Nieuwenhuizen et al.

BMC Surgery 2013, 13:48

http://www.biomedcentral.com/1471-2482/13/48

STUDY PROTOCOL

Open Access

A double blind randomized controlled trial

comparing primary suture closure with mesh
augmented closure to reduce incisional hernia
incidence
Jeroen Nieuwenhuizen1, Hasan H Eker2, Lucas Timmermans2*, Wim CJ Hop3, Gert-Jan Kleinrensink4,
Johannes Jeekel4, Johan F Lange2 and PRIMA Trialist Group

Abstract
Background: Incisional hernia is the most frequently seen long term complication after laparotomy causing much
morbidity and even mortality. The overall incidence remains 11-20%, despite studies attempting to optimize closing
techniques. Two patient groups, patients with abdominal aortic aneurysm and obese patients, have a risk for
incisional hernia after laparotomy of more than 30%. These patients might benefit from mesh augmented midline
closure as a means to reduce incisional hernia incidence.
Methods/design: The PRImary Mesh Closure of Abdominal Midline Wound (PRIMA) trial is a double-blinded
international multicenter randomized controlled trial comparing running slowly absorbable suture closure with the
same closure augmented with a sublay or onlay mesh. Primary endpoint will be incisional hernia incidence 2 years
postoperatively. Secondary outcomes will be postoperative complications, pain, quality of life and cost effectiveness.
A total of 460 patients will be included in three arms of the study and randomized between running suture closure,
onlay mesh closure or sublay mesh closure. Follow-up will be at 1, 3, 12 and 24 months with ultrasound imaging
performed at 6 and 24 months to objectify the presence of incisional hernia. Patients, investigators and radiologists
will be blinded throughout the whole follow up.
Disccusion: The use of prosthetic mesh has proven effective and safe in incisional hernia surgery however its use
in a prophylactic manner has yet to be properly investigated. The PRIMA trial will provide level 1b evidence
whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups.
Trial registration: Clinical trial.gov NCT00761475.

Background
Incisional hernia (IH) is the most frequently seen long term
complication in surgery causing much morbidity and even
mortality in patients [1-4]. Despite studies on the optimal
closing technique for laparotomies, the risk for IH after
midline incision remains about 11-20% [5,6]. In the
Netherlands alone about 4000 IH operations are performed each year. Incisional hernia surgery is, in fact, a
re-operation to relieve symptoms caused by this common complication and the results of repair are often
disappointing [7,8].
* Correspondence: l.timmermans@erasmusmc.nl
2
Department of Surgery, Erasmus MC, Rotterdam, The Netherlands
Full list of author information is available at the end of the article

Patient-related risk factors for incisional hernia after a

laparotomy, like obesity, steroid use, malnutrition, smoking,
abdominal aortic aneurysm (AAA), and connective tissue
disorders are known [7,9-13]. Despite this knowledge a
sufficient method for prevention, has not been developed
yet. Most research in the field of incisional hernia surgery
has been performed to prevent recurrence after repair.
The closure technique of midline incisions has grosso
modo remained unchanged since many decades and primarily consists of suturing the linea alba. Interest in prevention of incisional hernias with the aid of synthetic
mesh is growing and small, yet promising studies have
now been published [14-25].

2013 Nieuwenhuizen et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the
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distribution, and reproduction in any medium, provided the original work is properly cited.

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One specific group of high-risk patients are patients

with an AAA. Aortic aneurysm is considered to be related
to a type of connective tissue disorder. The connective
tissue in these patients is thought to be compromised,
playing an important role in the pathogenesis of an
aneurysmal distension of the aorta. Healing of the midline
fascia after laparotomy may be compromised due to formation of collagen with insufficient strength. Sutures can
tear through the fascia and defects can develop in the abdominal wall. The relationship between aortic aneurysm
and other abdominal wall hernias, like inguinal hernias,
has been reported [26-28]. Retrospective and prospective
studies have shown an average risk for incisional hernia
after AAA repair of about 30% (Table 1) [9,26,28-34].
Another high risk group is the group of obese patients
[5]. Patients with a BMI of 30 or more have a high risk of
developing an incisional hernia after midline incision, with
an incidence of 22% after 12 months [5,13]. Most recent literature is showing us that even a BMI of more than 27
gives a 20% risk for developing an incisional hernia after
midline laparotomy [35]. Considering only 50% of incisional
hernia will be clinically evident in the first 12 months, the
total incidence is likely to be above 30%. It is known from
the study of Burger et al. that an extensive follow up time
of up to 10 years is needed to evaluate outcome in hernia
surgery [7]. A tailored approach might be necessary,
since hernia formation is multifactorial. Thus, the above
mentioned high-risk group of patients with obesity and
aneurysmal disease can benefit most from prevention.
Some small studies have been performed to evaluate
the effect and safety of primary laparotomy wound closure with the aid of prosthetic mesh (Table 2) [14-25].
These studies show a very low risk for incisional hernia
and a low infection rate, even when used in contaminated areas, as seen in colostomy surgery. However, no
high quality and adequately powered randomized controlled trial has been performed to evaluate the impact
of prophylactic mesh augmentation for prevention of

