- Email: [email protected]
Autologous fibrin tissue adhesive in endoscopic sinus surgery
Autologous fibrin tissue adhesive in endoscopic sinus surgery LYON L. GLEICH, MD,* ELIEE. REBEIZ,MD, MICHAIL M. PANKRATOV,MS, and STANLEYM. SHAPSHAY,MD, Burlington, Massachusetts Endoscopic sinus surgery may be complicated by bleeding, formation of synechia, and infection. This study investigated the application of autologous fibrin tissue adhesive during endoscopic sinus surgery in an attempt to avoid packing, to decrease complications, and to improve healing. Fibrin tissue adhesive from pooled human blood is a hemostatic and bacteriostatic agent. Autologous fibrin tissue adhesive avoids the potential infectious and immunologic risks of the pooled blood product. Twelve patients undergoing bilateral endoscopic sinus surgery participated in the study. Phlebotomy and preparation of the adhesive were performed during the procedure. Fibrin tissue adhesive was applied to only one side, with the contralateral side used as a control. Bacitracin ointment was applied to the adhesivetreated side, and packing coated with bacitracin was placed on the contralateral side. Patients were observed for a minimum of 3 months, and results were documented with photographic and video recordings. A uniformly high degree of patient satisfaction was achieved because of the elimination of packing and a sensation of increased nasal airway patency on the fibrin-treated side. Fibrin tissue adhesive provided hemostasis, decreased crusting, accelerated mucosal healing, and diminished synechia. Autologous fibrin tissue adhesive is beneficial in endoscopic sinus surgery, and its application should be considered, especially when the risk of hemorrhage or synechia is increased. [OTOLARYNG©LHEAD NECK SURG 1995;112:238-41 .)
Endoscopic telescopes used in sinus surgery have increased surgical precision, but complications still occur and are often related to bleeding or to scar formation. Application of a substance that is hemostatic and bacteriostatic and that aids the healing of raw surfaces created during the operation should decrease the complication rate. From the Department of Otolaryngology-Head and Neck Surgery and the Eleanor Naylor Dana Laser Research Laboratory, Lahey Clinic. Supported in part by a grant from the Eleanor Naylor Dana Charitable Trust, New York, N.Y. Presented at the Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Minneapolis, Minn., Oct. 2-6, 1993. *Dr. Gleich's current address is New York Eye and Ear Infirmary, New York Medical College, 310 East 14th St., New York, NY 10003. Received for publication Dec. 16, 1993; revisionreceived July 22, 1994; accepted July 29, 1994. Reprint requests: Stanley M. Shapshay, MD, Department of Otolaryngology-Head and Neck Surgery, New England Medical Center Hospitals, #850, 750 Washington Stl, Boston, MA 02111. Copyright © 1995 by the American Academy of OtolaryngologyHead and Neck Surgery Foundation, Inc. 0194-5998/95/$3.00 + 0 23/1/59517 238
Fibrin tissue adhesive manufactured from pooled h u m a n blood has been used successfully in Europe with multiple applications, including neural anastomosis, hemostasis in soft-tissue defects, fixation of skin grafts, sealing of bone and dura, and gastrointestinal anastomosis. 1-3 Fibrin tissue adhesive has two components. The first component is obtained from human plasma and has concentrated h u m a n fibrinogen and factor XIII. The second component contains commercially available thrombin. The mixing of the two components in the presence of calcium causes the conversion of fibrinogen to fibrin. This product is adhesive, is hemostatic, is a p r o m o t e r of wound healing, 1 and is bacteriostatic. 4 Natural fibrinolysis results in complete absorption of sealant. The potential dangers of viral infection and immune reaction have led to the development of methods of preparation of fibrin tissue adhesive from the patient's own blood. 5,6 In endoscopic sinus surgery, fibrin tissue adhesive may improve mucosal healing with a resultant decrease in scar formation and adhesions. Additionally, when used during operation, increased hemostatic control permits better visualization. The hemostatic properties of the adhesive can also
Otolaryngology Head and Neck Surgery Volume 112
GLEICH et al.
