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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
Abstract
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
Background
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.
Methods
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
STARSIL® HEMOSTAT (HEMOTEC MED ICAL GmbH,
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: Christoph.Schmitz@med.uni-muenchen.de
Department of Cardiac Surgery, University of Munich, 81377 Munich,
Germany
© 2015 Schmitz and Sodian; licensee BioMed Central. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) 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 STARSIL® 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.
Results
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. Surgeon’s 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.
Discussion
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 patient’s
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).
Limitations
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%)
Hemoglobin
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.
Conclusion
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.
Consent
Written informed consent was obtained from the patient
for the publication of this report and any accompanying
images.
Abbreviation
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
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