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Use of a plant-based polysaccharide hemostat for the treatment of sternal bleeding after median sternotomy


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In cardiac surgery profuse or persistent sternal bleeding after sternotomy is routinely controlled with bone wax. However, bone wax should be avoided, especially in high-risk patients for nonunion of the sternum and infections. Purpose of this study was to evaluate an alternative technique to control bleeding after medium sternotomy using a plant based absorbable polysaccharide hemostat. A consecutive series of 38 patients requiring median sternotomy for coronary artery bypass surgery (21 OPCAB, 17 CABG) had sternal bleeding control with the polysaccharide hemostat, STARSIL® HEMOSTAT. This hemostat is a hydrophilic powder, which achieves hemostasis after topical application at the surgical wound site. Initially it dehydrates blood rapidly, thus accelerating aggregation of platelets and blood solids. Thereafter, it forms a gelled adhesive matrix, which serves as a mechanical barrier against further bleeding. The polysaccharide is completely resorbed within 48 to 72 hours. Satisfactory control of sternal bleeding was observed in 37 patients (97%). No product-related complications were observed or any other major adverse events in an observation period of 3 months. Polysaccharide hemostats appear to be safe and effective for bleeding control of the sternum.
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RES E A R C H A R T I C L E Open Access
Use of a plant-based polysaccharide hemostat
for the treatment of sternal bleeding after
median sternotomy
Christoph Schmitz
and Ralf Sodian
Background: In cardiac surgery profuse or persistent sternal bleeding after sternotomy is routinely controlled with
bone wax. However, bone wax should be avoided, especially in high-risk patients for nonunion of the sternum
and infections. Purpose of this study was to evaluate an alternative technique to control bleeding after medium
sternotomy using a plant based absorbable polysaccharide hemostat.
Methods: A consecutive series of 38 patients requiring median sternotomy for coronary artery bypass surgery
(21 OPCAB, 17 CABG) had sternal bleeding control with the polysaccharide hemostat, STARSIL® HEMOSTAT. This
hemostat is a hydrophilic powder, which achieves hemostasis after topical application at the surgical wound site.
Initially it dehydrates blood rapidly, thus accelerating aggregation of platelets and blood solids. Thereafter, it forms
a gelled adhesive matrix, which serves as a mechanical barrier against further bleeding. The polysaccharide is
completely resorbed within 48 to 72 hours.
Results: Satisfactory control of sternal bleeding was observed in 37 patients (97%). No product-related complications
were observed or any other major adverse events in an observation period of 3 months.
Conclusion: Polysaccharide hemostats appear to be safe and effective for bleeding control of the sternum.
Keywords: Bleeding control, Sternotomy, Polysaccharide hemostats
Profuse bleeding or persistent oozing after sternot omy is
routinely controlled with bone wax. However, bone wax,
which cannot be absorbed by the body, has been shown
to inhibit osseous fusion, promote infections, and elicit
inflammatory reactions [1-3]. Nowadays, an increasing
number of patients requiring sternotomy are at high risk
for sternal instability and wound healing complications.
Therefore improved methods for bleeding control of the
sternum without using bone wax are demanded [4,5].
We present here an alternative to control sternal blee-
ding after sternotomy using a hemostatic powder.
A consecutive series of 38 patient s requiring median
sternotomy for coronary artery surgery (21 OPCAB and
17 CABG) wer e included into the study. 35 patients pre-
sented with preoperative platelet inhibition (21 single
and 14 dual platelet inhibition). Additional demographic
patent data are listed in Table 1. For study purposes sur-
geons rated the performance of STARSIL® HEMOSTAT
using a visual analogue scale (VAS) from 1 to 10. One
was a very bad, 10 a perfect performance of the product.
All patients were followed-up for three months.
