Initial experience with hemostatic fibrin glue as adjuvant during drainless parotidectomy

Abstract

Objectives

To evaluate the use of Hemostatic Fibrin Glue in parotidectomy without the use of surgical drains.

Study design

Prospective cohort study of 10 patients undergoing parotidectomy. Surgery as a one day admission without the use of surgical drains was planned. The complication and duration of the hospital stay were obtained.

Methods

Parotidectomy was undertaken by one surgeon. Prior to wound closure, the skin flap and wound bed were approximated using Tisseel tissue sealant. Data regarding the incidence of any complication and the duration of the hospital stay were obtained. Patients were followed to assess surgical outcome and document any complications. The mean follow-up period was 8 months (range 4–12 months).

Results

There were no major surgical complications. Two patients had facial nerve weakness due to adherence of the tumour in the facial nerve, in there was which complete recovery after few months. All patients were discharged the next day. None of the patients felt that the discharge had been premature.

Conclusions

Parotidectomy can be undertaken safely without the need for surgical drains, therefore, allowing the patients to leave the hospital on the first postoperative day.

1. Introduction

Parotidectomy is the definitive diagnostic and management procedure for most parotid masses (Folia, 2003; Das, 2004). Owing to the rich vascular supply to the parotid area, as well as the possibility of salivary leakage from incised parotid tissue, traditional postoperative management for parotidectomy patients in many institutions includes the use of a percutaneous drain.

Percutaneous drains have a wide spectrum of associated complications, including infection, fistula formation, discomfort, psychosocial impact, and failure secondary to plugging, resulting in fluid accumulation (Reid, 2003). In some institutions, the persistence of a percutaneous drain is an indication for a patient to remain admitted postoperatively (Steckler, 1991).

Initial testing of tissue sealant consisting of fibrinogen and thrombin was undertaken by Young and Medawar (1940). During the past two decades, the idea of using fibrin glue as a biological adhesive has gained popularity in various surgical procedures including microneural repairs (Kuderna et al., 1979), otolaryngologic surgery (Staindl, 1979), craniofacial surgery (Marchac and Renier, 1990), and aesthetic surgery (Bruck, 1982; Ellis and Pelausa, 1988; Mandel, 1990; Marchac and Sandor, 1994).

Fibrin glue aids hemostasis by mirroring the final common pathway of the coagulation cascade and facilitates the close apposition of surfaces for healing. These biological effects allow a rapid healing with decreased rate of postoperative complications and improve the final cosmetic results. With new techniques comes the opportunity to consider alternative postoperative management approaches with specific surgical procedures.

The Tisseel components are sterilized through a dry heat and vapour heat protocols, and all donors are screened for communicable diseases. To date, there have been no reported or suspected cases of Tisseel-mediated transmission of any communicable diseases, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or Creutzfeldt–Jakob disease (Joch, 2003).

Tisseel is a commercially available fibrin glue product that has been used previously to reduce or eliminate the need for a percutaneous drain in facial cosmetic surgery (Staindl, 1979; Bruck, 1982; Marchac and Sandor, 1994; Marchac et al., 1987). It is composed of human-derived thrombin and fibrinogen, as well as bovine-derived aprotinin, which function to form a fibrin mesh in vivo independently from the proximal coagulation cascade of either the intrinsic or the extrinsic pathway. This mesh binds host platelets to form a thrombus, which is stable for approximately 10–14 days in humans.

In the case of parotid surgery, it is possible to consider using tissue glues to replace the need for surgical drains. Without surgical drains, the need for planned prolonged admission (>1 day) for the monitoring of drainage, associated nursing care and bed availability issues can be reconsidered.

This prospective study evaluates the use of tissue glue in drainless parotid surgery, which evaluates the duration of hospital stay and postoperative complication rate in parotidectomy patients with the use of Tisseel.

2. Materials and methods

A prospective and consecutive cohort of 10 patients underwent parotidectomy with facial nerve preservation (without neck dissection) between March 2009 and November 2009 at King Abdulaziz University Hospital, Riydah. In this cohort, 2 patients underwent partial parotidectomy, 6 had a superficial parotidectomy and 2 had a total parotidectomy. The cohort consisted of 6 males and 4 females with a median age of 39.8 years (range 16–57 years). Nine of these patients had a presumed benign disease process based on clinical findings and investigations, including fine-needle aspiration cytology and imaging (CT). The surgery was planned as a overnight stay without the use of surgical drains.

2.1. Surgical protocol

A standard, modified Blair parotidectomy incision was used for each patient. A superficial musculoaponeurotic system platysmal flap was raised. The parotidectomy procedure was performed in a standard fashion. Following excision of the lesion, meticulous hemostasis was obtained.

