Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study
Phase: NA
Conditions: Abdominal Wall Hernia, Umbilical Hernia Repair, Epigastric Hernia Repair
Sponsor: Regionshospital Nordjylland

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Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar 
Mesh in Ventral Hernia Treatment – a randomized, blinded 
multicenter study 
 
 
 
Version 1.3 (07.07-25)  
VMK-id: 2502170  
Region Nordjylland-id: xxxxx  
 
 
Coordinating center and data center: 
Department of Surgery  
Regionshospital Nordjylland 
Bispensgade 37, 9800 Hjørring 
 
 
 
 
 
 
Coordinating investigator:  ________________________________________________ Vitaly Gameza, MD  
Sponsor:  _______________________________________ Kathrine Holte, associate professor, MD, DMSc  
 
 

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TABLE OF CONTENTS 
 
PARTICIPATING CENTERS ............................................................................................................................ 3 
PROTOCOL SUMMARY ................................................................................................................................. 3 
INTRODUCTION ............................................................................................................................................. 5 
BACKGROUND ............................................................................................................................................... 5 
AIM/PURPOSE ................................................................................................................................................. 6 
HYPOTHESIS ................................................................................................................................................... 7 
MEDICAL DEVICE .......................................................................................................................................... 7 
METHOD .......................................................................................................................................................... 7 
Study design ................................................................................................................................................... 8 
Study population and sample size .................................................................................................................. 8 
Inclusion criteria ............................................................................................................................................ 8 
Exclusion criteria ........................................................................................................................................... 8 
Recruitment of study subjects ........................................................................................................................ 8 
Randomization ............................................................................................................................................... 9 
Blinding.......................................................................................................................................................... 9 
Study interventions ........................................................................................................................................ 9 
Outcomes ..................................................................................................................................................... 10 
Primary outcome ...................................................................................................................................... 10 
Secondary outcomes ................................................................................................................................ 11 
Sub-study 1: Long-term recurrence ............................................................................................................. 11 
Sub-study 2: Long-term outcomes ............................................................................................................... 11 
Sub-study 3: Socio-economic aspects .......................................................................................................... 11 
Study duration .............................................................................................................................................. 11 
Safety assessment and study termination ..................................................................................................... 11 
Statistical methods ....................................................................................................................................... 11 
STUDY MONITORING .................................................................................................................................. 12 
ACCESS TO PARTICIPANTS MEDICAL RECORDS ................................................................................. 12 
Patient sensitive information........................................................................................................................ 13 
PERSPECTIVES ............................................................................................................................................. 13 
ETHICAL CONSIDERATIONS ..................................................................................................................... 13 
PROJECT MANAGEMENT ........................................................................................................................... 14 
Timeline and study feasibility ...................................................................................................................... 14 
Data analysis plan ........................................................................................................................................ 14 
DATA MANAGEMENT AND SECURITY .................................................................................................... 14 

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GOOD CLINICAL PRACTICE ...................................................................................................................... 14 
PROJECT GROUP AND MANAGEMENT STRUCTURE ........................................................................... 15 
PUBLICATIONS AND AUTHORSHIP.......................................................................................................... 15 
FINANCIAL ASPECTS AND CONFLICTS OF INTEREST ........................................................................ 15 
REFERENCES ................................................................................................................................................ 16 
APPENDIX 1: .................................................................................................................................................. 17 
 
PARTICIPATING CENTERS 
 
Department of Surgery  
Regionshospital Nordjylland  
Bispensgade 37  
9800 Hjørring Denmark  
SI: Vitaly Gameza, MD  
 
Department of Surgery  
Regionalhospital Randers  
Skovlyvej 15   
8930 Randers, Denmark  
SI: Marlene Sørensen, MD  
Department of Surgery  
Hospital Unit Midt, Viborg  
Heibergs Alle 5A   
8800 Viborg, Denmark  
SI: Marie Kirk, MD 
 
Department of Surgery  
Regionshospitalet Horsens  
Sundvej 30  
8700 Horsens  
SI: Michael Festersen, MD, PhD 
  