Study product
Velen, Germany) is a hemostat consisting of 5 g purified
plant-based absorbable polysaccharide that can be ad-
ministered to the entire operation area. It is a second
generation starch-based hemostat. When compared to a
first generation product, it has distinct advantages, e.g.
significantly increased water absorption quantity (here:
64 ml/2 g powder). The powder is available off-the-shelf
* Correspondence:
Department of Cardiac Surgery, University of Munich, 81377 Munich,
© 2015 Schmitz and Sodian; licensee BioMed Central. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (, which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public
Domain Dedication waiver ( applies to the data made available in this
article, unless otherwise stated.
Schmitz and Sodian Journal of Cardiothoracic Surgery (2015) 10:59
DOI 10.1186/s13019-015-0263-4
without any further preparation. In order to obtain
hemostasis it can be applied directly onto a bleeding
wound. The hemostatic effect results from rapid dehy-
dration and subsequent concentration of blood compo-
nents like red blood cells, platelets and serum proteins
(thrombin, fibrinogen, etc.), thus accelerating the clot-
ting cascade. As a result a gelled adh esive matrix is pro-
duced. Normal platelet activation and fibrin deposition
produce a clot that functions as a mechanical barrier
and limits further bleeding. Absorption of the particles
is achieved within approximately 48 to 72 hours. STAR-
SIL® HEMOSTAT is biocompatible, non-pyrogenic and
does not contain any allo- or xenogenic additions.
Application technique
Skin incision and median sternotomy were performed with
standard techniques trying to use electrocautery sparingly.
Directly after sternotomy STARSI HEMOSTAT was ap-
plied on each side of the sternal spongiosa (Figure 1).
Towels were wrapped around the sternum for atraumatic
tissue treatment before insertion of the retractor. Bleeding
control was rated satisfactory, when bleeding from the
sternal spongiosa was achieved within one minute. After
sternotomy patients were fully heparinized (activated
clotting time > 400 seconds) and open-heart surgery was
performed in a routine fashion. After graft placement
protamine was administered in order to reverse the
heparin effect. Before sternal closure residual STARSIL®
HEMOSTAT was applied on both sides of the sternum
(Figure 2). Sternum was closed with sternal wires, sub-
cutaneous fat and skin with absorbable sutures.
Satisfactory control of sternal bleeding was observed in
37 cases (97%). In all but two patients a single applica-
tion of the hemostat led to satisfactory results. The two
additional patients showed persistent bleeding requiring
a second application of STARSIL® HEMOSTAT. One
surgeon rated a second application as non satisfactory
while the other had no problem using the powder a se-
cond time. Surgeons general satisfaction according to
the VAS was 8.4 ± 1.4 (Table 2).
No adverse events or allergic reactions were observed
during the study period. There were no ca ses of in-
hospital mortality or product related morbidity observed
during the 3-month follow-up. No re-operations due to
graft alteration, bleeding or unstable sternum were ne-
cessary. No patient required sternal re-fixation due to
Table 1 Demographic data of patients receiving STARSIL®
HEMOSTAT for sternal bleeding control
OPCAB (n) 21
CABG (n) 17
Age (years) 67 ± 14
RITA/LITA (n) 15
COPD (n) 14
Diabetes (n) 16
Severe osteoporosis (n) 9
BMI > 30 (n) 6
Platelet inhibition
No 3
Single (ASA) 21
Dual 14
OPCAB: off-pump coronary artery bypass; CABG: coronary arterial bypass
grafting; RITA: right internal thoracic artery; LITA: left internal thoracic artery;
COPD: chronic obstructive pulmonary disease; BMI: body mass index;
ASA: acetyl salicylic acid.
Figure 1 STARSIL® HEMOSTAT applied on both sides of the sternum after median sternotomy.
Schmitz and Sodian Journal of Cardiothoracic Surgery (2015) 10:59 Page 2 of 4
instability. Two patients experienced superficial woun d
infections. The first patient required an outpatient pro-
cedure in which the wound was cleaned. Subsequently,
secondary wound-closure was performed. In the second
patient the wound was treated con servatively with daily
wound dressings for three weeks. Another patient was
re-administered six weeks postoperatively for sternal
wire extraction due to chest pain. All postoperative
events were rated as not product related.