incisional hernia in high risk patients. This is the reason

that the PRImary Mesh Closure of Abdominal Midline
Wound (PRIMA) trial is being conducted.
Objective

The objective of this study is to evaluate the effectiveness

of incisional hernia prevention in patients after laparotomy for aortic aneurysm and in obese patients with a BMI
of more than 27. A double blind randomized controlled
trial will compare the commonly used technique of running suture to closure with the aid of a prosthetic mesh.
 The primary outcome measure will be incisional

hernia occurrence 2 years postoperatively.

 Secondary outcome measures will cover relevant

postoperative complications, post-operative pain and

quality of life.

Methods/design
Trial design

The trial is a double blinded randomized controlled international multi centre trial comparing traditional closure
with running slowly absorbable suture to closure with the
aid of prosthetic mesh. A total of 11 centers have agreed to
participate in the trial which are located in three different
countries (The Netherlands, Germany and Austria). A total
number of 460 patients will be included. Patients will be
randomized in three groups per-operatively to either receive primary closure, or mesh supported closure either in
a sublay or onlay position. Patients will be kept unaware of
the procedure until the endpoint of the trial was assessed.
Outpatient clinic controls will be done by surgeons or surgical residents blinded for the procedure. Results will be
stratificated by center and operation indication.
Participants

Patients meeting the inclusion criteria scheduled for

elective laparotomy will be asked to participate in the

Table 1 Publications concerning risk for incisional hernia after aortic aneurysm repair with midline incision with a
minimum of 2 years follow-up
Author

Year

Follow-up

Article type

# Hernias

# AAA

Fassiadis et al. [9]

2005

50 months

RCT

20

22

90,9

Rodriguez et al. [29]

2004

36 months

Prospective

14

61

22,9

Liapis et al. [30]

2004

63 months

Prospective

32

197

16,2

Raffetto et al. [28]

2003

33 months

Prospective

50

177

28,2

Augestad et al. [31]

2002

42 months

Case series

49

140

35

Musella et al. [32]

2001

49 months

Prospective

16

51

31,4

Adye and Luna [26]

1998

36 months

Retrospective

18

58

31,0

Holland et al. [33]

1996

24 months

Case series

13

34

38,2

Stevick et al. [34]

1988

38 months

Retrospective

10

27

37,0

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Table 2 Publications concerning incisional hernia prevention with the aid of prosthetic mesh
Author

Year Type article # Patients Hernia primary Hernia Mesh Follow-up Mesh type

G. Curr et al. [14]

2011 Prospective

95

15/50

2/45

24 months Polypropylene Sublay

Mesh position

O. H. Llaguna et al. [15]

2011 Prospective

134

11/62

1/44

17 months Biological

P. M. Bevis et al. [16]

2010 RCT

85

16/43

5/37

36 months Polypropylene Sublay

Intraperitoneal

G. Curr et al.

2010 Prospective

50

8/25

1/25

12 months Polypropylene Sublay

M. P. Hidalgo et al.

2010 Cohort

72

0/72

46 months Polypropylene Onlay

O. H. El-Khadrawy et al. [19]

2009 RCT

40

1/20

3/20

36 months Polypropylene Preperitonial

G. Hebert et al.

2009 Cohort

16

1/16

6 months

J. Strzelczyk et al. [21]

2006 RCT

74

8/38

0/36

28 months Polypropylene Sublay

J.L. OHare et al. [22]

2007 Cohort

39

1/28

48 months Polypropylene Sublay

Mix

Sublay

C. Gutierrez de la Pena et al. [23] 2003 RCT

88

5/44

0/44

36 months Polypropylene Onlay

J. Strzelczyk et al. [24]

2002 Prospective

60

9/48

0/12

12 months Polypropylene Sublay

A. Pans [25]

1998 RCT

288

41/144

33/144

29 months Vicryl

study. After ample information has been given, patients

will be asked for informed consent.

