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Suture support: Is it advantageous?
The American Journal of Surgery 182 (2001) 15S–20S
Suture support: Is it advantageous? Henrik K. Kjaergard, M.D. Department of Cardiothoracic Surgery, Gentofte University Hospital, Niels Andersens Vej 65, 2900 Hellerup, Denmark
Abstract Sutures have been used to facilitate and enhance wound closure and healing throughout the course of medical history. Suturing is still the most common method of wound closure, but in some surgical situations suture support can improve clinical outcomes. Sutures provide mechanical support to a wound and help create the optimal environment for wound healing. However, suturing can give rise to such complications as bleeding from suture holes and air and fluid leakage. In the last 25 years, fibrin sealants have been used increasingly in the clinical setting to assist in the sealing of surgical wounds and to give additional mechanical support to a range of wounds during the early phases of wound healing. The use of fibrin sealants in addition to sutures has a direct effect on hemostasis and blood loss. Fibrin sealants also reduce the volume of fluid drained and air leakage postoperatively in head, neck, and thoracic surgery, in some cases resulting in a reduced length of hospital stay. The use of fibrin sealant as suture support can also reduce the number of sutures and the length of operations for intricate or complex procedures. The aim of this article is to provide an overview of how fibrin sealants acting as an adjunct to sutures affect surgical outcomes. © 2001 Excerpta Medica, Inc. All rights reserved.
The use of sutures to aid wound closure dates back to 3500 BC, when it was first alluded to in an Egyptian scroll [1]. Today, suturing is still the most common method of wound closure, and recent advances in suture materials now allow surgeons to select the most appropriate suture for the particular wound or surgical intervention. Ideally, the chosen suture should provide mechanical support to a wound and create the optimal environment for wound healing until the tissue is sufficiently healed to withstand normal physical stress. In choosing an appropriate suture type for wound closure and healing, surgeons need to consider the strength of the suture, the type of tissue being held, and the absorbability of the sutures, because healing rates vary between tissues [2]. It is well known that tissue healing rates vary depending on the tissue; for example, skin heals much more quickly than fascia [2]. It has also been shown that skin wounds regain 85% of their original strength by day 15 [2]. However, many sutures start to lose their strength from day 3 to day 9, contributing little or no mechanical support from day 9 [3]. Furthermore, it has been reported that sutures fail to provide significant mechanical support for abdominal wounds between postoperative days 15 and 28 [4,5]. Complications associated with suturing in a variety of surgical interventions include mainly bleeding from sutures
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and also air and fluid leakage. Bleeding from suture holes is a frequent occurrence in cardiothoracic and vascular surgery and may impact on postoperative morbidity and mortality [6]. The spray application of fibrin sealant may reduce perioperative hemorrhage during cardiac operations [6]. Resection of some parenchymal tissue may also lead to prolonged bleeding, and fibrin sealant has been used as an effective hemostat in diffuse bleeding organs where suturing is difficult or impossible [7]. Occasionally, fluid leakage may be a problem in gastrointestinal anastomosis (eg, esophageal and colorectal anastomosis), and in these difficult cases the application of fibrin sealants can reduce both fluid leakage and the potential risk of infection resulting from leakage. Suturing is the method of choice for wound closure. Inflammatory reactions and occasionally infections may occur as a result of sutures. However, the inflammation associated with sutures is not usually a problem for either the patient or the surgeon. A review of the literature indicates that reduced-suture fibrin sealant anastomosis and sutureless fibrin sealant anastomosis may be performed with less inflammation and necrosis compared with conventional suturing techniques [8]. Although many technologic advances have been made in surgical procedures and surgical materials (such as suture materials), reducing the incidence of complications is still of importance to surgeons. For many years, surgeons have been using fibrin sealant in conjunction with sutures (or
0002-9610/01/$ – see front matter © 2001 Excerpta Medica, Inc. All rights reserved. PII: S 0 0 0 2 - 9 6 1 0 ( 0 1 ) 0 0 9 1 0 - X
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H.K. Kjaergard / The American Journal of Surgery 182 (2001) 15S–20S
Fig. 1. Perioperative blood loss from the mediastinum is reduced after suture support [6]. *P ⬍0.05, unpaired Student’s t test.
alone) to improve the integrity of wound closure in terms of reduced hemorrhage from the suture line and suture holes [9 –13]. Indeed, in some surgical procedures a reduction in the number of stitches required to maintain wound closure is observed after the use of fibrin sealants. Some delicate tissues, such as lung parenchymal tissue, can also be closed with fibrin sealant. In addition, fibrin sealants do not initiate/ exacerbate an undue inflammatory response. The aim of this review is to compare the clinical outcome of the use of fibrin sealants as an adjunct to sutures in surgical practice to aid wound closure and healing.
Suture support To date, suture support has been described widely in the literature with varying definitions. Here we use suture support to describe the use of fibrin sealant as an adjunct to sutures after surgical intervention, resulting in additional mechanical support, prevention/reduction of needle hole and suture line bleeding, and an aid to healing.