Number 2
decrease the need for packing, reducing the risk of infection and improving mucosal healing. Autologous fibrin tissue adhesive was applied to one side in patients undergoing bilateral endoscopic sinus surgery, and the other side was used as a control. Comparisons were made during the operation and during the postoperative period with video recording and photographic documentation to assess the efficacy of fibrin tissue adhesive in endoscopic sinus surgery. METHODS AND MATERIAL
Twelve patients with chronic sinus disease resistant to medical therapy were enrolled in the study from Oct. 1, 1992, to Dec. 31, 1992. The seven men and five women ranged in age from 19 to 58 years (average, 44.6 years). Ten of the patients had prior endonasal surgery, including endoscopic sinus surgery (four patients), intranasal ethmoidectomy (two patients), nasal polypectomy (five patients), septoplasty (three patients), and turbinectomy (one patient). Six of the patients had asthma, and three of these patients had triad asthma. Five of the patients had a history of smoking, and one patient had a history of bleeding after an earlier sinus procedure. Endonasal examination revealed either extensive polyps or scarring in all patients. Computed tomography was obtained in all patients and demonstrated pansinusitis in nine patients, bilateral extensive maxillary and ethmoid disease in two patients, and bilateral frontal and ethmoid disease in one patient. Informed consent for unilateral application of fibrin tissue adhesive was obtained from each patient, and the procedures were performed at the Lahey Clinic with the approval of the institutional review board. The surgical procedures were performed by one surgeon (S. M. S.), and results of video-recorded follow-up visits were evaluated by two additional surgeons (E. E. R. an L. L. G.). General anesthesia was induced, and after intubation, 72 ml of blood was obtained for autologous fibrinogen precipitation. Lidocaine, 1% with epinephrine 1:100,000, was injected intranasaIly for vasoconstriction, and endoscopic sinus surgery was performed. The precipitation of autologous fibrinogen was performed as described by Siedentop et a l / T o eight tubes, each containing 1 ml of 10% sodium citrate, 9 ml of the patient's blood was added. The tubes were centrifuged at 3200 rpm for 10 minutes, and the plasma was separated. To each tube of plasma, 1.3 ml of saturated ammonium sulfate was added. The eight tubes were centrifuged at 3200 rpm for
239
3 minutes. The precipitates were collected in one tube to which 1 ml of 40 mmol/L calcium chloride was added. This formed component one. A 3-ml solution was made by adding 0.5 ml of a 20 mg/ml solution of epsilon aminocaproic acid to 2.5 ml of sterile water; 1 ml of this solution was added to 1000 NIH units of thrombin powder (Armour Pharmaceutical Co., Kankakee, Ill.) to form component two. The side of application of fibrin tissue adhesive was randomly assigned before surgery. When the patient's symptoms were more severe on one side or when, during the procedure, one side was noted to have more severe disease, that side was selected for application of the fibrin. Each component was placed in a warming bath at 37 ° C. Before application, 1 ml of each component was placed in separate 3-ml syringes. The syringes were attached to a Duoflo (Hemaedics Inc., Pacific Palisades, Calif.) dispenser with a 20-gauge spinal needle (Fig. 1). This dispenser prevented the components from mixing before reaching the needle. At the conclusion of the operation on the selected side, the raw surfaces of the sinuses, sinus ostia, and middle turbinate were coated with a thin layer of fibrin tissue adhesive. Because fibrin adhesive has the viscosity of a liquid gel, it sticks to the surface and coats the operative wound broadly and easily. A total of 1 or 2 ml of each component was used for each patient. Care was taken to avoid sealing of any ostia. Bacitracin ointment was placed in the nasal cavity. At the conclusion of the operation on the contralateral side, Gelfoam packing coated with bacitracin ointment was placed. All patients were seen 2 days after operation for removal of the packing. Patients were examined at weekly intervals for 3 weeks and then at monthly intervals. At these visits, the patients were questioned regarding their comfort level on each side, sensation of airway patency, and whether bleeding had occurred. Three surgeons (S. M. S., L. L. G., and E. E. R.) evaluated all patients and noted the comparative degree of crust formation on each side, patency of the ostia, mucosal healing, scar formation, and any recurrence of disease by endoscopic examination or by viewing the videotapes of the examination. All patients were given cephalexin, 500 mg four times a day, orally for 3 weeks after surgery. Other antibiotics were chosen on the basis of the results of sensitivity testing of the operative cultures. RESULTS
The fibrinogen was precipitated during the operation within 30 minutes of the phlebotomy in each
240
GLEICH et al.
