Reduction of postoperative bleeding following operative treatment of proximal humerus fractures using a collagen sponge

doi:10.4236/health.2010.212211

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Vol.2, No.12, 1421-1424 (2010) Health

doi:10.4236/health.2010.212211

Reduction of postoperative bleeding following operative

treatment of proximal humerus fractures using a

collagen sponge

Sylvia Doleschal1, Thomas Schmickal1, Alexander Schuh2

1Department of Trauma Surgery, Neumarkt Hospital, Neumarkt, Germany;

2Research Unit Orthopedics and General Surgery, Neumarkt Hospital, Neumarkt, Germany;

*Corresponding Author: Alexander.Schuh@klinikum.neumarkt.de

Received 15 September 2010; revised 18 October 2010; accepted 20 October 2010

ABSTRACT

Aim of the present study is to investigate the

efficacy and safety of TachoSil® to reduce

afterbleeding and hematoma following operative

treatment of proximal humerus fractures. In a

prospective randomized study we included a

consecutive series of 40 patients with a proximal

humeral fracture in this study. All fractures were

stabilized surgically with a fixed-angle “Philos

plate” from May 2008 through May 2009. All

patients were divided in two groups: Group I

with plate osteosynthesis without TachoSil,

Group II with plate osteosynthesis with TachoSil.

For st atistical analysis Chi2-Test and U-Test were

used. There were 4 perioperative complica-

tions in group II and one complication in group I

(Chi2-Test: p = 0.233). In group II one hardware

failure occurred due to osteoporosis requiring

revision and reosteosynthesis. Another patient

suffered from paralysis of the radial nerve which

healed uneventfully. One superficial postope-

rative infection and one superficial hematoma

required revision surgery, too. In this group no

subfascial hematoma developed. One subfascial

hematoma which required no revision occurred

in group I. Blood transfusion was required 2

times in group I and 3 times in group II (Chi2-Test:

p = 0.549). In sum in group II there w as a signif-

icant lower blood loss for the subfascial drain,

the region where TachoSil was applied. No ad-

verse affects related to TachoSil could be de-

tected. TachoSil was found to be safe and

effective for reduction of postoperative bleeding

following operative treatme nt of proximal h um e ru s

fractures. Further studies with larger sample

size are required to confirm the efficacy of

TachoSil® in orthopedic surgery.

Keywords: Hematoma; TachoSil; Proximal Hume-

rus Fracture; Plate Osteosynthesis; Reduction

1. INTRODUCTION

Proximal humerus fractures are increasingly common

in the elderly [1]. The majority of proximal humerus

fractures are minimally displaced and can be successfully

treated non-operatively with early rehabilitation. Opera-

tive treatment methods range from head-preserving

stabilization to total joint replacement depending on the

extent of displacement and fragmentation. There are

various surgical head-preserving methods with different

kinds of plates, external fixation, intramedullary devices

and K-wire procedures, sometimes combined with the

use of anchoring devices [1-6]. Several new locked plate

devices have been developed because research suggests

plates with attached (locked) screws may provide im-

proved fracture stability and healing. Locking the screw

to the plate mechanically recreates a point of cortical

bone contact, which may be useful in the poor cancellous

bone of the proximal humerus. Locking plates also have a

preconfigured shape and screw direction, which may

reduce hardware complications [1,4]. Postoperative com-

plications include superficial postoperative infections (8-

10.3%) [4,7] and hematoma (4.6%) requiring revision

surgery [4]. TachoSil and its predecessor products,

TachoComb® and TachoComb H, have been used in a

variety of surgical settings since being introduced in the

early 1990s. TachoSil is indicated for supportive treatment

in surgery for improvement of haemostasis, to promote

tissue sealing, and for suture support in vascular surgery

where standard techniques are insufficient. Clinical

studies have shown that TachoSil is effective in achieving

haemostasis after kidney or liver resection [8-13].

TachoSil® is a sterile, absorbable, haemostatic agent that

consists of an equine collagen patch coated on one side

S. Doleschal et al. / Health 2 (2010) 1421-1424

1422

with human fibrinogen and human thrombin. Unlike

other fibrin sealants that require preparation before use,

TachoSil is a ready-to-use fixed combination that is

activated by moisture on application, providing adherence

to the resection surface and haemostasis. The adhesive

strength of TachoSil has been shown to be significantly

higher than that of liquid fibrin glue and the effect of the

fibrinogen and thrombin together with the mechanical

support of the collagen patch provides a physiologically

extensible and pliable liquid and air tight seal [9].