Surgeons commonly recommend to avoid the use of
bone wax for control of sternal bleeding, especially in
patients at a high risk for infection or nonunion [6].
Furthermore, bone wax is often ineffective in elderly
patients and those with osteoporosis; additionally, the
spongiosa scaffold of the sternum is destroyed when ap-
plying bone wax, which may result in the marrow cavity
absorbing large quantities of wax without hemostasis.
Despite the negative effects associated with the use of
bone wax, the product remains in widespread use, pre-
sumably due to the perceived lack of suitable alterna-
tives. In our study STARSIL® HEMOSAT proved to be a
simple, safe and effective alternative for bleeding control
in patients undergoing median sternotomy. Results were
very satisfactory in most cases, even when applied under
difficult conditions, e.g. when dual platelet inhibition
was necessary.
Other hemostatic agents like fibrin sealant or microfi-
brillar collagen may also be helpful. But when compared
to polysaccharide hemostats they are relatively expen-
sive. Furthermore, it has been published that the use of
fibrin glue may increase morbidity in cardiac surgery [7].
Microfibrillar collagen has also been used to reduce
sternal bleeding. However, due to the small diameter of
its needle-shaped structure, there is a risk for passing
filters of blood salvage system, thus entering patients
circulation, and possibly resulting in organ damage [8].
Starch-based hemostats are in clinical use for more than
10 years. STARSIL® HEMOSTAT is a second generation
starch-based hemostat. When compared to Arista (Medafor
Inc., Minneapolis, MN, USA), a first generation product,
STARSIL® HEMOSTAT has distinct advantages, e.g. sig-
nificantly increased water absorption quantity.
Another interesting feature of starch-based hemostats
seems to be an adhesion barrier function, which was de-
scribed in an animal model [9]. In a study on Wister
outbred rats a relationship between inflammation and
tissue necros is as well as the possible formation of adhe-
sions could be demonstrated. Six different hemostatic
agents were tested. The starch-based hemostat proved to
produce significantly lower adhesion formation when
compared to control (p < 0.05).
There are some limitations that should be pointed out:
In our observation we had two different patient groups
with either on- or off-pump surgical revascularization.
Therefore the study represents small patient groups with
a relatively short median follow-up time. The study re-
flect s as well a single center experience of two expe-
rienced surgeons. We already planned a larger multicenter
Figure 2 STARSIL® HEMOSTAT applied on both sides of the sternum after sternotomy before closure with steel wires.
Table 2 Intra- and postoperative results of patients
receiving STARSIL® HEMOSTAT for sternal bleeding control
Satisfactory bleeding control (n) 37 (97%)
Preop. (g/dL) 12.6 ± 1.2
Direct postop. (g/dL) 9.1 ± 1.8
On discharge (g/dL) 12.7 ± 1.6
Drainage 6 h (mL) 480 ± 380
Cell saver (ml) 360 ± 210
Blood units (U) 26/19 pts
Result of VAS 8.4 ± 1.4
VAS: visual analogue scale.
Schmitz and Sodian Journal of Cardiothoracic Surgery (2015) 10:59 Page 3 of 4
trial with more patients which will confirm the clinical
safety and efficacy of STARSIL® HEMOSTAT in all
surgical settings. There are some polysaccharide based
hemostatic powders on the market that already demon-
strated advantages and limitations when compared to
other hemostatic agents. Therefore we did not compare
different groups in this study. Furthermore the primary
endpoint was safety of use of STARSIL® HEMOSTAT
when applied for bleeding control of the sternum.
In conclusio n, polysaccharide hemostats, like STARSIL®
HEMOSTAT, appear to be safe and effective controlling
sternal bleeding in cardiac surgery. Furthermore, they
may help to reduce wound-healing complications asso-
ciated with use of bone wax.
Written informed consent was obtained from the patient
for the publication of this report and any accompanying
VAS: Visual analogue scale.
Competing interests
Both authors declare that they have no competing interests.
Authors contributions
CS: including patients, performed surgery, performed statistical analysis,
drafted manuscript, wrote manuscript. RS: including patients, performed
surgery, drafted manu script, revised manuscript, approved manuscript.