Otolaryngology Head and Neck Surgery February 1995
Fig. I. Fibrin dispenser with attached syringes for two components. Components do not mix until reaching the needle.
patient. A dry surgical field was obtained on application of the fibrin tissue adhesive in all patients, and packing was not required. No patient had bleeding during the postoperative period. All patients reported that the fibrin-treated side felt more patent, especially during the first month after operation, and the avoidance of bilateral intranasal packing resulted in considerable improvement in patient satisfaction. The sinus cavities were examined at weekly intervals, and any crusts were removed. The fibrin-treated side had less crusting, and when crusts were present, removal was easier (Fig. 2). A thin, clear film was visible at the sites of application of the fibrin for the first 2 weeks after the operation and provided a coating to the sinuses and ostia. Healing appeared to be faster, with minimal scar formation on the fibrin-treated side. When the middle turbinate was intact, application of fibrin decreased formation of adhesions and stabilized the turbinate superiorly, diminishing its tendency toward lateralization. No complications occurred on either side in any of the patients. None of the patients had extensive scarring, recurrence of disease, or bleeding. DISCUSSION
This study demonstrated that autologous fibrin tissue adhesive is beneficial in endoscopic sinus surgery. The fibrin resulted in increased patient satisfaction, especially with regard to eliminating the need for packing. By treating only one side in each patient, comparisons were possible with a control side. In patients in whom the disease was asymmet-
Fig. 2. Patient 3 weeks after endoscopic sinus surgery with the application of fibrin tissue adhesive to the left side. A, Left side demonstrates decreased crusting with open sinuses. B, Right side shows persistent crusting.
ric, the more diseased side was always treated. Postoperative evaluation uniformly demonstrated a tendency toward fewer adhesions, easier removal of crust from the fibrin-adhesive side, and more rapid mucosal healing. The application of autologous fibrin tissue adhesive during endoscopic sinus surgery resulted in a high degree of patient satisfaction and facilitated healing of the treated sinuses without added m o r -
Otolaryngology Head and Neck Surgew
GLEICH et al.
Volume 1t2 Number2
bidity. Autologous fibrin tissue adhesive is beneficial in endoscopic sinus surgery and has become our standard for postoperative treatment. REFERENCES
1. Matras H. Fibrin seal: the state of the art. J Oral Maxillofac Surg 1985;43:605-11. 2. Staindl O. Tissue adhesion with highly concentrated human fibrinogen in otolaryngology. Ann Otol Rhinol Laryngol 1979; 88:413-8.
3. Valleiz D, Descottes B. Pregluing of circular instrumental anastomoses. Surg Gynecol Obstet 1990;170:161-2. 4. Dulchavsky SA, Geller ER, Maurer J, Kennedy PR, Tortora GT, Maitra SR. Autologous fibrin gel: bactericidal properties in contaminated hepatic injuries, J Trauma 1991;31:991-5. 5. Siedentop KH, Harris DM, Ham K, Sanchez B. Extended experimental and preliminary surgical findings with autologous fibrin tissue adhesive made from a patient's own blood. Laryngoscope 1986;96:1062-4. 6. Siedentop KH, Harris DM, Sanchez B. Autologus fibrin tissue adhesive. Laryngoscope 1985;95:1074-6.
1-800-55-MOSBY
This number links you to the full text of literally every article ever published in Mosby journals. MOSBY Document Express TM, a rapid response information retrieval service, provides quick turnaround, 24-hour availability, and speedy delivery methods. For inquiries and pricing information, call our toll-free, 24-hour order line: 1-800-55-MOSBY; outside the U.S.: 415-259-5046; fax: 415-259-4019; E-mail: [email protected]. MOSBY Document Express
TM
241
is offered in cooperation with Dynamic Information Corp.
Endoscopic telescopes used in sinus surgery have increased surgical precision, but complications still occur and are often related to bleeding or to scar formation. Application of a substance that is hemostatic and bacteriostatic and that aids the healing of raw surfaces created during the operation should decrease the complication rate. From the Department of Otolaryngology-Head and Neck Surgery and the Eleanor Naylor Dana Laser Research Laboratory, Lahey Clinic. Supported in part by a grant from the Eleanor Naylor Dana Charitable Trust, New York, N.Y. Presented at the Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Minneapolis, Minn., Oct. 2-6, 1993. *Dr. Gleich's current address is New York Eye and Ear Infirmary, New York Medical College, 310 East 14th St., New York, NY 10003. Received for publication Dec. 16, 1993; revisionreceived July 22, 1994; accepted July 29, 1994. Reprint requests: Stanley M. Shapshay, MD, Department of Otolaryngology-Head and Neck Surgery, New England Medical Center Hospitals, #850, 750 Washington Stl, Boston, MA 02111. Copyright © 1995 by the American Academy of OtolaryngologyHead and Neck Surgery Foundation, Inc. 0194-5998/95/$3.00 + 0 23/1/59517 238
Fibrin tissue adhesive manufactured from pooled h u m a n blood has been used successfully in Europe with multiple applications, including neural anastomosis, hemostasis in soft-tissue defects, fixation of skin grafts, sealing of bone and dura, and gastrointestinal anastomosis. 1-3 Fibrin tissue adhesive has two components. The first component is obtained from human plasma and has concentrated h u m a n fibrinogen and factor XIII. The second component contains commercially available thrombin. The mixing of the two components in the presence of calcium causes the conversion of fibrinogen to fibrin. This product is adhesive, is hemostatic, is a p r o m o t e r of wound healing, 1 and is bacteriostatic. 4 Natural fibrinolysis results in complete absorption of sealant. The potential dangers of viral infection and immune reaction have led to the development of methods of preparation of fibrin tissue adhesive from the patient's own blood. 5,6 In endoscopic sinus surgery, fibrin tissue adhesive may improve mucosal healing with a resultant decrease in scar formation and adhesions. Additionally, when used during operation, increased hemostatic control permits better visualization. The hemostatic properties of the adhesive can also
Otolaryngology Head and Neck Surgery Volume 112
GLEICH et al.
