One year experience of swine dermal non-crosslinked collagen prostheses for abdominal wall repairs in elective and emergency surgery
Montori et al. World Journal of Emergency Surgery
One year experience of swine dermal non- crosslinked collagen prostheses for abdominal wall repairs in elective and emergency surgery
Giulia Montori 1
Federico Coccolini 1
Roberto Manfredi 1
Marco Ceresoli 1
Luca Campanati 1
Stefano Magnone 1
Michele Pisano 1
Elia Poiasina 1
Gabriela Nita 1
Fausto Catena 0
Luca Ansaloni 1
0 General surgery department, Ospedale Maggiore , Parma , Italy
1 Unit of General and Emergency Surgery, Papa Giovanni XXIII Hospital , P.zza OMS 1, 24128 Bergamo , Italy
Introduction: The approach to the abdominal wall surgical repair is dramatically changed in the last years. This study evaluates our institutional outcomes about the usage of biological meshes for abdominal wall repair in different setting: in elective surgery, in emergency surgery and in abdominal wall repair following open abdomen (OA) procedure. Methods: A database was prospectively conducted (January-December 2014) and data were reviewed for patients who underwent to an abdominal wall reconstruction with swine dermal non-cross linked collagens prostheses either in elective or emergency setting, and following OA/laparostomy procedure. Demographic data, co-morbidities, indications for surgery, intra-operative details, post-operative complications and outcome (peri-operative, 3, 6, 9-months) were analyzed. Results: A total of 30 cases were reported: 9 in elective surgery (Group 1), 4 in emergency surgery (Group 2) and 17 with abdominal wall closure following OA management (Group 3). Two meshes were removed: 1 in the Group 1 and 1 in the Group 3. During follow-up only one patient in the Group 3 had a recurrence of the incisional hernia. Mortality rate was 11.1 % at 3 months in Group 1, 0 % in the Group 2, and 29.4 % in peri-operative period in the Group 3. Conclusions: The use of non-cross linked biological meshes can be safe and versatile in different situations from elective to emergency surgery, and also for the reconstruction of the abdominal wall after OA procedure, with an acceptable recurrence and mortality rate.
Biological mesh; Ventral hernia; Abdominal wall repair; Swine dermal collagen; Open abdomen; Laparostomy; Emergency surgery
Abdominal wall hernia is one of the most common
conditions encountered by general surgeons. Procedures to
repair abdominal wall defects are more than 990.000
each year in USA, with an estimated 567.000 of them
performed in emergency [1, 2]. Similar data are reported
in other Western countries . In most cases emergency
hernia repair are performed in adults over 65 years old
. These age-related increasing rates of emergency
hernia repair are associated with increased morbidity and
1Unit of General and Emergency Surgery, Papa Giovanni XXIII Hospital, P.zza
OMS 1, 24128 Bergamo, Italy
Full list of author information is available at the end of the article
mortality risks . In these particular situations the use
of biological materials can be safer than synthetic
meshes . Actually in the late 1990s, biologic materials
for hernia repair were introduced as a possible
biocompatible material to support “in vivo” tissue regeneration
to restore the physiological function of the abdominal
wall [4, 5]. Although these biomaterials enacted a new
conceptual approach in abdominal wall reconstruction
[5, 6], the main reported problems related with the use
of biological meshes are: wound infections, seromas,
fistula formation, recurrence of the defect (25–28 %
in grade 3–4 of the Ventral Hernia Working Group
(VHWG) classification ) and costs [7, 8]. Nevertheless
definitive conclusions about the use of these biological
materials are difficult to drawn due to: lack of adequate
follow-up, use either of different surgical techniques
and/or different types of biological meshes and absence
of high levels of evidence studies [7, 8]. However there
are many advantages in using biological meshes
compared to the synthetic prostheses: less prosthetic
erosions and/or fistulization, less chronic pain, and minor
risk of infection .