Both authors read and approved the final manuscripts.
Received: 2 October 2014 Accepted: 17 April 2015
1. Angelini GD, el-Ghamari FA, Butchart EG. Poststernotomy pseudo-arthrosis
due to foreign body reaction to bone wax. Eur J Cardiothorac Surg.
2. Nelson DR, Buxton TB, Luu QN, Rissing JP. The promotional effect of bone
wax on experimental staphylococcus aureus osteomyelitis. J Thorac
Cardiovasc Surg. 1990;99:97780.
3. Wellisz T, Armstrong JK, Cambridge J, Yuehuei H, Wen X, Hill CM, et al. The
effects of a soluble polymer and bone wax on sternal healing in an animal
model. Ann Thorac Surg. 2008;85:177680.
4. Abboud CS, Wey SB, Baltar VT. Risk factors for mediastinitis after cardiac
surgery. Ann Thorac Surg. 2004;77:67683.
5. Diez C, Koch D, Kuss O, Silber RE, Friedrich I, Boergermann J. Risk factors for
mediastinitis after cardiac surgery a retrospective analysis of 1700 patients.
J Cardiothorac Surg. 2007;2:23.
6. Kirklin JW, Barratt-Boyes BG, Kirklin JW, Barratt-Boyes BG. The incision-
primary median sternotomy. In: Kirklin JW, Barratt-Boyes BG, Kirklin JW,
Barratt-Boyes BG, editors. Cardiac Surgery, Vol 1. New York: Churchill
Livingstone; 1993. p. 101.
7. Lamm P, Adelhard K, Juchem G, Weitkunat R, Milz S, Kilger E, et al. Fibrin
glue in coronary artery bypass grafting operations: casting out the devil
with Beelzebub? Eur J Cardiothorac Surg. 2007;32:56772.
8. Robicsek F, Duncan GD, Born GVR, Wilkinson HA, Masters TN, McClure M.
Inherent dangers of simultaneous application of microfibrillar collagen
hemostat and blood saving devices. J Thorac Cardiovasc Surg.
9. Hoffmann NE, Siddiqui SA, Agarwal S, McKellar SH, Kurtz HJ, Gettman MT,
et al. Choice of hemostatic agent influences adhesion formation in a rat
cecal adhesion model. J Surg Res. 2009;155:7781.
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Schmitz and Sodian Journal of Cardiothoracic Surgery (2015) 10:59 Page 4 of 4
... No allergic reactions or adverse events were noted up to 3 months follow-up. Five percent (2/38) presented with superficial wound infection; one of them was treated conservatively and the other in an outpatient setting [34]. ...
... Autologous platelet-rich plasma bags given intraoperatively has shown to decrease the volume of other whole blood products needed intraand post-operatively. Postoperative EPO could be given in order to achieve desired Hb levels after intraoperative blood loss [19,21,23,26,28,29,34]. ...
Emerging evidence suggests surgical outcomes of patients undergoing cardiovascular surgery that refuse autologous transfusion is comparable to those who accept whole blood product transfusions. There are several methods that can be used to minimize blood loss during cardiovascular surgery. These methods can be categorised into pharmacological measures, including the use of erythropoietin, iron and tranexamic acid, surgical techniques, like the use of polysaccharide haemostat, and devices such as those used in acute normovolaemic haemodilution. More prospective studies with stricter protocols are required to assess surgical outcomes in bloodless cardiac surgery as well as further research into the long-term outcomes of bloodless cardiovascular surgery patients. This review summarizes current evidence on the use of pre-, intra-, and post-operative strategies aimed at the subset of patients who refuse blood transfusion, for example Jehovah's Witnesses.
... [5][6][7][8][9][10][11][12][13][14] More recently, the benefit of using powdered hemostats intraoperatively to treat low-level bleeds has been demonstrated clinically. [15][16][17][18][19][20] The two predominant materials within this class of hemostatic agents are a polysaccharide-based powder and a fibrinogen-thrombin based powder. While greater clinical evidence exists for the fibrinogen-thrombin based powder, polysaccharide powders are favored due to their fast degradation and minimal inflammatory response. ...