  
 
 

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PROTOCOL SUMMARY 
 
Title:  
Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Regular Mesh in Ventral 
Hernia Treatment – a randomized, blinded, multicenter study  
Acronym:  
MeMa 
Study Sponsor:  
Kathrine Holte 
Protocol version:  
1.3 (07.07.2025) 
Coordinating investigator:  
Vitaly Gameza 
Study sites:  
a) Regionshospital Nordjylland, Hjørring  
b) Regionshospital Randers  
c) Regionshospitalet Viborg  
d) Regionshospital Horsens 
Investigators and 
clinical study 
coordinators: 
Coordinating investigator:  
Vitaly Gameza  
Site investigators (according to above mentioned sites):  
a) Kathrine Holte, MD, DMSc/Vitaly Gameza , MD 
b) Marlene Sørensen, MD  
c) Marie Kirk, MD  
d) Michael Festersen, MD, PhD 
Other collaborators:  
Center for Klinisk Forskning, Regionshospital Nordjylland 
Dansk Center for Sundhedstjenesteforskning, Aalborg Universitet. 
Funding organizations 
Investigator initiated. Funding will be sought from various non-profit foundations. As 
of now (July 7th 2025) only internal funding from Regionshospital Nordjylland has 
been secured. 
Indication:  
Patients with small (< 3*3 cm) ventral hernia, with indication for onlay mesh repair. 
Aim:  
Superiority of mesh suture repair. 

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Hypothesis:  
By using mesh suture, most of the subcutaneous dissection may be avoided and thus our 
hypothesis is that by reducing the surgical trauma, we may reduce wound complications 
from 14% to 4%, as well as reduce the operation time. 
Study design:  
Multicenter, blinded, randomized, controlled trial. 
Planned sample size:  
 280 (140 in each arm) 
Total number of centers:  
4 
Screening:  
All patients presenting with small (< 3*3 cm) ventral hernia in the outpatient clinic. 
Selection criteria:  
Capable adults (age > 18 years) where indication for open surgery with onlay planar 
mesh is found.  
Study interventions:  
Mesh suture vs. planar mesh repair. 
Primary outcome  
Surgical site occurrences (SSOs) 
Analysis plan:  
No interim analysis is planned. Full analysis will thus be performed after inclusion of 
the planned sample size of 280 participants. 
Duration of study:  
Patient inclusion 1,5-2 years, 5 years follow up. 
 
INTRODUCTION  
In this multi-center, blinded, randomized study, we compare two medical devices to treat small ventral 
hernias: Mesh suture (intervention) vs. planar mesh (standard treatment).  
Implantation of mesh suture does not require the subcutaneous preparation of abdominal wall needed to 
implant planar mesh. Thus, we hypothesize that the reduced surgical trauma following mesh-suture 
implantation promotes better postoperative outcomes, primarily reduced wound complications such as 
seroma, hematoma and wound infections. Additionally, the shorter operation time associated with mesh-
suture implantation may substantially reduce hernia waiting lists, which approximate 41 weeks in some 
public hospitals in Denmark. Finally, we will assess patient-reported outcomes (PROMs) such as Quality of 
Life (QoL) before and after surgery and analyze socio-economic parameters potentially affected by mesh-
suture implantation, such as return to work and contact with family physician/primary sector.  

