Mesh Suture for Internal Load Bearing Closures
Phase: NA
Conditions: Suture; Complications, Mechanical, Suture; Complications, Infection or Inflammation, Suture, Complication
Sponsor: Wigmore Clinic

CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
CLINICALINVESTIGATIONPLAN(CIP)  TITLE:  Mesh  Suture 
PRINCIPAL  INVESTIGATOR: 
Dr.  Garen  Koloyan 
Wigmore  Clinic,  56  Pushkin  Street,  0002  Yerevan,  Armenia 
30  June  2018;  Revised  19  April  2019 
OBJECTIVES 
Determine  whether  Mesh  Suture  achieves  an  acceptable  safety  and  efficacy  profile with the appropriate 
performance for internal load bearing closures, and with acceptable risks and benefits.   
BACKGROUND 
Sutures  are  flexible  linear  elements  that  appose  tissues  and  are  "self-holding"  with  a  surgically 
created  knot.  When  tissues  are  under  tension,  such  as  the  closure  of  an  abdominal  wall  after 
laparotomy,  the  sutures  cut  through  the  tissues  in  what  is  known  as  "suture  pull-through"  and  create 
incisional  hernias.  The  hernia  rate  after  primary  laparotomy  depends  on  the  patient  population,  but  is 
over  10%.  In  some  high-risk  populations,  even  with  a  small  3  cm  laparoscopy  incision,  the  hernia  rate 
is  over  30%.  In  primary  hernia  repair,  use  of  sutures  alone  yields  a  60%  hernia  recurrence  rate  at  10 
years.  Mesh  has  become  commonplace  in  order  to  decrease  incisional  hernia  recurrence  rates  in 
primary  hernia  repairs. 
A  novel  mesh  suture,  designed  at  Northwestern  University  (Chicago,  IL)  by  Dr.  Gregory  Dumanian, 
has  shown  improved  outcomes  in  pre-clinical  animal  models  and  these  results  are  included  at  the  end 
of  this  document.  Dr.  Dumanian  has  employed  the  concept  of  using  a  mesh-like  suture  already  in  his 
clinical  practice.  He  has  cut  strips  from  an  FDA-approved  piece  of  hernia  mesh,  and  used  them  as 
sutures,  tying  them  with  knots. 
Based  on  improved  outcomes  in  pre-clinical  and  analogous  clinical  data  in  comparison  to  standard 
suture,  Dr.  Dumanian  now  proposes  the  use  of  a  medical  grade  mesh  suture  of  his  design  and 
fabrication  in  the  treatment  of  orthopedic  conditions.  These  are  internal  permanent  sutures  and  will  not 
be  removed.  They  are  made  of  the  identical  material  (polypropylene)  used  in  standard  sutures.  In  fact, 
the  mesh  sutures  are  12-14  standard  surgical  sutures  that  are  braided  to  create  a  single  mesh  suture. Dr.  
Dumanian  had  a  meeting  with  the  FDA  (see  attached  File  A)  in  December  2016.  At  that  meeting,  it was  
decided  that  the  Mesh  Suture  did  not  represent  a  significant  added  risk  over  that  of  standard suture,  
and  therefore  would  be  able  to  follow  a  510(k)  pathway  without  a  clinical  trial.  However,  in order  to  
gain  clinical  data  before  official  product  launch,  we  propose  this  clinical  trial. 
STUDY  TIMELINES 
It  will  take  approximately  12  months  to  accrue  80  patients  into  the  study.  The  patients  will  be 
followed  1  year  after  the  implantation  of  the  mesh  suture.  It  will  take  approximately  3  months  to  collect 
the  data  after  the  final  patient  has  had  their  one-year  final  examination. 