Fibrin sealant in clinical practice Fibrin sealants were developed some 25 years ago as biologic tissue adhesives. The utility of fibrin sealants in cardiovascular surgery was recognized as early as the late 1970s [14]. Since then, fibrin sealants have been used in a wide range of surgical procedures, including cardiothoracic, head and neck surgery, thyroid surgery, neurosurgery, and vascular surgery to provide suture support. Hemostasis Postoperative blood loss after cardiac surgery requires re-operation in 4.4% of patients [15]. Fibrin sealants have
been used successfully in conjunction with sutures in cardiothoracic surgery to produce hemostasis. Indeed, fibrin sealant to support suture has been reported to be 94% or more effective at reducing blood loss after cardiovascular and thoracic surgery [16,17]. Control of blood loss from such sites as the mediastinum, specific sites at coronary artery bypass graft anastomoses, and long suture lines was achieved with the use of fibrin sealant [16]. This observation supports the earlier finding by Spotnitz et al [6] that perioperative hemorrhage from the mediastinum was significantly reduced by suture support. Blood loss in procedures using fibrin sealant as suture support at 12 and 24 hours was 461 mL and 714 mL, respectively, compared with 731 mL and 1,016 mL, respectively, for the control group (Fig. 1) [6]. The volume of blood lost during surgery is dependent on a number of factors, including use of intraoperative heparin, complexity of the surgery being performed, and the time taken to induce hemostasis. The use of fibrin sealants in surgery has been shown to significantly reduce the time to hemostasis with a beneficial effect on blood loss. In a randomized study in 17 patients undergoing surgery for carotid endarterectomy, suture support reduced suture line bleeding by 130 mL compared with the blood loss from patients who did not receive fibrin sealant [18]. In addition, the time to hemostasis in the suture support group was significantly lower at 5.5 minutes compared with 19 minutes in the control group (P ⱕ0.005; Table 1). Furthermore, 100% of patients in the control group required oxidized cellulose gauze to aid hemostasis compared with only 13% in the suture support group [18]. The observation that hemostasis was achieved more quickly in patients after suture support has been confirmed in another randomized study of peripheral vascular surgery. Hemostasis was achieved in 0.5 minutes in the suture support group compared with 4 minutes in the control group (P ⬍0.014; Table 1) [19]. Moreover, immediate hemostasis
H.K. Kjaergard / The American Journal of Surgery 182 (2001) 15S–20S Table 1 Time to hemostasis (mean range) after carotid endarterectomy and peripheral vascular surgery with or without fibrin sealant suture support Procedure
Study
Control (mins)
Fibrin sealant (mins)
P value
Carotid endarterectomy Peripheral vascular surgery
Milne et al, 1995 [18] Milne et al, 1996 [19]
19 (10–47)
5.5 (4–31)
0.005
4 (0–21)
0.5 (0–11)
0.014
was achieved on release of the clamps in 62% of patients in the suture support group compared with 22% in the control group [19]. These observations indicate that suture support can also be used as successfully in peripheral vascular surgery as it has been in cardiovascular surgery. Fibrin sealants have also been used successfully for hemostasis in neurosurgery for such procedures as arteriovenous malformation, middle cerebral artery aneurysm, orbital tumor, oligodendroglioma, meningioma, and ophthalmic aneurysm [20]. Indeed, suture support in patients undergoing surgery for intracranial artery aneurysm (n ⫽ 11) has been shown to be effective with no recurrent bleeding of the aneurysm in 100% of patients during the 25month follow-up period [20]. In most cases, local hemostasis was achieved within 1 minute of application of fibrin sealant [20]. The use of electrocautery, particularly in neurosurgery, is currently under review. In such sensitive tissues as the brain, where tissue damage can cause irreparable damage, electrocautery is used with caution. In these situations the use of fibrin sealant and sutures can reduce the need for this destructive technique. Blood loss associated with head and neck surgery is of concern to surgeons, especially as the rest (minimal movement of the head and neck) that is necessary to facilitate wound healing may not be taken for granted. Conservative or radical neck surgery performed for resection of malignant neoplasms of the oral cavity can leave large areas of raw tissue that can exude blood. The unavoidable rotation and flexion– extension movement of the neck may, in some cases, cause renewed bleeding. Fibrin sealant used in conjunction with suction drainage not only produced hemostasis, but also significantly reduced the volume of wound secretion after either radical or conservative neck surgery, during the first 2 postoperative days (P ⱕ0.05) [21]. Although the volume of wound secretion was greater after radical surgery compared with conservative surgery, the difference in secretory volume after the use of commercial fibrin sealant was not significantly different [21]. Fluid and air leakage Fibrin sealants have also been used in other surgical procedures, such as head and neck surgery and thoracic
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surgery, with success. In thyroid surgery, suture support significantly reduced the volume of fluid drained during the first postoperative night by approximately 50% (18 mL compared with 39 mL for suture alone; P ⱕ0.0001) [22]. Furthermore, the mean time to drain removal was 1.6 days in the fibrin sealant group and 2.2 days in the control group. This meant that patients in the fibrin sealant group were discharged from hospital after a mean of 2.8 days, with most patients leaving the day after drain removal. Overall, patients in the suture support group were discharged from hospital 0.9 days earlier than the control group. In this series of 30 patients, this translated to a saving of 27 bed days or the equivalent of approximately seven additional thyroidectomies. The cost difference between the two arms of the study was approximately $260 per patient in favor of fibrin sealant treatment or $7,900 per study group. Cost estimates were current for 1991 [22]. In 1990, Matthew et al [16] reported that the use of fibrin sealant in various thoracic and cardiovascular procedures was 100% (14 of 14 patients) successful in reducing fluid loss. Cerebrospinal fluid leakage is associated with complex neurosurgical procedures. Fibrin sealant has been used with success to prevent or stem cerebrospinal fluid leakage from pituitary tumor, metastatic tumors, oligodendroglioma, and cerebrospinal fluid rhinorrhea [20]. However, some cerebrospinal leakage was