Number 2
decrease the need for packing, reducing the risk of infection and improving mucosal healing. Autologous fibrin tissue adhesive was applied to one side in patients undergoing bilateral endoscopic sinus surgery, and the other side was used as a control. Comparisons were made during the operation and during the postoperative period with video recording and photographic documentation to assess the efficacy of fibrin tissue adhesive in endoscopic sinus surgery. METHODS AND MATERIAL
Twelve patients with chronic sinus disease resistant to medical therapy were enrolled in the study from Oct. 1, 1992, to Dec. 31, 1992. The seven men and five women ranged in age from 19 to 58 years (average, 44.6 years). Ten of the patients had prior endonasal surgery, including endoscopic sinus surgery (four patients), intranasal ethmoidectomy (two patients), nasal polypectomy (five patients), septoplasty (three patients), and turbinectomy (one patient). Six of the patients had asthma, and three of these patients had triad asthma. Five of the patients had a history of smoking, and one patient had a history of bleeding after an earlier sinus procedure. Endonasal examination revealed either extensive polyps or scarring in all patients. Computed tomography was obtained in all patients and demonstrated pansinusitis in nine patients, bilateral extensive maxillary and ethmoid disease in two patients, and bilateral frontal and ethmoid disease in one patient. Informed consent for unilateral application of fibrin tissue adhesive was obtained from each patient, and the procedures were performed at the Lahey Clinic with the approval of the institutional review board. The surgical procedures were performed by one surgeon (S. M. S.), and results of video-recorded follow-up visits were evaluated by two additional surgeons (E. E. R. an L. L. G.). General anesthesia was induced, and after intubation, 72 ml of blood was obtained for autologous fibrinogen precipitation. Lidocaine, 1% with epinephrine 1:100,000, was injected intranasaIly for vasoconstriction, and endoscopic sinus surgery was performed. The precipitation of autologous fibrinogen was performed as described by Siedentop et a l / T o eight tubes, each containing 1 ml of 10% sodium citrate, 9 ml of the patient's blood was added. The tubes were centrifuged at 3200 rpm for 10 minutes, and the plasma was separated. To each tube of plasma, 1.3 ml of saturated ammonium sulfate was added. The eight tubes were centrifuged at 3200 rpm for
239
3 minutes. The precipitates were collected in one tube to which 1 ml of 40 mmol/L calcium chloride was added. This formed component one. A 3-ml solution was made by adding 0.5 ml of a 20 mg/ml solution of epsilon aminocaproic acid to 2.5 ml of sterile water; 1 ml of this solution was added to 1000 NIH units of thrombin powder (Armour Pharmaceutical Co., Kankakee, Ill.) to form component two. The side of application of fibrin tissue adhesive was randomly assigned before surgery. When the patient's symptoms were more severe on one side or when, during the procedure, one side was noted to have more severe disease, that side was selected for application of the fibrin. Each component was placed in a warming bath at 37 ° C. Before application, 1 ml of each component was placed in separate 3-ml syringes. The syringes were attached to a Duoflo (Hemaedics Inc., Pacific Palisades, Calif.) dispenser with a 20-gauge spinal needle (Fig. 1). This dispenser prevented the components from mixing before reaching the needle. At the conclusion of the operation on the selected side, the raw surfaces of the sinuses, sinus ostia, and middle turbinate were coated with a thin layer of fibrin tissue adhesive. Because fibrin adhesive has the viscosity of a liquid gel, it sticks to the surface and coats the operative wound broadly and easily. A total of 1 or 2 ml of each component was used for each patient. Care was taken to avoid sealing of any ostia. Bacitracin ointment was placed in the nasal cavity. At the conclusion of the operation on the contralateral side, Gelfoam packing coated with bacitracin ointment was placed. All patients were seen 2 days after operation for removal of the packing. Patients were examined at weekly intervals for 3 weeks and then at monthly intervals. At these visits, the patients were questioned regarding their comfort level on each side, sensation of airway patency, and whether bleeding had occurred. Three surgeons (S. M. S., L. L. G., and E. E. R.) evaluated all patients and noted the comparative degree of crust formation on each side, patency of the ostia, mucosal healing, scar formation, and any recurrence of disease by endoscopic examination or by viewing the videotapes of the examination. All patients were given cephalexin, 500 mg four times a day, orally for 3 weeks after surgery. Other antibiotics were chosen on the basis of the results of sensitivity testing of the operative cultures. RESULTS
The fibrinogen was precipitated during the operation within 30 minutes of the phlebotomy in each
240
GLEICH et al.