Aim of the present study is to investigate the efficacy

and safety of TachoSil® to reduce afterbleeding and

hematoma following operative treatment of proximal

humerus fractures using an interlocking plate.

2. MATERIAL AND METHODS

In a prospective randomized study we included a

consecutive series of 40 patients with a proximal

humeral fracture. All fractures were stabilized surgically

with a fixed-angle plate from May 2008 through May

2009. We included patients with displaced, unstable

proximal fractures of the humerus, provided the humeral

head was not stripped of soft-tissue attachments and was

technically reconstructable. Patients were included

independently of the fracture type if they had a mature

skeleton and if there had been a delay between accident

and surgery of not more than 10 days. Patients with open

fractures or concomitant fractures of the ipsilateral distal

humerus or elbow were not included. Also excluded

were patients with allergic reactions against TachoSil®

constituents, pregnant or lactating women, severe neuro-

logic or psychiatric disorders, missing compliance and

participation in other clinical trials.

8 men and 32 women with a median age of 74.15

(44.6-88.6) years were included.

Mean weight was 65 Kg (53-98). Mean height was

166 cm (149-174). Mean body mass index was calculated

24.32 (19.49-33.13). All patientes were devided in two

groups: Group I with plate osteosynthesis without

TachoSil®, Group II with plate osteosynthesis with

TachoSil®. Every second patient was included in group

II.

Standard radiographs in two planes (AP and axial)

were obtained for all patients and were used to plan the

surgical procedure. CT-scan was reserved for special

cases. Fractures were categorized with reference to the

Neer classification [14]. In the Neer classification, there

were 3 2-segment fractures, 15 3-segment fractures, and

22 4-segment fractures. The implanted devices were 40

fixed-angle implants “Philos plates” (Synthes GmbH,

Solothurn, Switzerland).

2.1. Surgical Technique

The patient was placed in beach-chair position on a

radiolucent table with side placement of an image

intensifier that would allow viewing of the humeral head

in two planes. The approach was an anterior deltoid split.

Fracture reduction was achieved through indirect

manoeuvres and/or with the help of an elevatorium or

K-wires used as joysticks for reduction of the shaft-head

displacement, and with sharp bone hooks for reduction of

the tuberosities. When anatomical reduction was obtained,

insertion of the screws was performed. Additional tension

band wiring was required in one case. After osteosynthe-

sis one subfascial and one subcutaneous drain was

applicated, in group II a TachoSil® sponge was applicat-

ed on the plate additionally. Postoperatively, the shoulder

was immobilized in a sling for 7-10 days followed by

active movement up to 90° abduction and free flexion and

retroversion for 4 weeks after surgery; then free, active

mobilization was allowed. Duration of operation, peri-

operative and early postoperative complications such as

hematoma and infection and blood loss collected in the

drains were recorded as well. Blood loss collected in the

drains was documented after 30 minutes (M 30), 60

minutes (M 60), 1 day (T01), 2 days (T02) and 3 days

(T03) after the operation. The drains were removed on the

third day.

For statistical analysis Chi2-Test and U-Test were used.

The level of significance was set at p ≤ 0.05.

3. RESULTS

There were 4 peri-operative complications in group II

and one complication in group I (Chi2-Test: p = 0.233).

In group II one hardware failure occurred due to osteo-

porosis requiring revision and reosteosynthesis. Another

patient suffered from paralysis of the radial nerve on day

2 after the operation and recovered uneventfully. One

superficial postoperative infection and one superficial

hematoma required revision surgery, too.

In this group no subfascial hematoma developed. One

subfascial hematoma which required no revision oc-

curred in group I.

Blood transfusion was required 2 times in group I and

3 times in group II (Chi2-Test: p = 0.549).

Duration of the operation was 78.95 ± 42.61 minutes

in group I and 72.63 ± 20.93 minutes in group II (U-Test:

p = 0.930).

Table 1 shows the documented blood loss in the

drains. In sum in group II there was a significant lower

blood loss for the subfascial drain, the region where Ta-

choSil® was applied. (Figure 1) For the subcutaneous

drains there was an obvious but not significant higher

blood loss in group II. No adverse affects related to Ta-

choSil® could be detected.