observed after the use of fibrin sealant in a few neurosurgical procedures [20]. In pulmonary resections, fibrin sealant has been shown to reduce blood loss from cut lung surfaces and bronchial anastomoses and to reduce air leakage with a success rate of 88% [16]. Fibrin sealant, in addition to reducing the incidence of air leakage, also reduced the frequency of postoperative air leakage with an estimated risk reduction of 41%. Furthermore, an improvement rate of 81% was obtained in the airway tolerance–pressure test in patients after suture support [23]. Mouritzen [23] also reported a significant reduction in length of hospital stay and a reduction in the number of patients in the fibrin sealant group with complications compared with controls. There was no estimate of cost saving reported for this study. Surgical time Surgical procedures that are intricate and/or complex, for example, vascular/microvascular surgery for digital replantation, can be time consuming. However, in the case of digital replantation, it is important to re-establish blood flow as soon as possible to reduce the ischemia induced by amputation. Techniques that shorten the operative time contribute to the success of digit replantation. Fibrin sealant has been used successfully as suture support in microvascular anastomoses in digit replantation surgery. The survival rate of digit replantation surgery after suture support (89%) was comparable with that reported for conventional microvascular surgery [24]. In addition, fibrin sealant–assisted mi-
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H.K. Kjaergard / The American Journal of Surgery 182 (2001) 15S–20S
Fig. 2. Hydrostatic leak pressure (cm H2O) for skin tubes as a function of time (days) after suturing alone and with fibrin sealant treatment [32]. *0.05 ⬍ P ⬍ 0.10.
crovascular anastomosis did reduce the operative time by approximately 1.3 hours. This was a direct consequence of the reduced number of microsutures required at each anastomosis [24]. The development of safe, effective procedures that reduce operating times compared with conventional techniques has a positive impact on direct health-care costs. Adverse events Fibrin sealant is a product that uses blood-derived fibrinogen as one of its main constituents. The potential risk of transmission of blood-borne infection, such as hepatitis and human immunodeficiency virus, by fibrin sealants has been of concern to surgeons. However, to date there have been no documented reports of transmission of hepatitis or HIV infection from the use of fibrin sealant [25]. Indeed, at 6 months there was no serologic evidence of hepatitis A, B, or C, and no patients developed abnormal liver function tests during follow-up visits [18]. There is a rare but elevated risk of hypersensitivity reactions at re-exposure to aprotinin and immunization and bleeding from re-exposure to bovine thrombin. Most manufacturers have therefore switched over to human thrombin [26,27]. With appropriate precautions, re-exposure to aprotinin in patients, particularly those with a high risk of bleeding, is reported to be justified, and the benefits of aprotinin treatment are thought to outweigh the relative risk of a serious allergic reaction [28]. Animal studies The mechanical support offered by sutures with and without suture support with fibrin sealant cannot be determined in human subjects for obvious ethical reasons. Consequently, these studies are performed in animal models,
because it is important to determine the bursting pressure of sutures with and without suture support. Suture support Gastrointestinal anastomoses may occasionally leak, and colonic, low rectal, and esophageal anastomoses are more susceptible to leakage than other anastomoses despite good surgical technique. The option to use fibrin sealant gives the surgeon additional suture support and can reduce the potential risk of leakage in successful surgery. The leakage of colonic contents into the peritoneum can lead to peritonitis or sepsis with a fatal outcome. Fibrin sealant has been used experimentally to assess the suitability of suture support in colon anastomoses in an experimental rat model. Bursting pressures of 94 and 131 mm Hg were obtained for colonic anastomoses closed with suture support compared with 68 and 92 mm Hg for colonic anastomoses closed with sutures alone (1 mm Hg ⫽ 1.36 cm H2O) [29,30]. This additional firmness lasted for the duration of the 3-week observation period [29]. These findings are further supported by results in porcine stapled small bowel where suture support resulted in anastomoses that did not leak and showed only a mild inflammatory response compared with sutures alone [31]. Similar observations have been reported for skin wounds closed with sutures and suture support. Suture support resulted in watertight sutures immediately after surgery and increased the hydrostatic pressure resistance of skin sutures by 17.2 cm H2O (Fig. 2) [32]. At days 3 and 6, skin sutures supported with fibrin sealant were able to withstand increased hydrostatic pressures of 23.1 and 16.8 cm H2O, respectively (Fig. 2; 0.05 ⬍ P ⬍ 0.10) [32]. Similar results were reported for bladder sutures supported with fibrin sealant. These results suggest that the watertightness of
H.K. Kjaergard / The American Journal of Surgery 182 (2001) 15S–20S
conventional suturing can be improved with suture support. This could have clinical implications in urology, where a watertight suture may prevent urine extravasation in the wound and reduce or eliminate the associated complication of postoperative infection and the need for urinary diversion. As observed in the clinical setting, suture support has been shown to produce hemostasis in experimental models. Fibrin sealant has been reported to minimize blood loss after microvascular repair in hypertensive rats with no leakage or loss of patency of the anastomoses [33]. More recently, suture support was shown to significantly (P ⱕ0.05) reduce hemorrhage from carotid vascular grafts in a porcine model. The mean blood loss was 9.2 mL in the suture support group compared with 178.8 mL in the control group [34]. These results suggest that suture support would prevent leakage of blood after vascular and/or microvascular repair surgery, even in cases of high blood pressure. Suture support has also been used successfully in experimental delayed vasovasostomy in a rat model with results comparable to conventional suturing. However, after suture support only three sutures instead of the usual six sutures were required to produce similar anatomical results in vasal anastomoses. Furthermore, the mean operative time with fibrin sealant–assisted vasovasostomy was significantly shorter (P ⱕ0.001) than conventional suturing and was technically less demanding [35].