... MPH were selected as a comparator because of their similar delivery and use as a powdered hemostatic agent for which the clinical acceptability and biocompatibility characteristics have been established. 15,20 The MPH is provided pre-loaded into a disposable plastic bellows and arrives in a sterile packaged configuration. The 1 gram size was utilized for these studies. ...
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Purpose/Aim: Powdered hemostats have been widely adopted for their ease-of-use; however, their efficacy has been limited resulting in applications restricted to low-level bleeds. This study investigates the use of bovine-derived gelatin particles (BGP) as a standalone hemostatic powder and compare BGP to commercially available microporous polysaccharide hemospheres (MPH). Materials and Methods: The powders were investigated for their hemostatic efficacy in a heparinized pre-clinical bleeding model limited to grade 1 and 2 bleeds on a validated intraoperative bleeding scale, which represents the accepted, clinical use of hemostatic powders. Results: At 10 minutes, the hemostatic success of lesions treated with BGP were 78% while MPH were 22%. The odds ratio for hemostatic success of BGP relative to MPH was 15.18 (95% CI: 7.37, 31.27). The 95% lower limit of the odds ratio was greater than 1. This indicates that BGP are superior to MPH (p < 0.001). The median time to hemostasis for BGP was 1.6 minutes and MPH was 14.5 minutes. The ratio for time to hemostasis of MPH relative to BGP was 9.23 (95% CI: 6.99, 12.19). This indicates that BGP achieve significantly faster time to hemostasis (p < 0.001). Conclusions: Characterization of tissue explant ultrastructure, particle size, and swelling revealed differences in the materials. BGP, in addition to absorbing fluid and concentrating clotting factors and platelets, integrate into the clot and stabilize the fibrin matrix. BGP have advantages over MPH in terms of speed and efficacy. BGP are a favorable biomaterial for further research that greatly improve the limited efficacy of powdered hemostats.
... In our current study we have elected to use Starsil® Hemostat, a plant-derived hemostatic powder that is commonly used for treatment of sternal bleeding after median sternotomy [22]. According to Hemotec Medical GmbH, the use of Starsil makes it possible to achieve bleeding control in diverse cardiac operations such as coronary-arterial bypass graft (CABG), implantation of pacemaker or an implantable cardioverter defibrillator (ICD), replacement of ascending aorta for repair of aortic aneurysm, aortic valve replacement and even heart transplantations [23]. ...
... Polysaccharide-based hemostats: Polysaccharide hemostats, like STARSIL® and HEMOSTAT, seems to be useful in bleeding control. It is widely used in cardiac surgery procedures 20 . Reduction of wound healing complications (mostly seen after using bone wax) can be considered as additional. ...
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Intraoperative or postoperative bleeding during any periodontal surgical procedure can to some serious complications. Difficulties related to bleeding can be seen in both healthy individuals as well as bleeding disorder patients, any systemic complications and patients under anticoagulant drug therapy. Having a clear perspective about the preventive measures to be taken to control the profuse bleeding is a must for a practitioner. The purpose of the literature review is to discuss the administration of different types of hemostatic agents available for controlling bleeding. © 2020, Institute of Medico-Legal Publications. All rights reserved.
... 18 Previous authors have examined the retrospective performance of a powdered hemostatic agent 18 as well as the prospective comparative performance of hemostatic agents including powders in cardiothoracic procedures. 15,[19][20][21][22][23][24][25][26][27][28][29][30] However, to the best of our knowledge, this report presents the first direct comparison of 2 powdered hemostatic agents during cardiac surgical procedures. ...