Intraperitoneal

telephone or using the online inclusion randomization

system. The patient will stay in the randomization group
on an intention to treat principle.

Inclusion criteria
Intervention
 Every elective midline laparotomy for patients with

Abdominal Aortic Aneurysm AND/OR patients

with a BMI of more than 27a.
 Signed informed consent
Exclusion criteria
 Age < 18 years
 Inclusion in other trials with interference of the

primary endpoint
 Life expectancy less than 24 months (as estimated

by the treating physician)

 Pregnant women
 Immune suppression therapy within 2 weeks before

surgery
 Bovine allergy

Registration and randomization procedure

Patients who are scheduled for operation and who have

given informed consent will be registered by contacting
the trial coordinator using the telephone or using the online inclusion randomization system. Included patient are
registrated in an online data base (designed and managed
by HOVON data center, Rotterdam, the Netherlands)
called TOP (Trial Online Process; see http://www.primatrial.nl). The patient name code, date of birth, name of
caller, name of responsible physician, sex and eligible criteria will be registered. Every participating institution has
its own login code.
Randomisation will take place at the end of the scheduled operation before closing the abdomen in the operating room by contacting the trial coordinator using the

Patients will be randomized for three different closing

techniques (1A: primary suture closure of the midline
fascia, 2B onlay mesh supported closure and 3C sublay
mesh supported closure). Both mesh techniques are extensively used in incisional hernia surgery. However, a powered randomized comparison of these two techniques has
not been performed. Infection rates in these trials seem
low, even in the presence of open bowel [36-41]. Because
the study population will not be operated for an incisional
hernia, which necessitates extended dissection of the abdominal wall in a previously operated area, infection rates
are expected to be lower than the rates mentioned in the
literature. Intra-peritoneal placement has not been considered given the high risk for adhesions between viscera and
mesh [42].
The mesh will be fixed to the fascia structures with fibrin
sealant (Tissucol DUO 500 2,0 ml (Baxter Deutschland
GmbH, Unterschlieheim, Germany) in order to avoid sutures subcutaneously, to prevent the production of seroma
and to simplify the procedure [43]. Nowadays fibrin sealants are occasionally used in inguinal hernia surgery
[44-46]. The mesh will be fixed adequately with fibrin
sealant to the ventral part of linea alba and posterior
rectus sheath. The Optilene Mesh LP, 6 35 cm, B.
Braun Aesculap AG, Tuttlingen, Germany, will be used
as it was shown to have an optimal fixation with fibrin
sealant and to provide good tensile strength [47].
Only the first operations of each center will be supervised by one of the PRIMA trial research fellows. If during operation an incisional hernia was discovered the
patient was excluded from the trial, as the interest of
this study was incisional hernia prevention, not repair.

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All centers were familiar with the 4:1 suture length to

wound length ratio concept although not measured. As
the focus of the trial was on the effect of primary mesh
augmentation versus common day practice closure, no
measurements of the suture closure were done.

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running slowly absorbable suture (Monoplus, USP1, Needle

HRT48, 150 cm, B. Braun Aesculap AG, Tuttlingen,
Germany), covering the mesh. A suture length to wound
length ratio of 4:1 was recommended (not measured). Subcutaneous tissue and skin will be closed in a fashion preferred by the surgeon.

Group A. Primary closure of the midline

The midline fascia will be closed in all three groups with a

running slowly absorbable suture (MonoPlus, USP 1, Needle
HRT48, 150 cm loop, B.Braun Aesculap, Tuttlingen,
Germany). The ratio of suture length to wound length of 4:1
is recommended (but not measured). Subcutaneous tissue
and skin are closed in a fashion preferred by the surgeon.
Mesh supported closure
Group B. Onlay mesh supported closure

First, the midline will be closed as indicated in group A.