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BACKGROUND 
Surgery for small ventral hernias (< 2 cm) is one of the most frequently performed operations in Denmark, 
with 2469 procedures performed in 2023. Despite it being a relatively small operation, up to 7.1% of 
patients are readmitted to emergency departments <90 days after surgery, primarily due to wound problems, 
and up to 2.2% of patients are reoperated <30 days after surgery1. Historically, the two most important 
outcome measures following small ventral hernia repair are postoperative wound events and long-term 
hernia recurrence2. Current standard treatment of these hernias in Denmark is open surgery with onlay 
planar mesh placement. With onlay planar mesh, the hernia sack is dissected and reduced, the abdominal 
wall defect closed with a non-dissolvable suture, subcutaneous tissue dissected from the underlying fascia 
and non-resorbable mesh implanted on top of the fascia. This method is proven superior to closure of the 
hernia defect with only a suture in terms of recurrence rates3,4. There is, however, a higher risk of 
seroma/hematoma formation and wound infection when planar mesh is used compared to suture closure5,6. 
Rates of postoperative seroma formation are reported to be as high as 46% and in our clinical practice, 
readmission to hospital is predominantly caused by seroma formation related to the operative site7.  
Reported rates of surgical site occurrences (SSO) after operations for small ventral hernias vary greatly in 
the literature, additionally there is a lack of standardized definitions and reporting2. In settings comparable to 
ours, one study from Sweden showed complication rates of 23.7% after onlay planar mesh repairs8. The 
higher rate of hernia recurrence with suture only repair is attributed to the suture cutting through tissue 
(“cheese wire cutter effect/ or suture pull-through effect“), which occur when the  sharp leading edge of the 
suture applies focused pressure at the suture/tissue interface and the pressure causes either abrupt cutting of  
tissue or a more gradual process of tissue ischemia and scarring, remodeling over time. In experimental 
studies, low suture tension has been found to promote more favorable collagen composition of the incisional 
region9. Planar mesh implantation redistributes tension forces over a large surface area so the edges of fascia 
have optimal conditions for healing, but at the cost of higher wound complications rates and longer 
operation time.   
Several methods have been developed to reduce fascial tension during healing without extensive dissection 
of suprafascial or subfascial tissue. Among those are mesh sutured repairs where 2 cm wide mesh strips are 
used to close fascial defects just as with single tread interrupted suture. Mesh sutured repairs showed 
promising results even in contaminated fields and larger defects10. Mesh sutured technique is however 
subject to many variables that may alter its efficacy, such as accurate strip cutting, strip passing technique 
and mesh availability at the hospital.  
Recently, a mesh suture has been developed (our proposed study intervention), with an attached needle and a 
tubular design with pores in the wall, combining functions of both suture and mesh, allowing ingrowth of 
tissue without capsule formation, while having the tensile strength nearly identical to those of a 0-

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polypropylene suture11. Available data support the safety and efficacy of this mesh suture for abdominal wall 
closure12. 
AIM/PURPOSE  
The aim of this randomized, blinded multicenter trial is to investigate differences in wound complication 
rates (SSO), PROM (Quality of Life) and operation time among patients operated for small ventral hernias 
either with mesh-suture or planar mesh as well as evaluate potential influence of mesh-suture on wider 
socio-economic parameters such return to work and contact with family physician/primary sector. 
HYPOTHESIS  
By using mesh suture, extensive subcutaneous dissection is avoided and surgical trauma is minimized, 
leading to reduced wound complication rates.   
MEDICAL DEVICE  
 
In this head-to-head study we intend to compare two medical devices. Both devices are used under the 
respective CE approved indications.  
In the control group we use Optilene® Mesh. Manufacturer: B. Braun Surgical, S.A. Ctra. d e Terrassa, 121 
08191 Rubí (Barcelona), Spain. CE Certificate G1 025701 0090 Rev.01.  
Optilene® Mesh is a mesh implant for reinforcement of connective tissue structures. It is constructed from 
monofilament polypropylene, knitted to a thin and elastic shape-stable mesh. After implantation, the 
Optilene® Mesh adapts to the longitudinal and latitudinal expansions taking place in the connective tissue. 
Optilene® Mesh is coloured blue with copper phthalocyanine (Phthalocyaninato (2-) copper) for a better 
visibility. Optilene® Mesh does not possess any independent pharmacological properties. The polypropylene 
mesh is biostable and is not degraded in the body. 
In the intervention group we use suturable mesh, DURAMESH™. Manufacturer: Mesh Suture Inc. 1444 
North Astor Street, Chicago, IL, 60610, United States. Authorized representative: Emergo Europe, 
Prinsessegracht 20, 2514 AP The Hague, The Netherlands. CE Certificate US21/819944390  
DURAMESH™ is a non-absorbable polypropylene suturable mesh and combines the desirable principles of 
a mesh repair with the placement precision of a suture. DURAMESH™ distributes forces at the suture-tissue 