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This clinical study compares 2 hemostatic agents, a novel combination powder (CP) (HEMOBLAST ™ Bellows) and an established polysaccharide starch powder (PP) (Arista ™ AH) to assess the usefulness of CP. Retrospective comparative analysis of CP (July 2018 to July 2019, 68 patients) to PP (January 2011 to January 2013, 94 patients) in cardiothoracic patients was performed using linear regression models adjusting for age, sex, and procedure type for the endpoints: blood loss; protamine to skin closure time (hemostasis time); chest tube output and blood products required 48 hours postoperatively; ICU stay; postoperative comorbidities; and 30 day mortality. 162 patients (108 M: 54 F) underwent 162 cardiothoracic surgical procedures including: transplantation (n = 44), placement of ventricular assist device (n = 87), and others (n = 31). Use of CP compared to PP (Estimated Mean Difference [95% CI], P-value) produced significant reductions: blood loss (mL) (−886.51 [−1457.76, −312.26], P = 0.003); protamine to skin closure time (min) (−16.81 [−28.03, −5.59], P = 0.004); chest tube output (48 hrs, mL) (−445.76 [−669.38, −222.14], P < 0.001); packed red blood cell transfusions (units) (−0.98 [−1.56, −0.4], P = 0.001); and postoperative comorbidities (−0.31 [−0.55, −0.07], P = 0.012). There were no differences in the ICU stay (4.07 [−2.01, 10.15], P = 0.188) or 30-day mortality (0.57 [0.20, 1.63], P = 0.291). The use of CP in complex cardiothoracic operations resulted in improved hemostasis and significant clinical benefits in blood loss, transfusion requirements, morbidity, and time in operating room.
... It has wide applications in cardiovascular surgery for bleeding control of sternotomy edges in 37/40 patients. 14 Then, in ear, nose, and throat surgery, some authors applied as a hemostatic agent in several neck dissections, parotidectomy, tonsillectomy, and endoscopic sinus surgery. [15][16][17] Some authors have reported good results in laparoscopic prostatectomy, and persistent bleeding from neurovascular bundles was also stopped. ...
Efficient hemorrhage control of severe wound injuries is an urgent medical need, deserving agents with promising blood coagulation and biocompatible characteristics. Current work developed polydopamine (PDA) functionalized porous starch powder (PS-PDA) for emergency bleeding treatment. The micro-morphology and elements, chemical groups, and porosity of PS-PDA were systematically characterized. Its comparison with porous starch (PS) revealed the promising potential of this composite in medical practice. On one hand, PS-PDA showed superior surface area and biomineralization affinity over PS, along with comparable hemo/cyto-compatibility. On the other hand, the photothermal effect of PDA under near Infrared (NIR) light paved the possibility to accelerate blood coagulation in situ. In vivo studies indicated PS-PDA can significantly reduce blood loss and improvement of hemostasis efficiency accompanied by NIR light exposure. These results suggest that this newly developed PS-PDA powder can serve as a promising hemostatic material for bleeding wound control.
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Tumor resection of advanced pelvic and recurrence pelvic cancers is highly challenging, because the resections often are performed outside the standard surgical resections planes, and therefore are associated with considerable morbidity and mortality. Knowledge of normal anatomy combined with improved imaging modalities and new technology give the best‐possible preparation to clarify the tumor specifics, including involved vasculature and nerves, and can help plan reconstruction. One of the most substantial side effects of advanced pelvic surgery is functional impairment due to nerve damage after a further successful resection. The sciatic nerve is formed from a collection of fibers involving L4‐S3 roots. The management of abdominal compartment syndrome often requires surgical decompression by opening of the abdominal wound. Multivisceral resection often outside normal surgical planes is associated with a higher rate of complications and careful intraoperative strategies must be established to deal with complications.