Porcine dermal prostheses are manufactured by
collagenic tissue harvesting, followed by a variety of
patented chemical treatments and delipidation processes
. Although natural cross-links exist in native
collagen and function to stabilize the structure of the
collagenic proteins, giving mechanical strength and protection
from collagenase , however some prostheses undergo
to an additional phase chemical cross-linking process
to increase the collagen strength . The addition
of chemical cross-linking between the collagen chains
seems to further reduce the bacterial and host
collagenase enzymes activity, slowing the degradation process
of the prostheses. For this reason the indications report
in literature suggest a use of cross-linked mesh in more
contaminated field . However some authors reports
that porcine biologic non-cross-linked mesh has been
used to support the repair of abdomen wall with a
hernia recurrence rates of 7 % in case of underlay position,
while in the cross-linked porcine mesh group infection
and explantation rates were relatively higher . These
data indicate that there is currently no ideal biologic
mesh for complex hernia repair and the candidate for
biologic mesh implantation has not been clearly defined
yet. A Randomized Control Trial (SIMBIOSE study: use
of biological mesh versus standard wound care in
infected incisional ventral hernias) is ongoing to evaluate
the efficacy of biologic mesh in infected field .
This study evaluates our institutional outcomes about
the usage of biological meshes for abdominal wall repair
in three different setting: in elective surgery, in emergency
surgery and following open abdomen (OA)/laparostomy
An analysis was performed on a prospectively
maintained database from January 1st, 2014 to December 31st,
2014 of all patients who underwent primary or recurrent
hernia repair with the usage of swine dermal collagens
prostheses at Papa Giovanni XXIII Hospital (Bergamo,
Italy). Enclosed patients were divided into 3 groups:
abdominal wall reconstruction in elective surgery (Group 1),
in emergency surgery (Group 2) and following OA/
laparostomy management (Group 3). In all patients were
used 1.4 mm thick, non-cross linked swine dermal
collagen prostheses, with different dimensions (8*14, 10*20,
25*18, 20*30) (Protexa™, Tecnoss, Giaveno, Italy), fixed to
the fascia with resorbable PDS 1 or 0. In case of elective
surgery and in clean field the antibiotic prophylaxis used
was Cefazolin 2 g, in the dirty and contaminated field the
antibiotic theraphy was accord to the WSES guideline for
the management of the intra-abdominal infection (IAI)
. Patients data were collected and analyzed evaluating
demographic characteristics, co-morbidities, surgical
indications, intra-operative details, complications (according
to the Dindo-Clavien classification ) and outcome
(peri-operative, at 3, 6, 9 months). Incisional hernia was
classified according to the VHWG classification . In
case of septic implant, the peritonitis severity was
evaluated according to the Mannheim Peritonitis Index (MPI) at
the first laparotomy and at every subsequent abdominal
exploration if indicated . The severity of the trauma
was calculated according to the Injury Severity Score (ISS)
. Balthazar score was used to evaluate the severity of
pancreatitis . The OA was classified according to the
Björck classification .
Thirty patients undergoing abdominal wall
reconstruction with indication for biologic mesh placement and
with swine dermal non-crosslinked collagen prostheses
implant were enrolled in the study period. Of these
patients, 9 were in Group 1 (Table 1), 4 in Group 2
(Table 2), and 17 in Group 3 (Table 3). According to the
Hernia Grading System  5 of the 30 patients presents
a clean surgical site but high comorbidities, 21 patients
have a contaminated field, and four patients have a dirty
In Group 1, nine patients were enrolled: four of them
were female. The mean age was 68.3 years (range 53–83).
In all patients the surgical indication was incisional hernia
repair. The use of the biological mesh was imposed due to
the co-morbidities of the patients (grade 2 VHWG
classification) and due to the presence of a previous wound
infection and/or gastrointestinal tract resection (grade 3
VHWG classification). In six patients one or more
comorbidities were present and listed as follows:
immunodepression, a concomitant malignancy, abdominal aortic
aneurism, diabetes, cardiopathy, bronchopneumopathy
chronic obstructive. The others 3 patients have no
comorbidity. However all these nine patients presented an
intraoperative condition requiring the placement of a biological
prosthesis: six patients underwent to colic anastomosis for
colic resection, one patient had a prosthetic infection, and
two patients had intra-abdominal infections (abscess from
acute appendicitis and a ischemic small bowel).