STUDY  ENDPOINTS 
30  days  and  12  months 
PRIMARY  OUTCOMES 
1. Surgical  site  occurrence  (SSO)  within  30  days
 
Superficial  infection 
 
Deep  infection 
 
Dehiscence 
 
Hematoma 
 
Necrosis 
 
Non-healing  wound 
 
Seroma 
2. Delayed  infection  or  sinus  within  1-12  months
 
Office  removal  of  suture  or  knot 
 
Return  to  the  operating  room  (OR)  for  draining  wound 
      Knot removal for palpability (added April 20, 2019) 
SECONDARY  OUTCOMES 
1. Operating  room  handling  of  suture
o
Surgeon  satisfaction  with  suture  for  repair  of  tissues  (min  1,  max  5)
o
Intraoperative  suture  breaking  or  fraying  (min  1,  max  5)
o
Quality  of  knot  (min  1,  max  5)
o
Needle  size  and  shape  appropriate  (min  1,  max  5)
2. Rehospitalization  for  any  wound  issue  within  30  days
3. Return  to  the  OR  for  any  reason  within  1-12  months
4. General  rating  of  the  suture  by  surgeon
 
Excellent 
 
Good 
 
Fair 
 
Poor 
INCLUSION  CRITERIA 
Consecutive  patients  undergoing  planned  surgery  at  the  Wigmore  Clinic  and  Arabkir  Joint  Medical 
Center  in  Yerevan,  Armenia,  and  requiring  deep  soft  tissue  approximation  and/or  ligation: 
1.
Age:  more  than  1  year
2.
Gender:  male  or  female
3.
Indications  for  use:  tendon  lengthening,  ligamentoplasty,  tendon  repair,  repair  of  joint
capsules,  other  deep  tissue  approximations
EXCLUSION  CRITERIA 
1. No  planned  need  for  closure  of  deep  soft  tissues
2. Pregnancy
3. Age  less  than  1  year
4. Repair  of  skin  or  other  tissues  with  epithelium

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
 
 
 
 
Indications  for 
Use 
The  Mesh  Suture  is  indicated  for  use  in  soft  tissue  approximation  and/or  ligation. 
Not  to  be  used  for  the  skin. 
Patient 
Population 
Subjects  will  be  recruited  from  a  population  of  patients  treated  for  orthopedic 
conditions  by  Dr.  Garen  Koloyan 
Study  Size  and 
Center 
N=80  patients  at  Wigmore  Clinic  Arabkir  Joint  Medical  Center  in 
Yerevan,  Armenia 
Clinical  Study 
Design 
Safety  and  efficacy  trial  of  a  medical  device  (surgical  suture). 
Prospective,  Non-blinded  and  non-randomized,  Multi-center,  Single-surgeon 
Primary  Safety 
Endpoints 
     Surgical  site  occurrence  (SSO)  with  30  postoperative  days 
     Delayed  infection  or  sinus  within  1-12  months 
Secondary 
Effectiveness 
Endpoints 
     Operating  room  handling 
     Rehospitalization  for  any  wound  issue  within  30  days 
     Return  to  the  OR  for  any  reason  within  1-12  months 
     General  rating  of  the  suture  by  surgeon 
Study  Flow 
SCREENING 
1.  Preoperative  assessment  by  the  surgeon  to  confirm  that  the  patient  meets  the 
study  entry  criteria. 
2.  Informed  consent  obtained  from  patient  by  study  staff. 
 
SURGERY 
1.  Perform  surgery  and  close  deep  tissues  with  Mesh  Suture 
2.  Record  intraoperative  information  on  CRF. 
 
PATIENTS  EXCLUDED  FROM  FURTHER  FOLLOW-UP 
Based  on  the  tissues,  patient's  condition,  and  all  other  intraoperative  factors,  Dr. 
Koloyan  may  decide  not  to  use  a  mesh  suture.  These  patients  will  not  undergo  any 
further  follow-up  nor  be  included  in  the  safety  and  effectiveness  analyses. 
 