A slow-setting mixture of fibrin tissue glue was prepared according to the manufacturer’s instructions. The preparation used contains 500 IU/mL of human thrombin. Two milliliters of the fibrin glue was applied to the wound bed. The glue was delivered to the area by a spray device (Duploject spray set and Tissomat spray device, Baxter Corp.).

The skin flap was reapproximated to the wound bed, and sustained pressure was applied for 5 min. The superficial skin was then closed using a running absorbable suture. No drain was used. All patients were discharged first day post surgery. Patients were followed to assess the surgical outcome and document any complications. Patients were initially reviewed 10 days after their surgery. Any complications were documented, as well as their experiences regarding the surgery. The mean follow-up period was 8 months (range 4–12 months).

2.2. Data collection

The incidence of postoperative complications such as hematoma, salivary fistula, wound dehiscence, necrosis, and facial nerve paralysis were noted for all patients. The length of hospital stay was noted for all the patients.

2.3. Statistical analysis

Statistical analysis was performed using SPSS, version 15.0 for Windows.

3. Results

Ten patients were enrolled in this study. The demographics of study patients are outlined in Table 1. The cohort consisted of 6 males and 4 females with a median age of 39.8 years (range 16–57 years). The mean follow-up period was 8 months (range 4–12 months).

Table 1.

Patient demographic information.

Total number	10
Mean age	39.8
Male	6
Female	4
Tail	2
Superficial	6
Deep	2

In this cohort, 2 patients underwent partial parotidectomy, 6 had a superficial parotidectomy and 2 had a total parotidectomy. The surgical technique of identifying the facial nerve were either antegrade (50%) or retrograde (50%) technique Table 2.

Table 2.

Type and technique of surgery.

Partial parotidectomy	2
Superficial parotidectomy	6
Total parotidectomy	2
Antegrade technique	5
Retrograde technique	5

Nine of these patients had a presumed benign disease process based on clinical findings and investigations, including fine-needle aspiration cytology and imaging Table 3.

Table 3.

Histopathology type.

Pleomorphic adenoma	8
Lipoma	1
Sebacous Ca	1

There were no cases of seroma, hematoma, flap necrosis, salivary fistula or prolonged facial weakness. However, there were two patients who had facial nerve paresis post operatively, in which the facial nerve function came back to normal after few months. Of these two patients, one had partial parotidectomy and the marginal mandibular nerve was adherent to the tumour, in which the dissection of the nerve to separate it from the mass caused a mild weakness. In the other case, patient had a deep lobe tumour, in which the dissection of the nerve of the deep lobe mass caused a mild weakness in the lower branches.

Absence of cosmetic sequelae (facial paralysis and ecchymosis or edema) and infection at the time of removal of dressings permitted all patients to return to a normal life within 5 days after surgery.

In this cohort, all patients were discharged the next day. All patients expressed satisfaction with their surgery. No patients felt that the discharge had been premature.

4. Discussion

Within the specialty of otolaryngology-head and neck surgery, tissue glue has been used in several situations, including facial plastic surgery (Anderson and Baker, 2003), thyroidectomy (Matthews and Briant, 1991; Lachachi et al., 2000), nasal septal surgery (Daneshrad et al., 2003), tonsillectomy (Viaman et al., 2003), and more complex head and neck surgery (Kang et al., 1998; Wiseman et al., 2002; Yoshimura and Kondoh, 2002).

The goal of parotid surgery is the eradication of disease with minimal morbidity thereby allowing the patient to return rapidly to normal living. During the last decade, the use of alternate incisions (Cohen, 1988; Ferreria et al., 1990), and filling of volume deficits with transfer of tissues such as sternocleidomastoid muscle (Bugis et al., 1990), free fat grafts (Nosan et al., 1991; Harda et al., 1993), or SMAS applications (Rappaport and Allison, 1985), resulted in acceptable cosmetic results, but did not show any significant reduction in the immediate postoperative morbidity. Postoperative wound bleeding, hematoma, and salivary fistula were commonplace after parotidectomy (Matory and Spiro, 1993; Wax and Tarshis, 1991).

There are different concentrations of thrombin available for use in Tisseel. The one used in this study is the fast-setting thrombin 500 IU/mL concentration, which functions more as a hemostatic agent and a glue. The thrombin 4 IU/mL concentration takes 1–2 min to set and functions more as a sealant. Although the thrombin 4 IU/mL concentration has been used successfully in facial cosmetic surgery in the past, the thrombin 500 IU/mL concentration is used in this study because the instant hemostatic and glue properties were more likely to be effective in the parotidectomy wound bed. In addition, the duploject syringe application method was used because it provides a more controlled and directed application of the Tisseel than the available spray attachment.