In Group 2, four patients were enclosed (2 were
female), with a mean age of 76.5 years (range 66–89). In
this group the surgical indications were the following:
Previous prosthetic infection 1 (11.1)
Abdominal aortic aneurism
Complicated incisional hernia
Diverticular perforation and
Eventration and ileo anastomosis
Recto-vaginal fistula and
Inflammatory bowel disease
Median (range), dys
Table 1 Patients characteristics underwent to abdominal wall
repair in elective surgery
Table 2 Patients characteristics underwent to abdominal wall
repair in emergency surgery
(SD standard deviation; pts patients, yrs years, BPCO bronchopneumopathy
aMore than one patient has more than one comorbidity
abdominal hernia complicated with an enterocutaneous
fistula, a diverticular perforation with a large incisional
hernia, an eventration complicating a previous surgery
with a small bowel resection and anastomoses, and an
incisional hernia with a recto-vaginal fistula in Crohn
disease. Two patients presented more than one
comorbidity: corticosteroid therapy, cardio-vascular disease,
inflammatory bowel disease, and cerebrovascular disease.
The other two patients had no previous diseases.
In Group 3, 17 patients were analyzed (9 patients were
female). The mean age was 62.6 years (range 18–79). The
main frequent comorbidities were: presence of
cardiopathy and vasculopathy, the malignancy (gastric and colic
cancer), and an immunosuppressed status. The others
comorbidities present were the following: abdominal aortic
aneurism, hemodialysis, and diabetes. Only three patients
had no comorbidity. Seven patients (41.2 %) underwent to
(SD standard deviation, pts patients, dys days, yrs years)
aMore than one patient has more than one comorbidity
an OA procedure for intra-abdominal sepsis
(anastomotic leak, appendicular peritonitis, biliary peritonitis),
four patients (23.6 %) for intestinal ischemia, three
patients (17.6 %) for trauma, two patients (11.8 %) after
vascular surgery complications (duodenal perforation
after exclusion of aortic aneurism), one patient (5.8 %)
for severe acute pancreatitis. In 12 patients (70.6 %) the
choice for the OA was to prevent the abdominal
compartment syndrome; in 5 cases (29.4 %) the OA was
performed to treat an increase of intra-abdominal
pressure. In all patients the abdominal closure was planned
at the first laparotomy and the decision of the
biological prostheses usage was related to the
intraoperative condition at the moment of the abdominal
wall reconstruction. Eight patients (47 %) were from
the Intensive Care Unit (ICU). For the three trauma
patients the mean and median ISS were 38.3 (SD ± 14.3)
Table 3 Patients characteristics underwent to abdominal wall
Comorbiditiesa Corticosteroid therapy 2
Table 3 Patients characteristics underwent to abdominal wall
repair in open abdomen (Continued)
Causes of OA Prevention of ACS 12 (70.6)
Treatment of ACS 5 (29.4)
Type of OA NPWT 16 (94.2)
Skin closure 1 (5.8)
Closure abdominal Mean (SD), dys 6.1 (±3.5)
wall Median (range), dys 6 (1–15)
Stoma Yes 4 (23.5)
- colostomy 2 (50)
- ileostomy 1 (25)
- urostomy 1 (25)
No 13 (76.5)
Intestinal anastomosis Yes 11 (64.7)
No 6 (35.3)
Enterocutaneous Yes 1 (5.8)
fistula No 16 (94.2)
Fascia closure Yes 9 (53)
No 8 (47)
Prothetic position Onlay 2 (11.8)
Inlay 1 (5.8)
Retromuscolar 9 (52.8)
Preperitoneal 0 (0)
Intraperitoneal 5 (29.6)
Hospital stay ICU
Mean (SD), dys 23.9 (±18.2)
Median (range), dys 20 (2–71)
Mean (SD), dys 28.4 (±21.2)
Median (range), dys 23 (0–70)
Mortality rates Peri-operative 5 (29.4)
At 3 months 0 (0)
At 6 months 0 (0)
At 9 months 0 (0)
(NPWT negative pressure wound therapy, pts patients, dys days, yrs years,
SD standard deviation, ISS Injury Severity Score, MPI Mannheim Peritoneal
Index, OA Open Abdomen)
aMore than one patient has more than one comorbidity
and 35 (range 26–54) respectively. For the patient with
pancreatitis the Balthazar score before surgery was E.