INITIAL  FOLLOW-UP 
Patient  follow-up  will  be  per  Dr.  Koloyan's  established  protocols.  All  patients  will  be 
seen  at  least  or  contacted  by  study  staff  by  30  days  to  assess  healing  of  the 
incision  and  assess  for  possible  SSO. 
FINAL  FOLLOW-UP 
Late  patient  follow-up  will  be  per  Dr.  Koloyan's  established  protocols.  All  patients 
will  be  seen  at  least  or  contacted  by  study  staff  by  the  end  of  the  study  period  (12 
months  after  the  surgery)  to  assess  healing  of  the  incision,  functional  outcome  of 
surgery,  and  assess  for  possible  delayed  infection. 
Data  Analysis Clinical  Events  Committee  (CEC)  will  meet  as  necessary  to  review  patient 
outcomes  and  complications.  It  will  comprise  of  the  PI  (Dr.  Garen  Koloyan),  Dr 
Vartges  Avagian,  independent  urologist  in  Yerevan,  and  the  Sponsor’s 
Representative  (Dr.  Gregory  Dumanian). 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
PATIENT SELECTION 
 
Will be at the discretion of the PI, with patients matching inclusion criteria and not have any exclusion 
criteria. The patient should be able to have postoperative follow-up visits and have the appropriate 
guardians to provide consent if under the age of 18. 
 
SAFETY  AND  EFFECTIVENESS 
This  safety  and  effectiveness  study  is  intended  to  demonstrate  that  overall  patient  outcomes  are  no 
worse  than  or  adversely  different  from  the  current  surgical  standard  of  care.  In  addition  to  overall 
patient  outcomes,  the  study  will  also  examine  adverse  outcomes  related  to  the  use  of  the  suture. 
An  overarching  issue  is  that  the  suture  used  in  the  procedure  reflects  only  a  small  part  of  the  total 
treatment  of  the  patient  –  including  what  adverse  occurrences  are  responsible  for  surgical  morbidity 
and  mortality.  Robust  evaluation  of  suture  closures  is  best  assessed  in  the  setting  of  an  animal  study 
where  the  surgical  wound  can  be  opened  and  tested  at  the  end  of  the  follow-up  period.  This  then 
allows  the  investigator  to  readily  inspect  the  suture  line  and  assess  the  abdominal  suture  closure  for 
safety  and  effectiveness  endpoints  including  suture  pull-through.  This  is  not  possible  in  the  treatment 
of  humans.  Therefore,  safety  is  best  noted  by  the  achievement  of  standard  wound  healing  rates  and 
the  absence  of  delayed  infections  in  comparison  to  historical  controls.  Efficacy  is  best  noted  by  the 
achievement  of  standard  functional  outcomes  in  comparison  to  historical  controls. 
DESCRIPTION  AND  ANALYSIS  OF  ALL  INCREASED 
RISKS  TO  THE  RESEARCH  SUBJECTS 
1.  All  of  these  subjects  will  be  undergoing  orthopedic  surgery,  and  there  are  established  baseline 
rates  of  SSO  for  these  procedures.  Each  hospital  will  have  its  own  rate  of  SSO  based  on  the 
procedures  performed  and  the  population  of  that  facility.  While  all  procedures  are  associated  with 
risks  and  SSO,  it  is  not  expected  that  there  will  be  significant  ADDED  risk  to  the  patient  using  a 
mesh  suture  for  a  deep  internal  closure.  In  fact,  animal  data  implies  that  using  a  mesh  suture  will 
result  in  a  stronger  earlier  repair. 
2.  Patients  undergoing  surgery  have  other  risks  of  medical  complications.  It  is  NOT  expected  that 
there  will  be  additive  medical  risks  of  closing  with  mesh  suture. 
3.  Mesh  suture  is  made  of  a  material  commonly  used  for  sutures  (polypropylene),  without  any  added 
chemicals.  It  is  treated  with  heat  and  pressure  –  two  items  that  are  also  used  commercially  in  the 
fabrication  of  hernia  meshes.  The  mesh  suture  has  passed  all  of  the  necessary  FDA  tests  for 
biocompatibility  and  the  absence  of  toxins. 
4.  The  surgeon  does  not  need  to  alter  their  technique  in  any  way. 
5.  It  is  expected  that  a  mesh  suture  closure  will  take  the  same  amount  of  time  as  closures  with 
standard  sutures. 
6.  Mesh  Suture  meets  all  of  the  criteria  as  other  sutures  for  strength  and  the  quality  of  the  needle 
attachment.  It  is  physically  larger  than  other  sutures,  but  achieves  a  small  knot  with  the  collapsing 
of  the  filaments. 
7.  The  protocol  allows  the  use  of  this  suture  in  a  vulnerable  population,  namely  children  under  the 
age  of  18.  Polypropylene  sutures  have  been  used  extensively  in  vascular  and  heart  surgery  in 
children  as  well  as  in  other  soft  tissue  procedures  with  an  excellent  record  for  biocompatibility. 
Therefore,  use  of  mesh  suture  in  this  age  group  does  not  represent  a  significant  added  risk. 