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interface, while dramatically minimizing the amount of implanted foreign material and surgical complexity 
required for implantation. DURAMESH™ is constructed from monofilament polypropylene and has an 
open walled, hollow core design that allows fibrovascular incorporation into the device during healing.  
DURAMESH™ does not possess any independent pharmacological properties. The polypropylene suturable 
mesh is biostable and is not degraded in the body. 
METHOD  
 
Study design 
Multicenter, blinded, randomized controlled trial. The study is powered as a superiority study with intention 
to treat analysis.  
Study population and sample size  
In the litterature, wound complication incidences vary greatly (from 0.7 to 63.3%), at least in part due to a 
lack of standardized definitions and reporting2. We know that in our department the readmission rate after 
small ventral hernia repair is 7% (data from the National Hernia Database, 2023)1. The majority of 
these readmissions is due to wound complications. We estimate that least as many patients are treated 
for minor SSO in primary sector as in the hospitals (unpublished data), so the true incidence of wound 
complications is estimated around 14 percent for onlay mesh.  
In the literature12 the reported surgical site event rate for umbilical hernias is 2.4%, with infection rates of 
4.9%. For ventral hernias, surgical site events range from 1% to 8.2%, while infections range from 3.1% to 
5.2%. 
It is also important to note the wound classification in the referenced study12: 
• 
Umbilical hernias: 14.6% were classified as clean-contaminated 
• 
Ventral hernias: 18.6% clean-contaminated and 12.4% contaminated 
In our study, all procedures are performed in an outpatient setting and involve only clean wounds. 
Additionally, 13% of patients in the referenced cohort were active smokers, despite smoking being a well-
established risk factor for postoperative wound complications. In our study, the rate of active smoking 
is 0%, as all participants are required to be smoke-free for at least six weeks preoperatively, with random 
testing performed to verify compliance. 

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Based on these distinctions, our realistic expectation for wound complications is 1–3%. However, to remain 
appropriately conservative, we have chosen to report an estimated complication rate of 4%. 
A reduction in wound complications  from 14% to 4%  is considered clinically significant.  
A sample size of 254 participants was determined to have 80% power to detect a clinically significant 
between-group reduction in surgical site occurrences (seroma/hematoma formations and postoperative 
wound infections) from 14 to 4% and a type I error of 5%, without increase in recurrences. This number was 
increased to 280 participants to account for conversions and cases lost to follow-up.  
No interim analyses are planned. The planned sample size is 280 patients with equal assignment to the two 
groups.  
Inclusion criteria  
All patients presenting with small ventral hernia, maximum 3x3cm, where indication for open surgery with 
planar mesh is found.  
Exclusion criteria  
Age <18 years  
Acute operation 
Pregnancy  
Women with plans of future pregnancies   
Withdrawal of informed consent during admission 
Recruitment of study subjects  
Patients are screened at the participating centers outpatient departments. If the candidate meets the inclusion 
criteria, the candidate will receive oral and written information about the study from one of the operating 
surgeons. Patients will be asked to read the information in the entity before signing. All patients are invited 
to discuss the entry into the study with a relative or other entrusted person if they so choose. Informed 
consent will take place in a quiet room without interruption on the day of the inclusion.  Patients are 
informed that the consent could be withdrawn at any time prior to randomization (or after) and so the real 
timeframe to decide if patients wish to participate would be approximately 4 weeks.  
Randomization  
After provision of consent, randomization is performed by the operating surgeon during the operation, the 
moment where it is ensured that onlay planar mesh is not superior to mesh-suture e.g. more/larger fascia 
defects than anticipated are not found. Random sequence generator with random block size (of maximum 
10) will be used to create randomized sequences in 1:1 ratio. In all participating centers, a case of 