In Group 1, the mesh was placed intra-peritoneally in three
patients and in the retromuscolar plane in six patients.
In Group 2, the mesh was placed inlay (as a bridge
between the medial edges) and onlay (in the subcutaneous
space) in one patient each, and in the retromuscolar
plane in two patients.
In Group 3, in 14 patients (the three trauma patients
were excluded) the mean MPI was 26.6 (range 15–43).
Four patients had a MPI < 21, five patients had a MPI
between 21 to 29 and five patients had a MPI up to 29.
According to the Björck score the majority of the
patients (7 patients) had a grade Ia at the first laparotomy.
Four patients had a grade Ib, and six patients had a
grade IIb. At the closure, the rate of grade Björck Ia was
in 13 patients (3 patients had a Björck IIa, and 1 patient
a Björck IV). In 16 patients the OA was managed with a
negative pressure wound therapy (NPWT) technique,
and in 1 case the skin closure technique was performed.
At the definitive intervention, the fascial closure was
performed in nine patients (53 %), in the others eight
patients only the posterior fascia was closed. In all 17
patients the abdominal wall was reinforced with a
biological mesh: in nine patients the mesh was placed in
the retromuscolar plane (sublay), in five patients
intraperitoneally, in two patients onlay, and in 1 pt it was
placed inlay. The time to definitive abdominal closure
after OA was 6.1 days, with a range of 1–15. In four
patients (25 %) a stoma was performed, meanwhile 11
patients (70.6 %) had an intestinal resection and
anastomoses during the abdomen revision.
In two patients the mesh was removed: in the first case
(Group 1) because the patient was re-operated for an
intestinal ischemia, in the other patient (Group 3) for a
duodenal fistula. In the last case the patient was left
open and the wound was treated with a Vacuum
Assisted Therapy (VAC).
In Group 1 the mean hospital stay was 21 days (range
7–70). The follow up at 3-months was completed for 9
patients: 2 patients has a grade I complication (wound
infection), 1 patient had a grade IVb (re-operated for a small
bowel ischemia), 1 patient died for a septic shock in a
leucopenia, 4 patients were free from complications. One
patient was lost at the follow-up. Four patients completed
the follow-up at 6 months: 3 patients were free from
complications, one patient died for a septic shock in leucopenia
for the important lymphoproliferative disorder associated
with recent chemotherapy regimen. One patient was lost at
the follow-up. No patients completed the 9-months
followup. One patient (11.1 %) died (septic shock in leucopenia).
In Group 2 the mean hospital stay was 21.5 days
(range 7–45). One patient presented a grade I
complication (wound infections), one patient presented a grade II
complication (wound dehiscence) requires a
vacuumassisted closure technique. Two patients had no
complications. One patient was lost to follow-up. The overall
mortality was 0 %.
In the Group 3 the mean and median ICU stay was
23.9 days (range 2–71), and the mean ward stay was
28.4 days (range 0–70). In peri-operative time: 4 patients
presented a grade I complication (wound infection), 1
patient presented a IIIb complications (a duodenal
fistula due to a dehiscence of the duodenal perforation that
required another surgical intervention and a VAC
therapy to manage the fistula) and the patient is still
hospitalized. Seven patients were free from complications. Five
patients died (2 for aortic rupture, 2 for septic shock, and
1 for respiratory insufficiency and septic shock). Twelve
patients completed the follow-up at 3 months: 1 patient
presented a Grade II complication (incisional hernia non
complicated), 1 patient require the pursuit of the VAC
therapy to manage the duodenal fistula. Seven patients are
free of complications. Three patients were lost to
followup. No patients died at 3 months follow-up. Six patients
completed the follow-up at 6 months: 1 patient presented
a Grade II complication (incisional hernia non
complicated). Two patients were healthy. Three patients were
lost to follow-up. No patients died at 6 months follow-up.