 
Examples  from  the  literature  are  below  of  using  polypropylene  sutures  and  meshes  in  children: 
a.  Perez-Negueruela  C,  Carretero  J,  Mayol  J,  Caffarena  JM.  Surgical  closure  of  multiple 
large  apical  ventricular  septal  defects:  how  we  do  it.  Cardiol  Young.  2017;27(3):588-591. 
 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
b.  Baradaran  N,  Wood  CM,  McCoy  OO,  Prasad  MM,  Stec  AA.  Laparoscopic  intra-abdominal 
patent  processus  vaginalis  ligation  in  pediatric  urology  practice.  J  Pediatr  Urol. 
2017;13(5):512.e1-512.e6. 
c.  Ordorica-Flores  R,  Figueroa-Portillo  R,  Pérez-Escamirosa  F  et  al.  Pediatric  inguinal  hernia 
repair  with  a  single-incision  approach  using  an  Endo  Close™  suturing  device.  Surg 
Endosc.  2016;30(11):5134-5135. 
d.  An  G,  Zhang  H,  Zheng  S,  Wang  W,  Wu  Q,  Xing  Q.  Minimally  invasive  surgical  closure  for 
doubly  committed  subarterial  ventricular  septal  defects  through  a  right  subaxillary 
thoracotomy.  Interact  Cardiovasc  Thorac  Surg.  2016;23(6):924-928. 
e.  Eltayeb  AA,  Ibrahim  IA,  Mohamed  MB.  The  use  of  PROCEED  mesh  in  ventral  hernias:  a 
pilot  study  on  22  cases.  Afr  J  Paediatr  Surg.  2013;10(3):217-221. 
DATA  AND  SPECIMEN  BANKING 
There  will  be  no  specimens  stored  or  banked. 
Data  will  be  secured  on  the  password-protected  laptop,  with  paper  backups  located  in  a  locked  file 
cabinet  by  Dr.  Koloyan.  Paper  consents  will  be  similarly  located  in  a  locked  file  cabinet. 
Dr.  Dumanian’s  participation  in  the  Clinical  Study  will  be  limited  to  the  following  activities: 
 
Data  analysis 
 
Submission  of  results 
 
Ad  hoc  advisory  to  study  investigators  as  a  CEC  member. 
Dr.  Dumanian  will  not  be  performing  any  of  the  surgeries  in  the  study. 
PROVISIONS  TO  MONITOR  THE  DATA  TO  ENSURE  THE  SAFETY  OF  PARTICIPANTS 
A  data  monitoring  committee  (DMC)  will  be  established  by  the  sponsor  to  review  outcomes  for  these 
patients,  and  the  committee  will  then  categorize  all  complications  as  to  relatedness  to  the  use  of 
surgical  suture.  This  data  will  be  reported  every  other  month  to  the  IRB  and  the  sponsor. 
The  DMC  will  include  at  least  3  members:  two  independent  monitors  –  Dr.  Jonah 
Stulberg  and  Dr.  Samir  Attar  (Northwestern  Feinberg  School  of  Medicine,  Chicago,  IL, 
USA),  a  study  manager  –  Dr.  Davit  Abrahamyan  (Arabkir  Joint  Medical  Center,  Yerevan, 
Armenia)  and  when  necessary  a  statistician will be arranged from the Deparment of Social Medicine, 
Feinberg School of Medicine.  Drs.  Stulberg  and  Attar  have  no  financial  interest  in  the  company, 
Dr.  Stulber  is  in  preparation  to  perform  an  FDA  approved  Mesh  Suture  trial  at  Northwestern 
Memorial  Hospital  (Chicago,  IL,  USA). 
A  moratorium  on  the  use  of  the  suture  will  be  put  in  place  if  three  (3)  early  surgical  dehiscences  of 
deep  tissues  occur,  or  an  SSO  rate  of  15%.  All  complications  and/or  deaths  will  be  reviewed 
for  possible  connection  to  the  suture  used  for  closure.  Upon  any  death  attributed  to  the  means  of 
suture  closure,  there  will  be  a  moratorium  on  this  study.  The  data  monitoring  committee  will 
analyze  these  serious  complications,  and  give  a  report  to  the  IRB  and  the  sponsor  if  the  study  as 
to  the  cause  of  these  serious  complications,  and  if  the  trial  should  continue.  The data will be reported 
every other month to the DMC via email.  All adverse events will be communicated in written form as outlined 
below.  Serious adverse events will be communicated both electronically and by written letter. The sponsor 
will receive this document, and the committee will place a moratorium on further cases for the complication 
rates described above.  The DMC will report to the IEC after [successful] resolution of issues based on 