Conclusion The use of suture support in a broad spectrum of surgical procedures provides several advantages to the patient. The benefits of suture support include hemostasis, resulting in reduced blood loss from needle hole and suture line wounds, thus reducing the need for blood transfusion after such prolonged and complex surgical procedures as cardiovascular surgery; and a reduction in the drain volume and air leakage during thoracic and cardiac surgery, thereby shortening the time required for a chest drain, resulting in fewer days of discomfort for patients and in some cases a significant shortening of hospital stay. Suture support may also improve the success rate of some surgical procedures by reducing the complexity of the procedures, as has been observed in digit replantation surgery. Furthermore, suture support is safe and well tolerated by patients with no indication of viral infection from the fibrin sealant and few adverse reactions.
References [1] Snyder CC. On the history of the suture. Plast Reconstr Surg 1976; 58:401. [2] Douglas DM. The healing of aponeurotic incisions. Br J Surg 1952; 40:79 – 84.
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[3] Adamson RJ, Enquist IF. The relative importance of sutures to the strength of healing wounds under normal and abnormal conditions. Surg Gynecol Obstet 1963;117:369 – 401. [4] Nilsson T. The relative importance of Vicryl and Prolene sutures to the strength of healing abdominal wounds. Acta Chir Scand 1981; 147:503–7. [5] Nilsson T. Abdominal wound repair. An experimental study of the wound healing mechanism in the rabbit. Dan Med Bull 1993;30:394 – 407. [6] Spotnitz WD, Dalton MS, Baker JW, Nolan SP. Reduction of perioperative haemorrhage by anterior mediastinal spray application of fibrin glue during cardiac operations. Ann Thorac Surg 1987;4:529 – 31. [7] Rousou JA, Engelman RM, Breyer RH. Fibrin glue: an effective hemostatic agent for nonsuturable intraoperative bleeding. Ann Thorac Surg 1984;38:409 –10. [8] Spotnitz WD, Falstrom JK, Rodenheaver GT. The role of sutures and fibrin sealant in wound healing. Surg Clin North Am 1997;77:651– 69. [9] Ko¨vekar G. Clinical application of fibrin glue in cardiovascular surgery. Thorac Cardiovasc Surg 1982;30:228 –9. [10] Ko¨vekar G, de Vivie ER, Hellberg KD. Clinical experience with fibrin glue in cardiac surgery. Thorac Cardiovasc Surg 1987;19: 287–9. [11] Mandel MA. Closure of blepharoplasty incisions with autologous fibrin glue. Arch Ophthalmol 1990;108:842– 4. [12] Meisner H, Struck E, Schmidt-Habelmann P, Sebening F. Fibrin seal application: clinical experience. Thorac Cardiovasc Surg 1982;30: 232–3. [13] Reiter D. Methods and material for wound closure. Otolaryngol Clin North Am 1995;28:1069 – 80. [14] Spangler HP. Blutgerinnungsfaktor XIII (experimentelle untersuchungen und klinische erfahrungen). Wein Klin Wochenschr 1976; 88(suppl 49):3–18. [15] Sellman M, Intonti MA, Ivert T. Reoperations for bleeding after coronary artery bypass procedures during 25 years. Eur J Cardiothorac Surg 1997;11:521–7. [16] Matthew TL, Spotnitz WD, Irving L, et al. Four years’ experience with fibrin sealant in thoracic and cardiovascular surgery. Ann Thorac Surg 1990;50:40 – 4. [17] Borst HG, Haverich A, Walterbush G, Maatz W. Fibrin adhesive: an important hemostatic adjunct in cardiovascular operations. J Thorac Cardiovasc Surg 1982;84:548 –53. [18] Milne AA, Murphy WG, Reading SJ, Ruckley CV. Fibrin sealant reduces suture line bleeding during carotid endarterectomy: a randomised trial. Eur J Endovasc Surg 1995;10:91– 4. [19] Milne AA, Murphy WG, Reading SJ, Ruckley CV. A randomised trial of fibrin sealant in peripheral vascular surgery. Vox Sang 1996; 70:210 –2. [20] Lee K-C, Park S-K, Lee K-S. Neurosurgical application of fibrin adhesive. Yonsei Med J 1991;32:53–7. [21] Stoll P. Prevention of bleeding after neck dissection. Biomed Prog 1996;9:45– 8. [22] Matthews TW, Briant TD. The use of fibrin tissue glue in thyroid surgery: resource utilisation implications. J Otolaryngol 1991;20: 276 – 8. [23] Mouritzen C. Fibrin adhesives and pulmonary resections and decortications: sealing bronchial and alveolar leakages. Biomed Prog 1991; 4:61–3. [24] Isogai N, Cooley BG, Kamiishi H. Clinical outcome of digital replantation using fibrin glue-assisted microvascular anastomosis technique. J Hand Surg 1996;21:573–5. [25] Spotnitz WD. Fibrin sealant in the United States: clinical use at the University of Virginia. Thromb Haemost 1995;47:482–5. [26] Scheule AM, Beierlein MS, Wendel HP, et al. Fibrin sealant, aprotinin, and immune response in children undergoing operations for congenital heart disease. J Thorac Cardiovasc Surg 1998;115:883–9.