Two patients completed the follow-up at 9 months: 1
patient had no complications. One patient was lost to
follow-up. No patients died at 9 months follow-up. The
overall peri-operative mortality was 29.4 % (5 patients).
Incisional hernia remains a common complication in
abdominal surgery and occurs after elective laparotomy
with an incidence from 2 to 20 % or more [7, 19, 20].
However, these rates can increase (as high as 50 %) after
abdominal closure in emergency surgery and in the
abdominal repair following OA procedure [21–23]. The
approach to the abdominal wall surgical repair is
dramatically changed in the last years due to the availability
of new repair materials, like biologic prostheses.
Although in last years many studies tried to find an
agreement about specific technique and materials that should
be applied to repair of complex ventral hernia, at present,
no strong consensus has been found yet [4, 24]. However
the use of biologic prostheses is actually accepted by the
medical community for addressing abdominal wall defects,
particularly in contaminated and potentially contaminated
fields [11, 25]. Despite this, the numerous advantages of
biologic materials have been proven [11, 26, 27].
The present study reports a one-year experience about
the usage of biological prostheses in different fields from
elective surgery to emergency surgery and OA
procedure. We analyze our surgical indications to the usage
of biological meshes to evaluate the outcomes and the
feasibility in these fields.
In the first group we considered only the patients
underwent to ventral hernia repair in elective surgery. In
all patients the abdominal wall defect was associated
with high risk of contamination or an already existing
infection imposed the positioning of a biological prostheses.
The decision of the positioning of the prosthesis was
based on the VHWG and the Italian Biological Prostheses
work-group recommendations [4, 11], according to the
degree of contamination potential or effective, and
according to co-morbidities of the patient. In literature also
others studies confirmed and supported these
recommendations [7, 28, 29]. In our study, more than half of the
patients of this group had more than one comorbidity (in
particular immunosuppression and malignancy), that
associated with a local wound infection or intra-abdominal
infection have prevented the use of a synthetic mesh. In
two third of patients the mesh was placed in the
retromuscolar space, in line with the literature [9, 30]. The
“sublay” position (posterior to the rectus muscle) has been
the most used, in fact it allows for better tissue
incorporation and lower chance of bacterial contamination,
increases neo-angiogenesis and avoids the direct contact
with intra-abdominal viscera [1, 9]. In this group only one
patient died at three months for a septic shock, and in one
case we had to remove the mesh because the patient was
re-operated for an intestinal ischemia.
At the analysis of the second group (patients
underwent to ventral hernia repair in emergency conditions)
we found that the presence of wound infection or
intraabdominal infection are the main indication requiring a
biological mesh positioning. This decision was also
dictated by the important comorbidities present in half of
patients. The other important point has been the age of
patients (older than patients in others group, with a
median age of 75.5 years). In last year the number of elderly
patients (>65 years) underwent to ventral hernia repair
in emergency setting is increasing . A recent study
reports that the risk of operative factors associated with
the risk of surgical site infection were open procedures,
incisional/ventral repairs, and hernia repairs with bowel
obstruction/necrosis . Into account of these data and
according to the VHWG recommendations  we
decided to repair the abdominal wall defect with a
biological mesh, with favorable outcomes and with an
acceptable hospital stay (median 16.5 days).