The Optilene Mesh LP will be positioned on the primary closed midline fascia with an overlap of 3 cm at
each side. The mesh will then be fixed with fibrin sealant
(5 ml). The fibrin sealent will be applied on the entire
surface of the mesh, and in one shot having permanent
contact between the mesh and the tip of the joining
piece. Immediately after application of the fibrin sealant,
the mesh will be smoothed with the back of a forceps to
get a good fixation of the mesh on the entire surface and
especially on the suture line. If present, it is also possible
to use spray fixation using the EASYSPRAY system,
Deutschland GmbH, Unterschlieheim, Germany. When
laparotomy is larger then 25 cm use 2 applicators of Tissucol (10 ml). Subcutaneous tissue and skin are closed
in a fashion preferred by the surgeon.
Group C. Sublay mesh supported closure

A space will be created between both posterior rectus

sheaths and the rectus muscle. Both posterior rectus sheath
edges are sutured using a running slowly absorbable suture,
(Monoplus, USP1, Needle HRT48, 150 cm, B. Braun
Aesculap AG, Tuttlingen, Germany). A suture length to
wound length ratio of 4:1 was recommended (not measured). The Optilene Mesh LP will then be placed between the posterior rectus sheath and the rectus
muscle with an overlap of 3 cm at each side and fixed
with fibrin sealant (5 ml). The fibrin sealent will be applied on the entire surface of the mesh, in one shot
having permanent contact between the mesh and the tip
of the joining piece. Immediately after application of the fibrin sealant, the mesh will be smoothed with the back of a
forceps to get a good fixation of the mesh on the entire surface and especially on the suture line. If present, it is also
possible to use spray fixation using the EASYSPRAY system,
Deutschland GmbH, Unterschlieheim, Germany. When
laparotomy is >25 cm use 2 applicators of Tissucol (10 ml).
The midline anterior rectus sheath will be closed using a

Postoperative treatment:

Wound drainage will not be routinely applied. Seromas

do not have to be punctured or drained, but can be left
untreated to resolve spontaneously.
Implementation
Pre-operative data














Date of birth
Length and weight
Smoking history (current smoker ( Y or N )
Medical history (COPD, diabetes, cardiac disease)
Preoperative Radiotherapy or chemotherapy
Preoperative corticosteroids
Postoperative corticosteroids
Previous abdominal operations
Other abdominal hernias (inguinal, umbilical,
epigastric hernias)
ASA class
Width of linea alba (when pre-operative C.T.
imaging is available)
Size of aneurysm and location
Epidural catheter

Operation data













Type of operation
Type and length of prosthesis
Volume of fibrin sealant applied
Length of incision
Blood loss
Operation time
Antibiotic prophylaxis
Suture material
Drains and location
Thrombosis prophylaxis
Pain medication
Complications (intestinal lesions, bleeding, other)

Post-operative data





Blood transfusion
Postoperative ventilation and duration
Postoperative ileus and duration
Postoperative complications:
Surgical Site Infection, according to the guidelines
proposed by Mangram in 1999 [48]. (Appendix)

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Wound hematoma: accumulation of blood in

the wound area, which warrants surgical
exploration and intervention.
Seroma subcutaneously
Pulmonary infections
Ventilation problems
Re-intervention and difficulties caused by the
mesh at re-entry
Re-admission and indication

hernias, will be calculated. Quality Adjusted Life Years

will be calculated.
An incisional hernia correction costs 3777,-. When
100 patients are operated with the aid of a mesh insertion we estimate to prevent 15 incisional hernias
(=56.655,-). One hundred meshes cost approximately
30.000,-. We would save 26.655,- if all incisional hernias are repaired. We did not include all extra costs as
for example visits to the general practitioner, but these
will be included in our final analysis.

Ultrasound examination

At 6 and 24 months ultrasound imaging will be performed to examine the midline for any asymptomatic
clinically not detectable incisional hernias. This will provide valuable information about the onset of an incisional hernia. Size and location of all incisional hernias
noted radiographically will be registered, as well as complaints presented by the patients. Endpoint of this study
will be at 2 years follow up. At this follow-up the presence of a hernia will be investigated by physical examination and ultrasound imaging.
Outpatient follow-up

The follow-up schedule is displayed in Table 3. During

visits the following information will be gathered.
 Outpatient clinic visit at 1, 3, 12 and 24 months

Incisional hernia
Wound infection
Seroma formation
Other wound problems
Inguinal hernia
 Ultrasound at 6 and 24 months
 VAS score at 1 month
 VAS scores and Quality of Life forms preoperatively
( day of operation or the day before) and at 3, 12
and 24 months
Economical evaluation