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[27] Beierlein W, Scheule AM, Antoniadis G, et al. An immediate, allergic skin reaction to aprotinin after reexposure to fibrin sealant. Transfusion 2000;40:302–5. [28] Dietrich W. Incidence of hypersensitivity reactions. Ann Thorac Surg 1998;65:S60 – 4. [29] Elfeldt R, Leuze D, Thiede A, Seifert J. Experimental animal studies of the stability of colon anastomoses after supplementary fibrin glue sealing. Z Exp Chir Transplant Kunstliche Organe 1990;23:47– 50. [30] Byrne DJ, Hardy J, Wood RA, et al. Adverse influence of fibrin sealant on the healing of high-risk sutured colonic anastomoses. J R Coll Surg Edinb 1992;37:394 – 8. [31] Zilling TL, Jansson O, Walther BS, Ottosson A. Sutureless small
[32] [33]
[34]
[35]
bowel anastomoses: experimental study in pigs. Eur J Surg 1999;165: 61– 8. Oosterlinck W, Cheng H, Hoebeke P, Verbeeck R. Watertight sutures with fibrin glue: an experimental study. Eur Urol 1993;23:481– 4. Isogai N, Fukunishi K, Kamiishi H. Use of fibrin to minimise bleeding of microvascular repairs in hypertensive rats. Microsurgery 1992; 13:321– 4. Dickneite G, Metzner H, Nicolay U. Prevention of suture hole bleeding using fibrin sealant— benefits of factor XIII. J Surg Res 2000;93: 201–5. Vankemmel O, Rigot JM, Burnouf T, Mazeman E. Delayed vasal reanastomosis in rats: comparison of a microsurgical technique and a fibrin-glued procedure. Br J Urol 1996;78:271– 4.
Suture support: Is it advantageous? Henrik K. Kjaergard, M.D. Department of Cardiothoracic Surgery, Gentofte University Hospital, Niels Andersens Vej 65, 2900 Hellerup, Denmark
Abstract Sutures have been used to facilitate and enhance wound closure and healing throughout the course of medical history. Suturing is still the most common method of wound closure, but in some surgical situations suture support can improve clinical outcomes. Sutures provide mechanical support to a wound and help create the optimal environment for wound healing. However, suturing can give rise to such complications as bleeding from suture holes and air and fluid leakage. In the last 25 years, fibrin sealants have been used increasingly in the clinical setting to assist in the sealing of surgical wounds and to give additional mechanical support to a range of wounds during the early phases of wound healing. The use of fibrin sealants in addition to sutures has a direct effect on hemostasis and blood loss. Fibrin sealants also reduce the volume of fluid drained and air leakage postoperatively in head, neck, and thoracic surgery, in some cases resulting in a reduced length of hospital stay. The use of fibrin sealant as suture support can also reduce the number of sutures and the length of operations for intricate or complex procedures. The aim of this article is to provide an overview of how fibrin sealants acting as an adjunct to sutures affect surgical outcomes. © 2001 Excerpta Medica, Inc. All rights reserved.