The potential for use of tissue sealant in patients undergoing parotid surgery has been reported in a French cohort of 34 patients (with a same-sized cohort not receiving fibrin tissue glue) by Depondt and colleagues (1996). The patients in the fibrin glue group initially received a surgical drain, a practice that was abandoned during the study. The patients all stayed in hospital at least one night, and all patients had pressure dressings applied that were maintained until the fifth postoperative day. The authors suggested that there were significantly fewer complications in the cohort that received tissue glue and in particular in those patients developing a major hematoma. The numbers in the statistical comparisons were small, and the rate of major hematoma recorded in the non–tissue glue group was high (15%) compared with no major hematomas in the tissue glue cohort, so the statistical result must be viewed with caution. In this study, there were no cases of hematoma.

A more recent randomized, controlled study compared drainage volumes and the incidence of seromas between a group of patients that received Tisseel to the parotid bed and a group that did not. Maharaj and colleagues (2006) concluded that the use of tissue glue significantly decreases both the total drainage volume and the frequency of postoperative seroma. This study differs in that it challenges the assumption that a surgical drain is required for parotidectomy surgery.

Prompted by the beneficial results reported with fibrin glue in face-lift procedures (Marchac et al., 1987), I used the tissue adhesive for parotidectomy closures and noted a significant reduction in the rate of postoperative complications. There was a decrease in the overall incidence of hematomas. Marchac and Sandor (1994) believed that the fibrin glue traps and limits the spread of bleeding, producing minor instead of major hematomas, allowing them to be treated by simple aspiration. However, in this study there were no major nor minor hematomas.

Contrary to the opinion of Ellis and Pelausa (Ellis and Pelausa, 1988) that saliva may inactivate or degrade the fibrin glue. Depondt and colleagues (1996), salivary fistulae were noted in 2 of 34 patients treated with fibrin glue, and these fistulae occurred typically at the exit of the drains. In my study salivary fistula was not noted in any of the patients treated. Surprisingly, no fistulae were noted since the omission of drains from 1994 onwards. We believe that drains promote salivary fistulae by allowing the secretions to drain externally. In contrast, total omission of the drain permitted fibrin glue to completely seal the flap to the deep tissues, leaving no pockets and preventing the occurrence of salivary fistulae (Depondt et al., 1996).

Depondt and colleagues (1996) observed in their study that postoperative facial paralysis was always associated with a major hematoma in the group of patients who had traditional parotidectomy closure, whereas this complication was completely absent in the fibrin glue-treated group. However, in my study, the two postoperative facial nerve pareses were due to the adherence of the tumour to the marginal mandibular nerve, in which the dissection of the nerve to separate it from the mass caused a mild weakness in one case, and in the other case, the patient had a deep lobe tumour, in which the dissection the nerve of the deep lobe mass caused a mild weakness in the lower branches. Therefore, I do not believe that the hemostatic action of the fibrin glue may reduce the risk of facial nerve paralysis by decreasing the risk of hematoma formation.

Steckler (1991) first reported the feasibility of performing outpatient parotidectomy. Despite rigorous preoperative selection, 10 of his 54 patients were readmitted for the treatment of complications. In my study, I used fibrin glue for closures after resection of benign and malignant parotid lesions and observed a marked reduction in the complication rate. Parotidectomy without drains permitted all patients to leave the hospital on the first postoperative day. No patient required readmission for the treatment of a complication.

The trend over the past 30 years has been to perform more surgery on a day surgery basis. Medical insurance providers are keen to reduce costs and may have helped drive this trend to increased day surgery through their reimbursement policies of the costs related to hospital stays. This effect is likely to continue as operations that were once considered to need overnight hospital admission had begun to be undertaken more routinely as daycare procedures.

The current cost of Tisseel in Saudi Arabia is approximately $350/mL, bringing the cost for intervention per patient to approximately $700. The decrease in the complication rate demonstrated in this study justifies this cost.

5. Conclusions

Hemostatic actions of fibrin glue precluded the necessity of usage of drains, also, it resulted in decrease in the volume of postoperative wound drainage and the frequency of postoperative hematoma and seroma. Parotidectomy can be undertaken safely in a day surgery setting without the need for surgical drains, therefore, allowing the patients to leave the hospital on the first postoperative day.

The future research will be doing the parotidectomy without drains as day surgery, so the patient can be discharged in the same day of the surgery, and this will solve the problem of bed shortage in some of the hospitals.

That will lead to the reduction in cost of the day surgery compared to hospital stay. Therefore, Medical insurance providers are keen to reduce costs and may have helped drive this trend to increased day surgery through their reimbursement policies of the costs related to hospital stays.