Cost effectiveness will be calculated after 2 years. The

direct costs, admissions, operation costs, costs of materials and treatment of complications and incisional

Statistical analysis

Three comparisons will be made leading to pair-wise comparison at alpha = 0.017 (=0.05/3) according to Bonferronis
correction for multiple testing. Assuming a 30% rate of incisional hernia in group A, and about 10% in both groups
B and C, for a power of 90% comparing group A versus
group B and C, 92 patients are required in group A and
164 in groups B and C. Allowing for some dropouts, 100
will be included in the control group and 180 in each experimental group.
It is expected that differences between groups B and C
can only be demonstrated with a very large number.
Therefore it was decided to set the objective to showing
non inferiority for onlay (group C) versus sublay (group
B). Setting the non-inferiority margin at 10%, the power to
show non-inferiority regarding the incidence rate of incisional hernia will be greater than 80%.
For the comparison of both experimental groups with
the control group, Kaplan-Meier curves will be constructed and the log-rank tests will be performed. These
logrank tests will be done with stratification by center
and operation indication.
For the comparison of both experimental groups B
and C, the cumulative 2-years probability will be calculated with the one-sided 98.3% confidence interval for
the difference. Analysis will be done according to the
intention-to-treat principle in comparing group A with
groups B and C. For the comparison of groups B and C
a per-protocol analysis will be the primary analysis.
Comparison of VAS and QOL scales between groups
will be done using Repeated Measures Anova (SAS PROC

Table 3 Follow up schedule

Evaluation moments

MOS SF-36 (1)

EQ-5D (2)

Pre-operative

X
X

3 months

12 months

24 months

1 month

VAS score (3)

Outpatient clinic

Ultrasound

(1) MOS SF-36: Questionnaire concerning quality of life (SF-36 Health Survey, Medical outcomes Trust, Boston, Massachusetts 02116, USA).
(2) EQ-5D: Euro Qol Group quality of life questionnaire.
(3) VAS score: Pain measurement tool on which patients can define their pain on a sliding scale.

X at 6 months

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MIXED) with baseline value, age, gender, operation indication and center as covariates.
The following putative risk factors regarding incisional
hernia (smoking, infection, diabetes, corticosteroids) will
be evaluated using Cox-regression.
Serious Adverse Event (SAE) reporting & Monitoring

A SAE will be reported to the Dutch Department for

Human Research (Centrale Commissie Mensgebonden
Onderzoek), Baxter and Braun within 24 hours.
Requirements for SAE reporting will be:
1. (Prolonged) Hospitalisation (difined as a longer stay
in the hospital than normally expected caused by a
postoperative complication)
2. (Re-)operation
3. Death
Once a year, data from each center will be monitored.
In compliance with GCP guidelines, monitors will verify
data collected on data collection forms against source
documents. Source documents are defined as any original records or data related to the trial or to subject
treatment or medical history. Source documents include:
original hospital, clinical, and office charts, laboratory
notes, subject diaries or evaluation checklists, pharmacy
records, recorded data from automated instruments,
transcriptions (certified to be accurate after verification),
magnetic media, or x-rays.
Ethics

Before centers could participate in this trial, approval

was obtained from the local medical ethics committee
(Medische Ethische Toetsings Commissie, Erasmus MC).
Patients will be extensively informed about the research
project and can only participate after giving informed consent. Patients will always be permitted to withdraw from
the study without providing further reasons. This will have
no consequences for further treatment. Data of these patients will be evaluated in the final analysis. This trial was
registered at Clinical trial.gov under NCT00761475.
History and current status

After Ethical approval was obtained the trial started including patients in the middle of 2009. Initially the intake of patients was rather slow. This was attributed to
the the low number of participating hospitals, the continued increase of laparoscopy and endovascular treatment, and the inclusion criteria of BMI >30. After the
publication of Seiler et al. the BMI inclusion criteria
were lowered from 30 to 27 [35]. The BMI amendment
and the inclusion of additional participating hospitals
made it possible to include more patients per month.
Currently the trial is in the final stage of the inclusion of

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patients. It is estimated that the last patients will be seen

in the outpatient clinic in the beginning of 2015. Around
this time the final results will be subjected to peerreview for publication.