The use of sutures to aid wound closure dates back to 3500 BC, when it was first alluded to in an Egyptian scroll [1]. Today, suturing is still the most common method of wound closure, and recent advances in suture materials now allow surgeons to select the most appropriate suture for the particular wound or surgical intervention. Ideally, the chosen suture should provide mechanical support to a wound and create the optimal environment for wound healing until the tissue is sufficiently healed to withstand normal physical stress. In choosing an appropriate suture type for wound closure and healing, surgeons need to consider the strength of the suture, the type of tissue being held, and the absorbability of the sutures, because healing rates vary between tissues [2]. It is well known that tissue healing rates vary depending on the tissue; for example, skin heals much more quickly than fascia [2]. It has also been shown that skin wounds regain 85% of their original strength by day 15 [2]. However, many sutures start to lose their strength from day 3 to day 9, contributing little or no mechanical support from day 9 [3]. Furthermore, it has been reported that sutures fail to provide significant mechanical support for abdominal wounds between postoperative days 15 and 28 [4,5]. Complications associated with suturing in a variety of surgical interventions include mainly bleeding from sutures
Tel.: ⫹45 39 77 38 01; fax: ⫹45 39 77 76 44. E-mail address: [email protected]
and also air and fluid leakage. Bleeding from suture holes is a frequent occurrence in cardiothoracic and vascular surgery and may impact on postoperative morbidity and mortality [6]. The spray application of fibrin sealant may reduce perioperative hemorrhage during cardiac operations [6]. Resection of some parenchymal tissue may also lead to prolonged bleeding, and fibrin sealant has been used as an effective hemostat in diffuse bleeding organs where suturing is difficult or impossible [7]. Occasionally, fluid leakage may be a problem in gastrointestinal anastomosis (eg, esophageal and colorectal anastomosis), and in these difficult cases the application of fibrin sealants can reduce both fluid leakage and the potential risk of infection resulting from leakage. Suturing is the method of choice for wound closure. Inflammatory reactions and occasionally infections may occur as a result of sutures. However, the inflammation associated with sutures is not usually a problem for either the patient or the surgeon. A review of the literature indicates that reduced-suture fibrin sealant anastomosis and sutureless fibrin sealant anastomosis may be performed with less inflammation and necrosis compared with conventional suturing techniques [8]. Although many technologic advances have been made in surgical procedures and surgical materials (such as suture materials), reducing the incidence of complications is still of importance to surgeons. For many years, surgeons have been using fibrin sealant in conjunction with sutures (or
0002-9610/01/$ – see front matter © 2001 Excerpta Medica, Inc. All rights reserved. PII: S 0 0 0 2 - 9 6 1 0 ( 0 1 ) 0 0 9 1 0 - X
16S
H.K. Kjaergard / The American Journal of Surgery 182 (2001) 15S–20S
Fig. 1. Perioperative blood loss from the mediastinum is reduced after suture support [6]. *P ⬍0.05, unpaired Student’s t test.
alone) to improve the integrity of wound closure in terms of reduced hemorrhage from the suture line and suture holes [9 –13]. Indeed, in some surgical procedures a reduction in the number of stitches required to maintain wound closure is observed after the use of fibrin sealants. Some delicate tissues, such as lung parenchymal tissue, can also be closed with fibrin sealant. In addition, fibrin sealants do not initiate/ exacerbate an undue inflammatory response. The aim of this review is to compare the clinical outcome of the use of fibrin sealants as an adjunct to sutures in surgical practice to aid wound closure and healing.
Suture support To date, suture support has been described widely in the literature with varying definitions. Here we use suture support to describe the use of fibrin sealant as an adjunct to sutures after surgical intervention, resulting in additional mechanical support, prevention/reduction of needle hole and suture line bleeding, and an aid to healing.
Fibrin sealant in clinical practice Fibrin sealants were developed some 25 years ago as biologic tissue adhesives. The utility of fibrin sealants in cardiovascular surgery was recognized as early as the late 1970s [14]. Since then, fibrin sealants have been used in a wide range of surgical procedures, including cardiothoracic, head and neck surgery, thyroid surgery, neurosurgery, and vascular surgery to provide suture support. Hemostasis Postoperative blood loss after cardiac surgery requires re-operation in 4.4% of patients [15]. Fibrin sealants have
been used successfully in conjunction with sutures in cardiothoracic surgery to produce hemostasis. Indeed, fibrin sealant to support suture has been reported to be 94% or more effective at reducing blood loss after cardiovascular and thoracic surgery [16,17]. Control of blood loss from such sites as the mediastinum, specific sites at coronary artery bypass graft anastomoses, and long suture lines was achieved with the use of fibrin sealant [16]. This observation supports the earlier finding by Spotnitz et al [6] that perioperative hemorrhage from the mediastinum was significantly reduced by suture support. Blood loss in procedures using fibrin sealant as suture support at 12 and 24 hours was 461 mL and 714 mL, respectively, compared with 731 mL and 1,016 mL, respectively, for the control group (Fig. 1) [6]. The volume of blood lost during surgery is dependent on a number of factors, including use of intraoperative heparin, complexity of the surgery being performed, and the time taken to induce hemostasis. The use of fibrin sealants in surgery has been shown to significantly reduce the time to hemostasis with a beneficial effect on blood loss. In a randomized study in 17 patients undergoing surgery for carotid endarterectomy, suture support reduced suture line bleeding by 130 mL compared with the blood loss from patients who did not receive fibrin sealant [18]. In addition, the time to hemostasis in the suture support group was significantly lower at 5.5 minutes compared with 19 minutes in the control group (P ⱕ0.005; Table 1). Furthermore, 100% of patients in the control group required oxidized cellulose gauze to aid hemostasis compared with only 13% in the suture support group [18]. The observation that hemostasis was achieved more quickly in patients after suture support has been confirmed in another randomized study of peripheral vascular surgery. Hemostasis was achieved in 0.5 minutes in the suture support group compared with 4 minutes in the control group (P ⬍0.014; Table 1) [19]. Moreover, immediate hemostasis