 
correctable factors including changes to the CIP and patient selection. 
 
Emergency ad-hoc meetings of the DMC will be held upon request by any of the 3 members of the committee 
via Skype. The meetings will be documented by Dr. Stulberg, and a report delivered to the sponsor. 
 
WITHDRAWAL  OF  PARTICIPANTS 
Patients  can  choose  to  withdraw  from  the  study  at  any  time.  As  the  Mesh  Suture  will  already  be 
implanted,  there  is  no  mechanism  for  removal  of  the  suture  other  than  a  repeat  surgery,  and  this  will 
only  be  performed  based  on  clinical  indications. 
 
CLOSURE OF THE STUDY 
 
For this first-in-human use of mesh suture, 80 cases will be performed in this safety and effectiveness 
study.  The hypothesis is that the mesh suture will be equivalent in performance to standard suture. 
The study will be closed upon accrual of 80 patients, final follow-up of these patients.  An early 
moratorium of the study will occur with a 15% rate of SSO, or 3 early and unexpected dehiscenses of 
deep tissue closure attributable to the suture as judged by the data monitoring committee. Early 
closure of the study will occur based on the judgement of the PI, the sponsor, and an early 
demonstration of equivalence to the results of standard suture as judged by a lack of early and late 
infections and appropriate postoperative surgical results demonstrating appropriate tissue 
approximation for internal load-bearing closures. 
 
INFORMATION ON MESH SUTURE 
 
Like all sutures, DURAMESH apposes soft tissue. The device pierces the tissue with the aid of a 
standard needle, and the flexible cylindrical mesh body consisting of braided filaments achieves 
tissue apposition by means of a surgically created knot. The open body macroporous design 
permits tissue ingrowth into and around the braided filaments. 
 
BASIC FEATURE DESIGNS 
 
A needle is swaged to the mesh body to facilitate passage through tissue.  It has a linear and flexible 
design.  The cylinder flattens with radially applied force.  It approximates tissue with the creation of a 
self-holding knot. It allows for tissue ingrowth around the filaments.  The mesh body consists of 
individual filaments that are braided and bonded with heat and pressure.  It is constructed with 
polypropylene filaments that distribute forces through their shape, size, and the number of filaments.  
Linear filaments exist to maintain porosity.  The filaments collapse at the knot to create a smaller knot 
profile.  The mesh bodies are attached to standard surgical needle sizes. 
 
Filament size is an important characteristic for biocompatibility. As has been recently shown in 
independent laboratory studies, the foreign body reaction to small filaments is qualitatively different 
than the foreign body reaction of a larger diameter filament made of the same material.1 This improved 
biocompatibility for smaller filaments was recently discussed in a peer reviewed and accepted 

 
manuscript by Dr. Dumanian. 
 