Discussion
Incisional hernia continues to be one of the most frequent
complications after laparotomy. Up to this date no intervention strategy has led to a resolution to this problem. In
high risk patients, with a risk for incisional hernia more
than 30%, an alternative technique with lower incisional
hernia incidence would be highly desirable.
In daily practice almost all midline laparotomies are
closed with slowly absorbable running sutures. This
technique seems ample for low risk patients. Despite the
high incidence of incisional hernia, this technique is still
used in high risk patients. These patients are known to
have altered collagen synthesis in wound repair or increased abdominal wall stress, leading to insufficient repair of the midline after operation.
In incisional hernia surgery the use of prosthetic mesh
has proven its effectiveness and safety. For this reason a
RCT investigating the effectiveness and safety of augmenting the closure of the midline with prosthetic mesh
in high risk patients is being conducted. A high level of
evidence will be obtained due to the design of the study,
as it was a randomized, double blind, powered, multicenter study.
Conclusion
The PRIMA trial is a prospective international multicenter double blind randomized trial comparing primary suture closure of midline laparotomy to closure aided with
a prosthetic mesh. This trial might provide the surgical
society a technique to prevent incisional hernia in high
risk patients.
Endnote
a
The initial inclusion criteria featured patients with a
BMI of 30 or higher. However as stated before, a study
was published during the enrolment of this trial demonstrating that patients with a BMI 27 or more could also
be included [35]. We amended our protocol to lower
our inclusions criteria for BMI, from 30 to 27.
Appendix
Criteria for defining a Surgical Site Infection (SSI) [49]
Superficial Incisional SSI

Infection occurs within 30 days after the operation and

infection involves only skin or subcutaneous tissue of
the incision and at least one of the following:
1. Purulent drainage, with or without laboratory
confirmation, from the superficial incision.

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2. Organisms isolated from an aseptically obtained

culture of fluid or tissue from the superficial incision.
3. At least one of the following signs or symptoms of
infection: pain or tenderness, localized swelling,
redness or heat and superficial incision is deliberately
opened by surgeon, unless incision is culture-negative.
4. Diagnosis of superficial incisional SSI by the
surgeon or attending physician.
5. Do not report the following conditions as SSI:
6. Stitch abscess (minimal inflammation and discharge
confined to the points of suture penetration).
7. Incisional SSI that extends into the fascial and
muscle layers (see deep incisional SSI).
Deep incisional SSI

Infection occurs within 30 days after the operation if no

implant is left in place or within 1 year if implant is in
place and the infection appears to be related to the operation and infection involves deep soft tissue (e.g., fascial
and muscle tissue) of the incision and at least one of the
following:
1. Purulent drainage from the deep incision but not
from the organ/space component of the surgical site.
2. A deep incision spontaneously dehisces or is
deliberately opened by a surgeon when the patient
has at least one of the following signs or symptoms:
fever (>38C), localized pain, or tenderness, unless
site is culture negative.
3. An abscess or other evidence of infection involving
the deep incision is found on direct examination,
during re-operation, or by histopathologic or
radiological examination.
4. Diagnosis of a deep incisional SSI by a surgeon or
attending physician.
Notes:
1. Report infection that involves both superficial and
deep incision sites as deep incisional SSI.
2. Report an organ/space SSI that drains through the
incision as a deep incisional SSI.
Organ/Space SSI

Infection occurs within 30 days after the operation if no

implant is left in place or within 1 year if implant is in
place and the infection appears to be related to the operation and infection involves any part of the anatomy (e.
g., organs or spaces), other than the incision, which was
opened or manipulated during an operation and at least
one of the following:
1. Purulent drainage from drain that is placed through
a stab wound into the organ/space.

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2. Organisms isolated from an aseptically obtained