S. Doleschal et al. / Health 2 (2010) 1421-1424

1423

Table 1. Cummulated blood loss (: statistical significant).

Group II Group I U-Test

with TachoSil without TachoSil

N Mean SD N Mean SD p

M30 RD: subfascial cum 20 7.75 13.23 20 29.15 37.85 0.019 

M60 RD: subfascial cum 20 16.00 23.49 20 49.65 63.27 0.022 

T01 RD: subfascial cum 20 67.85 42.83 20 106.90 80.37 0.083

T02 RD: subfascial cum 20 103.45 51.97 20 139.15 88.29 0.222

T03 RD: subfascial cum 20 144.45 70.53 20 155.90 89.40 0.850

M30 RD: subcutan. cum 20 15.10 44.75 20 6.00 16.75 0.319

M60 RD: subcutan. cum 20 21.25 52.01 20 13.75 34.10 0.663

T01 RD: subcutan. cum 20 49.60 70.75 20 38.25 59.98 0.460

T02 RD: subcutan. cum 20 71.10 74.48 20 46.00 63.20 0.071

T03 RD: subcutan. cum 20 71.10 74.48 20 49.00 63.32 0.139

Redon Drains: Blood Vol ume

100

120

140

160

180

200

30 m inutes 60 m inutes Day 1 Day 2 Day 3

ml (Mean)

s ubf as c ial G r oup IIs ubfas c ia l Gr ooup I

s ubcutaneous Gr oup I Is ubc utaneou s Gr oup I

Figure 1. Cummulated blood loss collected in the drains.

4. DISCUSSION

The literature describes many options for treatment of

displaced proximal humerus fractures. Treatment focuses

on the displaced fracture fragments, since these may

have limited vascularity and may benefit from reduction

and fixation [4]. Locking plates with a preconfigured

shape and screw direction, which may reduce hardware

complications are well established [1-6]. Postoperative

complications include pseudarthrosis, AVN, loss of cor-

rection, lesion of the radial nerve, superficial postoperative

infections (8-10.3%) [1,7] and hematoma formation

(4.6%) requiring revision surgery [1]. In our study Ta-

choSil® was used to provide fibrinogen and thrombin

locally at the site of bleeding. Upon contact with fluid

the clotting factors of TachoSil® dissolve and form a

fibrin network, which glues the collagen sponge to the

wound surface. Combining the clotting factors in a col-

lagen patch provides a high concentration of clotting

factors at the site where it is specifically needed [9]. In

our study we could detect a significant lower blood loss

of the subfascial drains 30 and 60 minutes after wound

closure, which proves the effectiveness of TachoSil®.

There were no statistical significant differences of blood

loss of the subfascial and subcutaneous drains in the

further follow- up.

There were 4 peri-operative complications in group II

and one complication in group I (Chi2-Test: p = 0.233).

In the TachoSil® group (group II) one hardware failure

occurred due to osteoporosis requiring revision and

re-osteosynthesis. Another patient suffered from paralysis

of the radial nerve on day 2 after the operation and re-

covered uneventfully. One superficial postoperative in-

fection and one superficial hematoma required revision

surgery, too. The above mentioned complications are not

related to TachoSil®. In group I (without TachoSil®) one

subfascial hematoma occurred, which required no revi-

sion. Blood transfusion was required 2 times in group I

and 3 times in group II (Chi2-Test: p = 0.549).

This study has one major limitation. In our prospec-

tive feasibility study only a small cohort of patients was

included. In that way we can state that there is an ob-

vious benefit in surgical treatment of proximal humerus

fractures using TachoSil® in respect to blood loss in the

region of the applied sponge (here: subfascial region).

Therefore further studies with a larger sample size are

required to confirm the efficacy of TachoSil®. Only a

larger study group may explain the obvious higher blood

loss of the subcutaneous drains which could be shown in

the current study.

5. CONCLUSION

TachoSil was found to be safe and effective for

reduction of postoperative bleeding following operative

treatment of proximal humerus fractures. Further studies

with larger sample size are required to confirm the

S. Doleschal et al. / Health 2 (2010) 1421-1424

1424

efficacy of TachoSil® in orthopedic surgery.

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