H.K. Kjaergard / The American Journal of Surgery 182 (2001) 15S–20S Table 1 Time to hemostasis (mean range) after carotid endarterectomy and peripheral vascular surgery with or without fibrin sealant suture support Procedure
Study
Control (mins)
Fibrin sealant (mins)
P value
Carotid endarterectomy Peripheral vascular surgery
Milne et al, 1995 [18] Milne et al, 1996 [19]
19 (10–47)
5.5 (4–31)
0.005
4 (0–21)
0.5 (0–11)
0.014
was achieved on release of the clamps in 62% of patients in the suture support group compared with 22% in the control group [19]. These observations indicate that suture support can also be used as successfully in peripheral vascular surgery as it has been in cardiovascular surgery. Fibrin sealants have also been used successfully for hemostasis in neurosurgery for such procedures as arteriovenous malformation, middle cerebral artery aneurysm, orbital tumor, oligodendroglioma, meningioma, and ophthalmic aneurysm [20]. Indeed, suture support in patients undergoing surgery for intracranial artery aneurysm (n ⫽ 11) has been shown to be effective with no recurrent bleeding of the aneurysm in 100% of patients during the 25month follow-up period [20]. In most cases, local hemostasis was achieved within 1 minute of application of fibrin sealant [20]. The use of electrocautery, particularly in neurosurgery, is currently under review. In such sensitive tissues as the brain, where tissue damage can cause irreparable damage, electrocautery is used with caution. In these situations the use of fibrin sealant and sutures can reduce the need for this destructive technique. Blood loss associated with head and neck surgery is of concern to surgeons, especially as the rest (minimal movement of the head and neck) that is necessary to facilitate wound healing may not be taken for granted. Conservative or radical neck surgery performed for resection of malignant neoplasms of the oral cavity can leave large areas of raw tissue that can exude blood. The unavoidable rotation and flexion– extension movement of the neck may, in some cases, cause renewed bleeding. Fibrin sealant used in conjunction with suction drainage not only produced hemostasis, but also significantly reduced the volume of wound secretion after either radical or conservative neck surgery, during the first 2 postoperative days (P ⱕ0.05) [21]. Although the volume of wound secretion was greater after radical surgery compared with conservative surgery, the difference in secretory volume after the use of commercial fibrin sealant was not significantly different [21]. Fluid and air leakage Fibrin sealants have also been used in other surgical procedures, such as head and neck surgery and thoracic
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surgery, with success. In thyroid surgery, suture support significantly reduced the volume of fluid drained during the first postoperative night by approximately 50% (18 mL compared with 39 mL for suture alone; P ⱕ0.0001) [22]. Furthermore, the mean time to drain removal was 1.6 days in the fibrin sealant group and 2.2 days in the control group. This meant that patients in the fibrin sealant group were discharged from hospital after a mean of 2.8 days, with most patients leaving the day after drain removal. Overall, patients in the suture support group were discharged from hospital 0.9 days earlier than the control group. In this series of 30 patients, this translated to a saving of 27 bed days or the equivalent of approximately seven additional thyroidectomies. The cost difference between the two arms of the study was approximately $260 per patient in favor of fibrin sealant treatment or $7,900 per study group. Cost estimates were current for 1991 [22]. In 1990, Matthew et al [16] reported that the use of fibrin sealant in various thoracic and cardiovascular procedures was 100% (14 of 14 patients) successful in reducing fluid loss. Cerebrospinal fluid leakage is associated with complex neurosurgical procedures. Fibrin sealant has been used with success to prevent or stem cerebrospinal fluid leakage from pituitary tumor, metastatic tumors, oligodendroglioma, and cerebrospinal fluid rhinorrhea [20]. However, some cerebrospinal leakage was observed after the use of fibrin sealant in a few neurosurgical procedures [20]. In pulmonary resections, fibrin sealant has been shown to reduce blood loss from cut lung surfaces and bronchial anastomoses and to reduce air leakage with a success rate of 88% [16]. Fibrin sealant, in addition to reducing the incidence of air leakage, also reduced the frequency of postoperative air leakage with an estimated risk reduction of 41%. Furthermore, an improvement rate of 81% was obtained in the airway tolerance–pressure test in patients after suture support [23]. Mouritzen [23] also reported a significant reduction in length of hospital stay and a reduction in the number of patients in the fibrin sealant group with complications compared with controls. There was no estimate of cost saving reported for this study. Surgical time Surgical procedures that are intricate and/or complex, for example, vascular/microvascular surgery for digital replantation, can be time consuming. However, in the case of digital replantation, it is important to re-establish blood flow as soon as possible to reduce the ischemia induced by amputation. Techniques that shorten the operative time contribute to the success of digit replantation. Fibrin sealant has been used successfully as suture support in microvascular anastomoses in digit replantation surgery. The survival rate of digit replantation surgery after suture support (89%) was comparable with that reported for conventional microvascular surgery [24]. In addition, fibrin sealant–assisted mi-
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Fig. 2. Hydrostatic leak pressure (cm H2O) for skin tubes as a function of time (days) after suturing alone and with fibrin sealant treatment [32]. *0.05 ⬍ P ⬍ 0.10.