Otolaryngology Head and Neck Surgery February 1995
Fig. I. Fibrin dispenser with attached syringes for two components. Components do not mix until reaching the needle.
patient. A dry surgical field was obtained on application of the fibrin tissue adhesive in all patients, and packing was not required. No patient had bleeding during the postoperative period. All patients reported that the fibrin-treated side felt more patent, especially during the first month after operation, and the avoidance of bilateral intranasal packing resulted in considerable improvement in patient satisfaction. The sinus cavities were examined at weekly intervals, and any crusts were removed. The fibrin-treated side had less crusting, and when crusts were present, removal was easier (Fig. 2). A thin, clear film was visible at the sites of application of the fibrin for the first 2 weeks after the operation and provided a coating to the sinuses and ostia. Healing appeared to be faster, with minimal scar formation on the fibrin-treated side. When the middle turbinate was intact, application of fibrin decreased formation of adhesions and stabilized the turbinate superiorly, diminishing its tendency toward lateralization. No complications occurred on either side in any of the patients. None of the patients had extensive scarring, recurrence of disease, or bleeding. DISCUSSION
This study demonstrated that autologous fibrin tissue adhesive is beneficial in endoscopic sinus surgery. The fibrin resulted in increased patient satisfaction, especially with regard to eliminating the need for packing. By treating only one side in each patient, comparisons were possible with a control side. In patients in whom the disease was asymmet-
Fig. 2. Patient 3 weeks after endoscopic sinus surgery with the application of fibrin tissue adhesive to the left side. A, Left side demonstrates decreased crusting with open sinuses. B, Right side shows persistent crusting.
ric, the more diseased side was always treated. Postoperative evaluation uniformly demonstrated a tendency toward fewer adhesions, easier removal of crust from the fibrin-adhesive side, and more rapid mucosal healing. The application of autologous fibrin tissue adhesive during endoscopic sinus surgery resulted in a high degree of patient satisfaction and facilitated healing of the treated sinuses without added m o r -
Otolaryngology Head and Neck Surgew
GLEICH et al.
Volume 1t2 Number2
bidity. Autologous fibrin tissue adhesive is beneficial in endoscopic sinus surgery and has become our standard for postoperative treatment. REFERENCES
1. Matras H. Fibrin seal: the state of the art. J Oral Maxillofac Surg 1985;43:605-11. 2. Staindl O. Tissue adhesion with highly concentrated human fibrinogen in otolaryngology. Ann Otol Rhinol Laryngol 1979; 88:413-8.
3. Valleiz D, Descottes B. Pregluing of circular instrumental anastomoses. Surg Gynecol Obstet 1990;170:161-2. 4. Dulchavsky SA, Geller ER, Maurer J, Kennedy PR, Tortora GT, Maitra SR. Autologous fibrin gel: bactericidal properties in contaminated hepatic injuries, J Trauma 1991;31:991-5. 5. Siedentop KH, Harris DM, Ham K, Sanchez B. Extended experimental and preliminary surgical findings with autologous fibrin tissue adhesive made from a patient's own blood. Laryngoscope 1986;96:1062-4. 6. Siedentop KH, Harris DM, Sanchez B. Autologus fibrin tissue adhesive. Laryngoscope 1985;95:1074-6.
1-800-55-MOSBY
This number links you to the full text of literally every article ever published in Mosby journals. MOSBY Document Express TM, a rapid response information retrieval service, provides quick turnaround, 24-hour availability, and speedy delivery methods. For inquiries and pricing information, call our toll-free, 24-hour order line: 1-800-55-MOSBY; outside the U.S.: 415-259-5046; fax: 415-259-4019; E-mail: [email protected]. MOSBY Document Express
TM
241
is offered in cooperation with Dynamic Information Corp.