There are four sizes of DURAMESH: 2-0, 0, Number 1, and Number 2, and each is composed of a 
hollow cylindrical braided weave of standard polypropylene filaments. The DURAMESH 2-0 is 
composed of 12 polypropylene filaments (twelve 100-micron filaments), the DURAMESH 0 is 
composed of 12 polypropylene filaments (four 150-micron filaments and eight 100-micron filaments), 
DURAMESH Number 1 is composed of 18 polypropylene filaments (eighteen 100-micron filaments), 
and DURAMESH Number 2 is composed of 18 standard polypropylene filaments (six 150-micron 
filaments, and twelve 100-micron filaments). 
The polypropylene filaments are braided around a mandrel and then treated with heat and pressure 
to create bonds.  There are no additional chemicals or treatments used in the manufacturing. 
After braiding, the leading edge of the mesh body is attached to a conventional needle via a 
mechanical swaging process.  The curved needle is manufactured from medical grade stainless steel 
470SS that complies with ASTM standard F899. 
 
Mesh Suture is available in USP size equivalents 2-0, 0, Number 1, and Number 2 and will be supplied 
in pre-cut 36-inch lengths. 
 
DIRECTIONS FOR USE 
 
Surgeons should select DURAMESH for indications of internal approximation and/or ligation of soft 
tissues, where there is a potential for suture pull-through or tearing of tissues. Selection of a particular 
DURAMESH suture with a particular needle will depend on the quality of the tissues and the specifics 
of the surgical procedure. The surgeon will rely on his or her years of training, education, and 
experience for DURAMESH size selection.  The surgeon will also be guided by the USP designation, 
namely that a 2-0 DURAMESH will be selected as a substitute for a 2-0 standard suture, and similarly 
for the 0, Number 1 and Number 2 DURAMESH sizes. 
 
BIOCOMPATIBIITY 
 
Based on the FDA guidance for Biocompatibility “Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management    
process”, the device is categorized as an implant, tissue /bone contact, long term ‘C’ duration. 
DURAMESH is manufactured from the same polypropylene material as the predicate device 
‘Sharpoint polypropylene suture’ and is manufactured by the same supplier, Surgical Specialties Corp.  
Biocompatibility testing was performed as per International Standard ISO 10993-1 by 
the NAMSA Corporation (Northwood, OH) including cytotoxicity, sensitization, irritation or 
intracutaneous reactivity, chemical characterization, acute systemic toxicity, material-mediated 
pyrogenicity, genotoxicity, implantation/histology, endotoxin testing, and pyrogen testing. All applicable 
FDA standards were passed for these tests. Carcinogenicity, chronic toxicity, and subchronic toxicity 
are addressed in a "Risk Analysis" by the NAMSA corporation   The needles used for DURAMESH 
are made from 470-grade stainless steel surgical wire. 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Sutur
e 
POTENTIAL  RISKS  TO  PARTICIPANTS 
The  Mesh  Suture  will  be  manufactured  (fabrication,  sterilization  and  packaging)  using  GMP  standards 
by  one  of  the  largest  suture  companies  in  the  world,  Surgical  Specialties.  The  risk  of  contamination  or 
inadequate  preparation  is  very  low  considering  the  experience  of  the  manufacturer.  This  will  minimize 
the  risk  of  an  issue  with  the  suture  itself  (sterility,  composition,  tensile  characteristics,  etc.)  to  the 
patient. 
The  overwhelming  majority  of  risks  to  the  patient  is  inherent  to  surgery  and  the  surgical  process,  and 
is  not  relatable  or  attributable  to  the  suture  used  for  closure.  The  risks  of  surgery  as  delineated  in  this 
submission  far  outweigh  any  ADDED  risks  of  using  Mesh  Suture  for  closure  as  opposed  to  standard 
suture.  There  are  risks  of  the  use  of  a  permanent  suture  in  terms  of  delayed  infection. 
POTENTIAL  BENEFITS  TO  PARTICIPANTS 
Pre-clinical  testing  in  14  human-sized  pigs  shows  a  stronger  and  earlier  hold  of  tissues  of  using  Mesh 
Suture  in  comparison  to  standard  sutures.  While  these  are  potential  benefits,  the  actual  benefits  and 
risks  to  the  patients  are  unknown. 
Analogous  "mesh  sutured  repairs"  in  500  humans  have  been  performed  for  over  3  years  at 
Northwestern  Memorial  Hospital,  Walter  Reed,  Ohio  State,  Brown  University,  Memorial  Sloane 
Kettering,  as  well  as  other  American  hospitals  without  any  unexpected  outcomes  different  than  that 
expected  for  standard  suture.  The  results  of  these  patients  treated  have  been  presented  locally, 
nationally,  and  internationally  to  large  audiences  of  surgeons  without  any  voiced  concerns. 
VULNERABLE  POPULATIONS 
See  above.  Polypropylene  is  a  well-established  suture  material  and  is  well-documented  in  the  use  in 
children  as  having  an  excellent  safety  profile.  Therefore,  its  use  in  this  study  protocol  is  acceptable.  It 
will  not  be  used  in  pregnant  women  and  in  infants  under  1  year. 
COMMUNITY-BASED  PARTICIPATORY  RESEARCH 
Not  applicable. 
SHARING  OF  RESULTS  WITH  PARTICIPANTS 
Will  be  performed  one  (1)  year  after  surgery  as  requested  by  the  patient. 
SETTING 
The  study  will  occur  at  the  Wigmore  Clinic  and  Arabkir  Joint  Medical  Center  in  Yerevan,  Armenia. 
RESOURCES  AVAILABLE 
Dr.  Koloyan  is  an  established  orthopedic  surgeon  and  has  the  necessary  time  and  expertise  to 
perform  this  clinical  trial,  aided  by  his  staff. 
PRIOR  APPROVALS 
None 
RECRUITMENT  METHODS 
Recruitment  will  be  through  the  clinic  of  Dr.  Koloyan. 
NUMBER  OF  LOCAL  PARTICIPANTS 
It  is  anticipated  that  up  to  100  patients  will  need  to  be  consented  preoperatively  to  have 80 
patients  who  will  have  the  potential  to  have  an  internal  mesh  suture  closure. 
 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
CONFIDENTIALITY 
PROVISIONS  TO  PROTECT  THE  PRIVACY  INTERESTS  OF  PARTICIPANTS: 
The  issues  of  patient  privacy  will  be  identified  in  the  consent  form. 
 