crovascular anastomosis did reduce the operative time by approximately 1.3 hours. This was a direct consequence of the reduced number of microsutures required at each anastomosis [24]. The development of safe, effective procedures that reduce operating times compared with conventional techniques has a positive impact on direct health-care costs. Adverse events Fibrin sealant is a product that uses blood-derived fibrinogen as one of its main constituents. The potential risk of transmission of blood-borne infection, such as hepatitis and human immunodeficiency virus, by fibrin sealants has been of concern to surgeons. However, to date there have been no documented reports of transmission of hepatitis or HIV infection from the use of fibrin sealant [25]. Indeed, at 6 months there was no serologic evidence of hepatitis A, B, or C, and no patients developed abnormal liver function tests during follow-up visits [18]. There is a rare but elevated risk of hypersensitivity reactions at re-exposure to aprotinin and immunization and bleeding from re-exposure to bovine thrombin. Most manufacturers have therefore switched over to human thrombin [26,27]. With appropriate precautions, re-exposure to aprotinin in patients, particularly those with a high risk of bleeding, is reported to be justified, and the benefits of aprotinin treatment are thought to outweigh the relative risk of a serious allergic reaction [28]. Animal studies The mechanical support offered by sutures with and without suture support with fibrin sealant cannot be determined in human subjects for obvious ethical reasons. Consequently, these studies are performed in animal models,
because it is important to determine the bursting pressure of sutures with and without suture support. Suture support Gastrointestinal anastomoses may occasionally leak, and colonic, low rectal, and esophageal anastomoses are more susceptible to leakage than other anastomoses despite good surgical technique. The option to use fibrin sealant gives the surgeon additional suture support and can reduce the potential risk of leakage in successful surgery. The leakage of colonic contents into the peritoneum can lead to peritonitis or sepsis with a fatal outcome. Fibrin sealant has been used experimentally to assess the suitability of suture support in colon anastomoses in an experimental rat model. Bursting pressures of 94 and 131 mm Hg were obtained for colonic anastomoses closed with suture support compared with 68 and 92 mm Hg for colonic anastomoses closed with sutures alone (1 mm Hg ⫽ 1.36 cm H2O) [29,30]. This additional firmness lasted for the duration of the 3-week observation period [29]. These findings are further supported by results in porcine stapled small bowel where suture support resulted in anastomoses that did not leak and showed only a mild inflammatory response compared with sutures alone [31]. Similar observations have been reported for skin wounds closed with sutures and suture support. Suture support resulted in watertight sutures immediately after surgery and increased the hydrostatic pressure resistance of skin sutures by 17.2 cm H2O (Fig. 2) [32]. At days 3 and 6, skin sutures supported with fibrin sealant were able to withstand increased hydrostatic pressures of 23.1 and 16.8 cm H2O, respectively (Fig. 2; 0.05 ⬍ P ⬍ 0.10) [32]. Similar results were reported for bladder sutures supported with fibrin sealant. These results suggest that the watertightness of
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conventional suturing can be improved with suture support. This could have clinical implications in urology, where a watertight suture may prevent urine extravasation in the wound and reduce or eliminate the associated complication of postoperative infection and the need for urinary diversion. As observed in the clinical setting, suture support has been shown to produce hemostasis in experimental models. Fibrin sealant has been reported to minimize blood loss after microvascular repair in hypertensive rats with no leakage or loss of patency of the anastomoses [33]. More recently, suture support was shown to significantly (P ⱕ0.05) reduce hemorrhage from carotid vascular grafts in a porcine model. The mean blood loss was 9.2 mL in the suture support group compared with 178.8 mL in the control group [34]. These results suggest that suture support would prevent leakage of blood after vascular and/or microvascular repair surgery, even in cases of high blood pressure. Suture support has also been used successfully in experimental delayed vasovasostomy in a rat model with results comparable to conventional suturing. However, after suture support only three sutures instead of the usual six sutures were required to produce similar anatomical results in vasal anastomoses. Furthermore, the mean operative time with fibrin sealant–assisted vasovasostomy was significantly shorter (P ⱕ0.001) than conventional suturing and was technically less demanding [35].
Conclusion The use of suture support in a broad spectrum of surgical procedures provides several advantages to the patient. The benefits of suture support include hemostasis, resulting in reduced blood loss from needle hole and suture line wounds, thus reducing the need for blood transfusion after such prolonged and complex surgical procedures as cardiovascular surgery; and a reduction in the drain volume and air leakage during thoracic and cardiac surgery, thereby shortening the time required for a chest drain, resulting in fewer days of discomfort for patients and in some cases a significant shortening of hospital stay. Suture support may also improve the success rate of some surgical procedures by reducing the complexity of the procedures, as has been observed in digit replantation surgery. Furthermore, suture support is safe and well tolerated by patients with no indication of viral infection from the fibrin sealant and few adverse reactions.
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