culture of fluid or tissue in the organ space.
3. An abscess or other evidence of infection involving
the organ/space that is found on direct examination,
during reoperation, or by histopathologic or radiologic
examination.
4. Diagnosis of a deep organ/space SSI by a surgeon
or attending physician.
Competing interests
This study was supported by B. Braun Aesculap GmbH, Tuttlingen, Germany
and Baxter Deutschland GmbH, Unterschlieheim, Germany. None of these
sponsors were involved in the design, conduct or analysis of the study.
Disclosure: The authors declare no other conflict of interest.
Authors contributions
JN drafted the original protocol and wrote the protocol manuscript, HHE
drafted following procotol amendments and was involged in patient
inclusion and data gathering, LT drafted following procotol amendments
and was involved in patient inclusion and data gathering, WCJH is the trial
statistician and performed the power analysis and was responsible for the
trial methodology, GJK was involved in writing of the first manuscript and all
following amendments, JJis initiator and creator of the PRIMA trial and was
involved in writing of the first manuscript and all following amendments,
J. F. Lange is initiator and creator of the PRIMA trial and was involved in
writing of the first manuscript and all following amendments, PRIMA Trialist
group were all responsible for including patients, organizing and conducting
follow-up. All authors read and approved the final manuscript.
Acknowledgements
PRIMA Trialist Group
C.W. Burger, Department of Gynecology, Erasmus MC, Rotterdam,
The Netherlands
H.J. Verhagen, Department of Surgery, Erasmus MC, Rotterdam,
The Netherlands
D. de Jong, Department of Gynecology, Erasmus MC, Rotterdam,
The Netherlands
P.J. Klitsie, Department of Surgery, Erasmus MC, Rotterdam, The Netherlands
E.G. Pierik, Department of Surgery, Isala Clinics, Zwolle, The Netherlands
S.S. Lases Department of Surgery, Isala Klinieken, Zwolle, The Netherlands
A.C. van der Ham Department of Surgery, Sint Franciscus Gasthuis,
Rotterdam, The Netherlands
J.J. Harlaar Department of Surgery, Sint Franciscus Gasthuis, Rotterdam,
The Netherlands
J.A. Charbon Department of Surgery, Maxima MC, Veldhoven, The Netherlands
B. Leenders Department of Surgery, Maxima MC, Veldhoven, The Netherlands
I. Dawson Department of Surgery, IJsseland ziekenhuis,Cappele aan de IJssel,
The Netherlands
M. van den Berg Department of Surgery, Scheper ziekenhuis, Emmen,
The Netherlands
N.J. Harlaar Department of Surgery, Scheper ziekenhuis, Emmen,
The Netherlands
C.M Seiler Department of Surgery, Sinsheim Klinikum, Sinsheim, Germany
M.W Buchler Department of Surgery, Universittsklinikum Heidelberg,
Heidelberg, Germany
M.K Diener Department of Surgery, Universittsklinikum Heidelberg,
Heidelberg, Germany
C. Schuhmacher Department of Surgery, Ludwig-Maximilians-Universitt
Mnchen, Mnchen, Germany
A.L Mihaljevic Department of Surgery, Ludwig-Maximilians-Universitt
Mnchen, Mnchen, Germany
J.R. Izbicki Department of Surgery Universittsklinikum Hamburg-Eppendorf,
Hamburg, Germany
A. Kutup Department of Surgery Universittsklinikum Hamburg-Eppendorf,
Hamburg, Germany
P. Neuhaus Department of Surgery, Universittsmedizin Berlin: Charit,
Berlin, Germany
P. Fikatas Department of Surgery, Universittsmedizin Berlin: Charit,
Berlin, Germany

Nieuwenhuizen et al. BMC Surgery 2013, 13:48

http://www.biomedcentral.com/1471-2482/13/48

M. Golling Department of Surgery, Diakonie-Klinikum Schwbisch Hall,

Schwbisch Hall, Germany
D. Laux Department of Surgery, Diakonie-Klinikum Schwbisch Hall,
Schwbisch Hall, Germany
R. Fortelny Department of Surgery, Allgemeines Krankenhaus der Stadt Wien,
Vienna, Germany
C. May, Department of Surgery, Allgemeines Krankenhaus der Stadt Wien,
Vienna, Germany
Author details
1
Department of Surgery, LUMC, Leiden, The Netherlands. 2Department of
Surgery, Erasmus MC, Rotterdam, The Netherlands. 3Department of
Epidemiology, Erasmus MC, Rotterdam, The Netherlands. 4Department of
Neuroscience, Erasmus MC, Rotterdam, The Netherlands.
Received: 2 April 2013 Accepted: 26 September 2013
Published: 28 October 2013

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doi:10.1186/1471-2482-13-48
Cite this article as: Nieuwenhuizen et al.: A double blind randomized
controlled trial comparing primary suture closure with mesh
augmented closure to reduce incisional hernia incidence. BMC Surgery
2013 13:48.

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