OBSERVATION AND RECORDING OF RESULTS 
 
Will be performed by the PI and his designees based on the routing performance of clinical practice. Superficial 
infection will be defined as the use of oral antibiotics for erythema that is more consistent with a bacterial process 
than with other explanations including pressure induced erythema, allergic reactions of the skin, or irritation from 
skin sutures.  A deep infection is defined as purulent drainage from the wound requiring an opening of the skin by 
the surgeon, a return to the operating room for drainage or wounds, and/or cultures from internal structures 
consistent with an infection.  Hematoma is defined as a collection of blood as the primary cause of a lack of 
appropriate wound healing, and a hematoma with secondary infection of the clot is also defined as a hematoma. 
A seroma is defined as clear fluid found underneath an intact incision or draining through a wound as the primary 
cause of a lack of appropriate wound healing.  A delayed sinus is defined as a area of a previously healed incision 
that leads to the Duramesh knot or filament that does not resolve with antibiotics, or requires an opening of the 
wound and Duramesh removal for resolution. 
 
ADVERSE EVENTS 
 
The documentation and reporting of all adverse events as per ISO/DIS 14155:2018(E) has been agreed to by the 
PI and sponsor and a signed document to this effect was created on June 20, 2018.  For the protection and benefit 
of patients, it is agreed that Dr. Koloyan will regularly communicate with the EIC.  All adverse events will be 
categorized according to ISO/DIS 14155: 2018 guidelines.  Any question regarding categorization will be reviewed 
by the data monitoring committee, made up of the members of the Wigmore Clinic IEC and chaired by Dr. Davit 
Abrahamyan, as well as outside reviewer Dr. Jonah Stulberg, Assistant Professor of Surgery at Northwestern 
Feinberg School of Medicine.    
 