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Hemostatic agents are frequently used during abdominal surgery and some are linked to adhesion formation. We sought to evaluate the impact of several commonly used hemostatic agents on adhesion formation in a rat peritoneal model. In our study, Wister outbred rats underwent laparotomy and excision of a portion of their peritoneum to initiate adhesion formation process. One of six different hemostatic agents, namely, activated starch microspheres (Arista AH; Medafor Inc., Minneapolis, MN), glutaraldehyde activated collagen (BioGlue; Cryolife Inc., Kennesaw, GA), thrombin coated collagen microspheres (FloSeal; Baxter Inc., Deerfield, IL), thrombin activated fibrin polymer (Tisseel, Baxter), polyethylene glycol polymer (CoSeal, Baxter), or oxidized cellulose (Surgicel; Ethicon Inc., Somerville, NJ), was placed in the area of peritoneal defect. All animals were sacrificed on post-op day 7 and strength and extent of adhesion formation was determined. Histopathological examination of rat caecum was also performed. Arista and CoSeal showed significantly lower adhesion formation than controls (P < 0.05). Higher adhesion scores were seen in BioGlue (P < 0.05) treated rats. Additionally, histopathologic examination showed that BioGlue caused statistically more inflammation and necrosis than controls (P < 0.05). Total adhesion score increased with residual amount of agent present at 7 d. Use of Arista and CoSeal may help in reducing peritoneal adhesions after intra-abdominal surgeries. Furthermore, there appears to be a relationship between the creation of inflammation and necrosis in tissues and the eventual formation of adhesions. This could aid in improving the design of these agents in the future.
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Mediastinitis is a rare, but serious complication of cardiac surgery. It has a significant socioeconomic impact and high morbidity. The purpose of this study was to determine pre-, intra-, and postoperative predictors of mediastinitis. In 1700 consecutive patients, who underwent cardiac surgery in 2001, 49 variables were retrospectively assessed. Forty-five patients (2.65%, 95% CI [1.88; 3.41]) developed postoperative mediastinitis. None of these patients died during their hospitalization. Multivariate analysis identified three of the 49 variables as highly significant independent predictors for the development of mediastinitis: obesity (OR 1.03, 95% CI [1.01; 1.04] p = 0.001), chronic obstructive pulmonary disease (OR 3.30, 95% CI [1.58; 6.88], p = 0.001), and bilateral grafting of the internal mammary artery (OR 3.18, 95% CI [1.20; 8.43] p = 0.02). The model is reliable in terms of its goodness of fit, it also discriminates well. Additionally, univariate analysis identified diabetes mellitus, CCS class and the number of intraoperatively transfused units of fresh frozen plasma as variables with a significant impact. The present study suggests that bilateral IMA grafting, chronic obstructive pulmonary disease and obesity are important predictors of mediastinitis.
The consequences of using surgical bone wax are not well studied. We evaluated the infection-promoting potential of sterile bone wax in a rat model of chronic Staphylococcus aureus osteomyelitis. The addition of bone wax greatly reduced the quantitative bacterial inoculum (log colony-forming units) required to establish chronic osteomyelitis in 50% and 100% of challenged animals. The 50% infection rate was reduced from log 6.9 to 2.6 and the 100% infection rate from 8.2 to 4.4, respectively (p less than 0.015, t test for parallelism). Separate experiments were done 10 to 30 minutes after inoculation with only log 6.4 staphylococci. Tibiae of animals that received bone wax yielded more organisms than those that did not (log 2.76 +/- 0.68 versus 1.72 +/- 0.94, p less than 0.01). At 24 hours quantitative colony counts were not significantly different whether animals received wax or not (log 5.02 +/- 0.42 versus 4.43 +/- 0.65, p greater than 0.09). These studies suggest that the routine surgical use of bone wax should be reassessed.
A case of repeated pseudo-arthrosis of the sternum following two median sternotomies for coronary artery bypass surgery is reported. This was due to a chronic foreign body reaction to the bees' wax used during the first operation to reduce bleeding from the sternal edges.
Microfibrillar collagen hemostat is a topically applicable hemostatic agent that has been introduced relatively recently. Because of the possibility that this substance may pass through different blood-collecting circuits and cause organ damage if reintroduced into the patient's circulation, we performed a series of in vitro and in vivo experiments. The results of these experiments suggest that such a passage may indeed occur and could cause organ damage, either by direct or by induced embolization that cannot be completely prevented even with the application of commercially used filters. We therefore recommend that the substance should not be used if the shed blood is intended to be collected and returned into the patient's circulation.