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sequentially marked opaque envelopes will be made available. The envelopes contain patient study ID, 
information on the assigned intervention group and the registration schematics along with information on 
when to perform registrations.   
Blinding  
Patients will be blinded until the end of follow-up, which is planned to be 5 years.  
Blinding of trial participants: 
Blinding is maintained by ensuring that the operative report only states: “… a mesh is implanted according 
to the study protocol and randomisation number ...”. This prevents patients from being able to see which 
type of mesh was used. 
Blinding of the assessing physician: 
The physician who performs the follow-up assessment for wound complications is never the operating 
surgeon. Furthermore, the local database is configured so that the assessing physician does not have access 
to the section where the operating surgeon records the specific type of implanted mesh. 
Furthermore, all surgeons involved will receive detailed information about entering relevant basic data in a 
local database (redcap) and all performed operations are registered in the Danish National Herniadatabase as 
well. All patients will be contacted by a nurse/study group member who is unaware of randomization results 
and treatment given in order to collect PROM data. 
 

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Study interventions  
The objective criteria for surgery are described in the guidelines of the Danish Hernia Database 
(appendix 2), and all participating centres are obliged to follow them. The guidelines are also attached. 
Included patients will be randomized to either standard treatment with planar mesh or interventional 
treatment with mesh-suture. All hernia will be operated by consultant surgeons, fellows or residents after 
proven competency, possibly with supervision. Details of the operation with either planar mesh or 
Duramesh, in appendix 3 and 4. Centers involved in the trial will be invited to a session where we go 
through operation details to secure that the procedure is performed in a standardized manner in all centers. 
Younger surgeons in all centers will be allowed to perform the operation under supervision of senior 
colleagues who attend the educational session and later without supervision if they are evaluated as being 
able to do so. Detailed information with pictures regarding steps for both operations with suture or planar 
mesh will be available in every center.   
Baseline data and preoperative QoL score will be collected during the first visit in the out-patient clinic or 
immediately preoperatively, if the patient consents to study participation.  
All patients will be called in for clinical examination on postoperative day 7-13, where standardized wound 
inspection (see appendix 1) and ultrasound will be performed just as QoL will be assessed by a standardized, 
validated questionnaire. QoL will be assessed by telephone on day 90, 1 year, 3 years and 5 years after 
surgery as well.  
Operation time is defined as time from first incision to last cutaneous suture and is registered by the floor-
nurse in the operation room.  
90 days after surgery patient journals will be assessed concerning data on potential readmissions. 
 
Table 1. Overview, patient management 

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Outcomes  
Primary outcome  
1. Surgical site occurrences (SSO) on postoperative day 7-13.  Definition: We will apply the standardized 
CDC (Centers for Disease Control and Prevention )13 and VHWG (Ventral Hernia Working Group)2 
definitions for SSO (appendix 1). Evaluation: Clinical examination. Additionally, an ultrasound examination 
will be performed.  
Secondary outcomes  
2. QoL on postoperative day 7-13 and day 90. Definition and evaluation: The EHS (European Hernia 
Society) validated EuraHS-quality-of-life (QoL) score (attached). 
3. Duration of surgery (min).  
Sub-study 1: Long-term recurrence  
In this sub-study we will assess hernia recurrence events in both study subgroups after 1, 3 and 5 years.  
Sub-study 2: Long-term outcomes  
In this sub-study we will assess QoL as defined above in both subgroups after 1 year.  
Sub-study 3: Socio-economic aspects  
In this sub-study we will assess socio-economic parameters (specifically time to return to work, analgesic 
use and contact with the primary sector) in both groups on postoperative day 7-13, 90 and after 1, 3 and 5 
years. 
Study duration  
Patient inclusion: 2 years from September 2025 - September 2027, plus 5 years follow-up.  