The third group was the largest group. The problem
of abdomen closure after OA procedure remains the
most critical point for these patients [21–23]. Data about
long-terms outcome after repair of abdominal wall in
OA procedure are still lacking and the durability of the
different biologic meshes has not been clinically proved
[26, 31]. Our surgical indications for an OA procedure
requiring a biological prostheses positioning were the
difficulty to close the abdominal wall (the anterior and
the posterior fascia) or to reinforce the closure of the
posterior fascia (when the anterior fascia was impossible
to close). The main causes for a laparostomy were
secondary peritonitis, intestinal ischemia and trauma. The
conditions that required leaving the abdomen open
remains the abdominal compartment syndrome (ACS)
or the conditions that promote an intra-abdominal
hypertension (IAH) (intestinal ischemia, acute severe
pancreatitis, vascular complications), or in case of
damage control surgery (trauma) [13, 26, 32–34]. Recently
the approach to the intra-abdominal sepsis was changed
and leaving the abdomen open in that condition has
been proven to reduce mortality and post-operative
complications [31, 35]. The primary goal remains the
source control and a temporary abdominal closure was
considered a valid instrument to manage severe
abdominal sepsis . In our series the traumatized patients
undergone to OA had severe trauma (ISS > 25). In the
two-third of cases we have proceed to OA management
to prevent an ACS; in only one-third OA procedure was
considered as treatment of the IAH or of the ACS. In
patients with intra-abdominal sepsis the scoring system
to estimate the severity and prognosis of secondary
peritonitis we used was the MPI . Literature reports that
a MPI greater that 29 relates with high mortality rates
(100 % vs 0–2.3 % in patients with MPI < 21) . In
our series one–third of patients have severe peritonitis
(MPI > of 29), and these MPI values associated with the
important comorbidities may be the responsible for the
high peri-operative mortality rate (29.4 % at our
analysis). In the present series the status of the OA has been
evaluated at the first laparotomy and at the last one
according to the Björck classification . Data reported
an increased number of patients presenting a Grade 1A
(clean OA without adherence between bowel and
abdominal wall or fixity) at the abdomen closure (from
41.4 %, at the first laparotomy, to 76.6 %, at the last
laparotomy). These results showed the efficacy of the
OA treatment in reducing the intra-abdominal
contamination. Regarding to the technique used for temporary
abdominal closure we used the NPWT in almost all
cases. This strategy seems to be the best in preventing
evisceration, actively remove any infected or toxic fluid
from the peritoneal cavity, prevent the formation of
entero-atmospheric fistulas, preserve the fascia and the
abdominal wall domain, make reoperation easy and safe,
and achieve early definitive closure [23, 26, 36]. Our
goals were to close the abdomen wall as soon as possible
(within 5–7 days) [26, 27, 37] to reduce the OA
complications. A recent prospective controlled trial and a
systematic review suggested that use of a dynamic fascial
sutures combined with NPWT in the treatment of OA
for intra-abdominal sepsis is safe and associated to a low
rate of incisional hernias and entero-atmospheric fistula
[22, 23]. However in our series almost all patients
despite the NPWT alone, the closure of the abdominal wall
happened in an average of 6.1 days, but in 53 % of cases
the fascia was closed with a mesh in the retromuscolar
space [9, 30]. The main complications after OA remain
the enterocutenaous fistula and the long-term ventral
hernia, in addition to the high rate of morbidity and
mortality associated with the procedure [8, 26, 38]. A
recent meta-analysis about OA and temporary abdominal
closure techniques in non-trauma patients (4358
patients) reported a mortality rate near to 30 %, with an
overall rate of fistula of 12.1 %, with a 14.6 % in series
applying NPWT without fascial traction, and of 5.7 %
after NPTW with fascial traction . Others studies
reported a high delayed facial closure rate ranging from
34 % and 73.6 % in septic patients, with lower rates in
trauma patients due to the more frequent early
abdominal closure . In our study only one patient had a
duodenal fistula and required the removal of the
prostheses (being managed with a VAC therapy to control
the spillage of duodenal contents ) and only one
patient presented an incisional hernia without
complications. These low rates of incisional hernia are probably
due to the lack of a long-term follow-up. The other
complications in present study were related wound
infection or dehiscence that were managed with local
wound dressing. Also in our data the rate of
perioperative mortality remains high (29.4 %), similar with
the data find in the literature (30 %), however this is
probably due to the extremely compromised conditions
of the patients and the paucity of cases [2, 38].
Despite the limitations present study showed that the
use of non-cross-linked porcine dermal meshes in
different surgical setting, particularly in elderly and septic
patients is safe and effective, without worsening
morbidity and mortality.
The present one-year prospective analysis shows that the
use of swine dermal non cross-linked collagen
prostheses for abdominal wall repair is safe and effective in
general and emergency surgery, particularly in elderly
and in immune-compromised patients. However more
data are necessary. For this reason the development of
big prospective studies are mandatory.
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