Postoperative mediastinitis is one of the most feared complications in patients who undergo cardiac surgery because in addition to a high mortality rate (10% to 47%), there are increases in the length of hospital stay and in hospital costs. The purpose of the present study is to assess the risk factors for mediastinitis after cardiac surgery, the mediastinitis rate, and the mortality rate in our institution. To determine the risk factors, a matched case-control study was carried out, with 39 cases and 78 controls, among the patients who underwent cardiac surgery at the Dante Pazzanese Cardiology Institute, São Paulo, Brazil. In the period of the study, 9,136 cardiac surgeries were performed and the mediastinitis rate was 0.5%. In the multivariate analysis, the independent risk factors found were obesity (odds ratio, 6.49; 95% confidence interval, 2.24 to 18.78), smoking (odds ratio, 3.27; 95% confidence interval, 1.04 to 10.20), intensive care unit stay more than 2 days (odds ratio, 4.50; 95% confidence interval, 1.57 to 12.90), and infection at another site (odds ratio, 8.86; 95% confidence interval, 1.86 to 42.27). The mortality rate was 23% among the patients with mediastinitis. We observed two independent risk factors related to patients' antecedents (obesity and smoking) and two risk factors related to problems in the postoperative period (length of intensive care unit stay and infection at another site). Efforts should be concentrated so that patients lose weight and stop smoking before elective surgeries. There should also be a prevention program against hospital infection directed to, and intensified for, at-risk patients.
Fibrin sealants are frequently used in aortocoronary bypass operations. Although they are considered to be clinically safe, we performed a retrospective analysis of our data to examine the possible side effects of Tissucol fibrin sealant, namely the acute thrombosis of grafts and native coronary arteries resulting in severe myocardial damage and patient deaths. The data of 2716 patients (2001 male, 715 female) who received an aortocoronary bypass operation from November 1995 to December 1999 were studied retrospectively. Two groups (group 1: received Tissucol, group 2: no sealant used) were compared with respect to an a priori selected set of demographic and clinical variables and with respect to their effect on the outcome using bivariate tabulation. Multiple exploratory assessments of factors possibly related to fatal outcome were done by multiple logistic regression. Nine hundred ninety patients (group 1) received Tissucol, 1726 patients (group 2) did not receive it. Mean patient age was 64+/-9.1 years. Group 1 had a higher risk of death (7.8% vs 2.8%, p<0.001). The peak values of creatine kinase >500 and creatine kinase-myocardial band >50 were higher in group 1 than in group 2, p<0.001. Adjusted odds ratios for the risk of fatal outcome were: 2.01 for the use of Tissucol, 2.71 for patient age >70 years, 2.02 for aortic cross clamp time >90 min, 3.95 for postoperative ventricular fibrillation, 6.35 for postoperative cardiopulmonary resuscitation, 4.55 for postoperative aortocoronary reoperation. In our analysis an increased risk of myocardial injury or even death was found in coronary artery bypass grafting patients when Tissucol fibrin sealant was used intraoperatively.
This study compares the effects of a soluble polymer hemostatic material and bone wax on sternal bone healing. Median sternotomies were performed on 20 New Zealand White rabbits, and sufficient polymer (Ostene; Ceremed Inc, Los Angeles CA) or bone wax (Bone Wax; Ethicon Inc, Somerville, NJ) was applied to achieve bone hemostasis. After 6 weeks, sternal healing was assessed using roentgenograms, histology, and mechanical strength testing. Roentgenograms revealed normal bone healing in the polymer-treated group and nonunion in the bone wax group. Histology showed normal bone healing in the polymer group, with fibrotic scar tissue and the absence of new bone formation in the bone wax group. Mechanical strength testing showed that polymer-treated sternal segments were twice as strong as those treated with bone wax. They had a significantly higher flexural strength (2.53 +/- 0.43 vs. 1.29 +/- 0.37 megapascal [MPa]; p < 0.001) and Young's modulus (0.315 +/- 0.056 vs 0.146 +/- 0.031 MPa; p < 0.001). The application of the polymer hemostatic material to the sternum resulted in significantly stronger union compared with the use of bone wax.