the thin layer of flexible polymer shielding the wound from all the physical agents such as air current and it is also possible that formaldehyde which is one of the degradation products of cyanoacrylate may be absorbed in minute quantities causing a local anesthetic effect at the distal nerve endings. The earlier studies by Zempsky, et al., Arunachalam et al., and Quinn et al., have compared the postoperative pain using VAS of 0-100 and have shown less postoperative pain in adhesive glue group but of no significance.[1112]

Quinn et al. compared 1-year cosmetic outcome of wounds treated with octylcyanoacrylate tissue adhesive and monofilament sutures and correlated the early, 3-month, and 1-year cosmetic outcomes. He found no difference in the cosmetic outcomes of traumatic lacerations treated with octylcyanoacrylate tissue adhesive and sutures.[7]

In the present study, at 3rd month postoperatively the scar was esthetically highly satisfactory as compared to 1st month on Visual Analogue Cosmesis Scale. The scar was thin and supple. Patient's family acceptance was noteworthy and reacted favorably to having the wound closed by the nonsuture technique. Pain and discomfort at the site of the laceration were considerably less as judged by the verbal response of the patients. All patients were spared of the fear and pain of suture removal. No skin reaction to the glue was noted in any case. Cyanoacrylate tissue adhesive was found to be an effective alternative replacing skin sutures employed in low-skin tension wound management.

CONCLUSION

The cyanoacrylate tissue adhesive isoamyl 2-cyanoacrylate are excellent “no needle” alternative for closure of selected pediatric lacerations, those that are short, clean and under low tension. Cyanoacrylates have a number of advantages over conventional suture like their fast and painless application, rapid setting which reduces the total quality time, their antibacterial properties. Cyanoacrylate itself acts as a water proof dressing and helps in reduction in the number of follow-up visits. As they do not require any needles, accidental needle stick injuries are prevented. However, there are certain disadvantages of cyanoacrylates like their less tensile strength and chances of the adhesive seepage if edges are not properly approximated.

In this study, it has been observed that the efficacy of cyanoacrylate in the closure of surgical wounds is comparable to the previously quoted studies.

Despite the encouraging advantages of the tissue adhesives, it is important to remember that wound closure is only part of the wound management in these children. Many wounds require irrigation, debridement, and deep sutures, which may require time, conscious sedation or anesthesia.

In summary, the use of isoamyl 2-cyanoacrylate is easy, and safe, with no complications, and results in equally good cosmesis. It is a viable alternative in areas such as the head, neck and face where a dressing is unsightly or difficult to apply.