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Safety assessment and study termination  
Conversion of intervention to standard treatment: If, after randomization, interventional treatment is 
impossible to apply, then standard treatment will be performed.  
The study will be terminated if the complication rate for patients operated with mesh suture exceeds known 
complication rates for planar mesh. Adverse events will be assessed and registered 7-13 days after surgery 
by clinical examination and 90 days after surgery by phone as well as by going through patient medical 
records. 
Statistical methods  
A sample size of 254 participants was determined to have 80% power to detect a clinically significant 
between-group reduction in surgical site occurrences from 14 to 4% and a type I error of 5%. This number 
was increased to 280 participants to account for conversions and cases lost to follow-up. No interim analyses 
are planned.  
Data will be analyzed by a blinded analyst on an intention-to-treat basis, according to the prespecified 
statistical plan. A two-sided P-value < 0.05 is considered significant.  
Analysis of the primary outcomes: Depending on the distribution of data, continuous variables will be 
described with mean (SD, standard deviation) or median [interquartile range (IQR)] and analyzed with 
students t-test or Mann-Whitney U test, respectively. Categorical variables will be described as frequencies 
(%) and analyzed using Fisher´s exact test.  
Analyses will be conducted using Stata software.  
STUDY MONITORING  
The coordinating investigator , a medical specialist and a dedicated hernia surgeon with more than 12 years 
of surgical experience, has the general responsibility for study monitoring and will secure that all legal and 
practical aspects of the study protocol are followed in all participating centers.   
The coordinating investigator will receive weekly reports of performed operations from all participating 
centers and secure that all relevant data are submitted to a central database. If there is any baseline data 
missing, participants will be contacted. The database will be monitored on a weekly basis. Medical journals 
of all participants will be accessed on day 90 after the operation to secure all relevant data are collected. 
Access to data after submission will be restricted only to relevant study investigators to comply with the 
blinded study design. A dedicated nurse with over 15 years of experience in nursing hernia patients will 
contact all study participants on day 90 after operation and if there is any suspicion of deviation from the 
expected post operative course, participants will be called in for physical/radiological examinations. All 
study participants are informed to contact medical emergency services anytime if required.  

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ACCESS TO PARTICIPANTS MEDICAL RECORDS  
To ensure the safety of participants and to collect the research data upon trial completion, access to 
electronic patient files will be needed throughout the trial. Access to the electronic patient journal will be 
needed to get data on surgery performed, clinical outcomes, readmissions and CT-scans (descriptions). 
Patients will be asked to give explicit informed consent to data access for their electronic patient journal 
until the study period ends. Participants will be asked to give access to information in a 5-year period after 
inclusion.  Information will be given about the intended use of the data as well as the intent to publish in 
international journals. Before participation in the study all eligible patients will be asked to give a written 
consent that the principal/coordinating investigator, local site investigators, sponsor, investigating nurse and 
eventual controlling authority may have direct access to patients medical records hereunder electronic 
patient journal in order to access patients medical data which is necessarry for study implementation and 
control hereunder self-control, quality control and study monitoring. Patient data will be handled in 
accordance with “Databeskyttelsesloven og -forordningen”, the Danish adaptation of the European Union 
General Data Protection Regulation (GDPR). If patients are not interested in study participation, no data will 
be collected for the study.  
Patient sensitive information  
All patient sensitive data will be anonymized prior to publication. All data protection regulations and data 
protection law will be followed. No data will be sent to other countries. 
PERSPECTIVES  
One of the principles of good surgical practice is to cause as minimal surgical trauma as possible. By using 
mesh suture, we may substantially reduce the trauma caused by surgery. By avoiding dissection of 
subcutaneous tissue from underlying fascia, we preserve the perforant arteries which are usually divided and 
ligated. We furthermore avoid creating an artificial space between subcutis and fascia where seroma and 
abscesses may accrue. By reducing surgical trauma, we anticipate better QoL regarding, among others, pain, 
discomfort and mesh related complications such as foreign body sensations related to the surgical site.  Less 
trauma potentially may lead to faster recovery, shorter return to work times, less use of family doctors, so we 
anticipate an over-all reduction in the socio-economic burden.  
Our expectations are to reduce operation time by 30%, which will potentially allow us to operate on more 
patients per day as well as reducing waiting time to operation and thus theoretically reduce numbers of acute 
operations. In the planned sub-studies with longer follow-up, we will assess hernia recurrence rates to ensure 
that mesh suture is not inferior to planar mesh.   

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ETHICAL CONSIDERATIONS  
Potential benefits, risks and side-effects by participation  
Use of mesh suture is simple and resembles standard suture use, thus all surgeons who perform ventral 
hernia repair would easily be able to use the technique.  
A potential concern is a potentially higher recurrence rate among patients operated with mesh suture. We 
will review all collected data after 3 months by a project member not otherwise involved in the project, and 
if early (<90 days) recurrence rates in mesh suture subgroup exceed national average reoperation rates (2%), 
the study will be terminated. If recurrence appears, patients will be offered standard treatment with planar 
mesh. It is important to mention that reoperation in case of recurrence would be easy to perform due to lack 
of prior extensive dissection of subcutaneous tissue and thus less fibrosis.  
Patients will expectedly be subject to increased awareness regardless of whether they are randomized to the 
intervention group or standard treatment, as this is a known phenomenon of study participation. This may 
make treatment safer in both groups.   
Study participants will not receive financial compensation or other benefits and will be treated according to 
the Helsinki declaration. Complications directly attributable to the treatment will be eligible for insurance 
claims from the Danish public patient insurance (“Patienterstatningen”).  
PROJECT MANAGEMENT  
Timeline and study feasibility  
Due to high volume of small ventral hernia operations (2469 nationwide in 2023), the time frame estimated 
for patient inclusion is realistic and is estimated to be 1-2 years depending on the number of centers wishing 
to join the trial.  
Data analysis plan  
It is estimated that completion of statistical analyses, interpretation of results and submission for publication 
will take 6-12 months. The analyses from sub-studies 2 will be initiated 1 year after inclusion of the last 
patient and are estimated to take 6-12 months to complete including submission for publication.  
Table 2. Overview, project timeline 

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DATA MANAGEMENT AND SECURITY  
Study data are collected and managed using the encrypted REDCap electronic data capture tools hosted at 
Region Nordjylland18. REDCap (Research Electronic Data Capture) is a secure, web-based application  
designed to support data capture for research studies, providing 1) an intuitive interface for validated data  
entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export  procedures 
for seamless data downloads to common statistical packages; and 4) procedures for importing  data from 
external sources.  
The project will be registered in the North Denmark Region common registry for ongoing trials. When 
approved by the ethical board, the protocol will be made available on https://www.clinicaltrials.gov.  
GOOD CLINICAL PRACTICE  
The project will adhere to the ICH good clinical practice (GCP) guidelines.  
PROJECT GROUP AND MANAGEMENT STRUCTURE  
The project management group and study board are all employed at the coordinating center at 
Regionshospital Nordjylland, Hørring. Kathrine Holte will serve as the project sponsor/principal investigator 
and thus will be responsible for overseeing the study including financial decisions. Vitaly Gameza will serve 
as coordinating/principal investigator and thus will be responsible for the overall clinical implementation 
across research sites and the scientific goals of the study. Kathrine Holte is a clinical associate professor and 
consultant surgeon and a Doctor of Medical Science with many years of research experience from a variety 
of clinical studies. Vitaly Gameza is a medical doctor and hernia specialist.    

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Below, in Danish, the steering group: 
 
PUBLICATIONS AND AUTHORSHIP  
All results from the trial will be published in international peer-reviewed journals independently of study 
outcome. Authorship will be attributed according to the International committee of medical journal editors 
(ICMJE) guidelines.  
FINANCIAL ASPECTS AND CONFLICTS OF INTEREST  
The study is investigator initiated and sponsored by the surgical department of Regionhospital Nordjylland, 
Hjørring and the Clinical Research Unit, Regionhospital Nordjylland, Hjørring and external funding will be 
sought. Any potential funding will be used to cover salary (Vitaly Gameza, project nurse) and the cost of the  
materials. Funding will be payed to the Department of Surgery, Regionshospital Nordjylland. None of the 
researchers have any economic affiliations to potential funds or other entities with economic interest in the 
study. 
REFERENCES 
1 
Dansk Herniedatabase Årsrapport 2023. . 
2 
Haskins IN, Horne CM, Krpata DM, et al. A call for standardization of wound events reporting 
following ventral hernia repair. Hernia 2018; 22: 729–36. 
3 
Dias Rasador AC, da Silveira CAB, Lima DL, et al. Mesh versus suture for elective primary umbilical 
hernia open repair: a systematic review and meta-analysis. Hernia. 2024; 28: 2069–78. 

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4 
Henriksen NA, Jensen KK, Bisgaard T, Helgstrand F. Suture or Mesh Repair of the Smallest 
Umbilical Hernias: A Nationwide Database Study. World J Surg 2022; 46. DOI:10.1007/s00268-022-
06520-1. 
5 
Kaufmann R, Halm JA, Eker HH, et al. Mesh versus suture repair of umbilical hernia in adults: a 
randomised, double-blind, controlled, multicentre trial. The Lancet 2018; 391. DOI:10.1016/S0140-
6736(18)30298-8. 
6 
den Hartog D, Dur AHM, Tulnebreijer WE, Kreis RW. Open surgical procedures for incisional 
hernias. J Perioper Pract. 2009; 19. DOI:10.1002/14651858.CD006438.pub2. 
7 
Bisgaard T, Kehlet H, Bay-Nielsen M, Iversen MG, Rosenberg J, Jørgensen LN. A nationwide study 
on readmission, morbidity, and mortality after umbilical and epigastric hernia repair. Hernia 2011; 15. 
DOI:10.1007/s10029-011-0823-z. 
8 
Bergström M, Widhe B, Granåsen G, et al. Onlay mesh versus suture repair for smaller umbilical 
hernias in adults-early results from SUMMER trial: randomized clinical trial. BJS Open 2024; 9. 
DOI:10.1093/BJSOPEN/ZRAE173. 
9 
Höer JJ, Junge K, Schachtrupp A, Klinge U, Schumpelick V. Influence of laparotomy closure 
technique on collagen synthesis in the incisional region. Hernia 2002; 6. DOI:10.1007/s10029-002-
0070-4. 
10 
Lanier ST, Dumanian GA, Jordan SW, Miller KR, Ali NA, Stock SR. Mesh sutured repairs of 
abdominal wall defects. Plast Reconstr Surg Glob Open 2016; 4. 
DOI:10.1097/GOX.0000000000001060. 
11 
Dumanian GA, Tulaimat A, Dumanian ZP. Experimental study of the characteristics of a novel mesh 
suture. British Journal of Surgery 2015; 102. DOI:10.1002/bjs.9853. 
12 
Hackenberger PN, Mittal M, Fronza J, Shapiro M. Duramesh registry study: short-term outcomes 
using mesh suture for abdominal wall closure. Front Surg 2023; 10: 1321146. 
13 
CDC, Ncezid, DHQP. Surgical Site Infection Event (SSI). https://www.cdc.gov/nhsn/pdfs/ps-analysis-
resources/ImportingProcedureData.pdf. 
  
  
 
 

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APPENDIX 1: 
 
Definition of SSO: 
The standardized definition for surgical site infection (SSI) as defined by the Centers for Disease Control and Prevention (CDC): 
An infection that occurs in the part of the body where the surgery took place and includes superficial, deep, and organ space 
SSIs2,13. 
The standardized definition for SSO as defined by the VHWG includes any SSI as well as wound cellulitis, non-healing incisional 
wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch 
abscess, seroma, hematoma, infected or exposed mesh, or development of an enterocutaneous fistula2.  All complications will 
furthermore be classified according to the Clavien-Dindo classification system. 
APPENDIX 2: 
See separate file Danish Hernia Database guidelines 
APPENDIX 3: 
 
 
APPENDIX 4: 
 

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