COMPENSATION  FOR  RESEARCH-RELATED  INJURY 
The  use  of  a  suture  for  closure  of  deep  internal  tissues  is  within  the  standard  of  care,  and  there  are 
risks  of  infection,  need  for  repeat  surgery,  wounds,  and  delayed  infection  as  there  are  with  any 
surgical  suture.  It  is  not  thought  that  closure  with  a  Mesh  Suture  will  significantly  change  those  risks. 
Therefore,  there  will  be  no  compensation  for  research  related  injury.  However,  in  the  case  of 
postoperative  complications  related  to  the  Mesh  Suture  within  the  course  of  the  study  (1  year  after  the 
surgery  with  Mesh  Suture),  Dr.  Koloyan  will  perform  the  revision  surgery  free  of  charge. 
ADDED  ECONOMIC  BURDEN  TO  PARTICIPANTS 
None.  There  are  costs  of  surgery  and  postoperative  follow-up  that  are  unchanged  with  either  using  or 
not  using  the  Mesh  Suture. 
CONSENT  PROCESS 
The  consent  will  be  obtained  by  the  attending  surgeon,  or  by  the  study  coordinator.  This  will  occur 
preferably  in  the  clinical  office  of  the  attending,  but  also  in  the  preoperative  holding  area  before 
surgery.  We  expect  the  consent  process  to  take  10  minutes.  Suture  examples  will  be  shown  to  the 

 
patient.  Steps  taken  to  minimize  coercion  or  influence  will  be  contained  in  the  consent  form.  Consent 
will  be  obtained  by  native  Armenian  speakers. 
All  patients  who  meet  inclusion  criteria  and  who  do  not  have  exclusion  criteria  will  be  approached  for 
consent,  so  long  as  their  legal  guardian  or  legal  representative  is  present  and  consents  to  the 
orthopedic  procedure. 
PROCESS  TO  DOCUMENT  CONSENT  IN  WRITING 
The  process  to  document  consent  and  re-consent  in  writing  will  be  done  as  follows,  per  GCP 
guidelines:  the  consent  form  will  be  signed  and  personally  dated  by  the  participant  and/or  the  legal 
representative/guardian  and  by  the  person  who  conducted  the  consent  prior  to  any  study  procedures. 
A  signed  copy  of  the  consent  form  will  be  given  to  the  participant  or  the  legal  representative.  This 
process  will  be  documented  in  the  subject  source  documents. 
DRUGS  OR  DEVICES 
Three  different  sizes  of  Mesh  Suture,  namely  2-0,  0  and  Number  2,  will  be  under  the  control  of  the 
study  coordinator,  and  will  be  disbursed  in  the  operating  room  at  the  time  of  the  procedure.  The  study 
coordinator  will  fill  out  the  necessary  patient  data  form  at  that  time.   For traceability, lot number and 
expiration date for finished and packaged suture will be recorded. The sutures will be locked in a cabinet in the 
operating room with keys controlled by Drs. Koloyan and Abrahamian. They are labelled "For investigational use 
only".
 
 
 
 
 
 
 
 
 
 

 
 
 
STUDY PARTICIPANTS 
Dr. Garen Koloyan is head of the Wigmore Clinic and the PI for the study.  He completed medical school 
at the Tver State Medical University in Russia, where he received a medical degree.  He  completed 
his training in Traumatology and Orthopedics, and did fellowships both in Toronto at the Hospital for 
Sick Chidldren and the Shriner’s Hospital for Crippled Children in Portland Oregon.  He followed this 
with being Staff physician at the Insitution of Traumatology and Orthopedics in Yerevan, followed by a 
position as Chief of Pediatric  Orthopedic Surgery at the same institution.    From 2007 until now, he 
was head of pediatric trauma and orthopedics at the “Arabkir” Joint Medical Center in Yerevan.  In 
2017, he became the head of the Pediatric Orthopedic Service at the Wigmore Clinic in Yerevan.  He 
has  over 89 published articles, abstracts, and publications. 
 
Dr. Gregory Dumanian is the sponsor of the project and is the Science Officer for the Mesh Suture 
Co.  He is also the Chief of Plastic Surgery at the Northwestern Memorial Hospital.  He studied 
medicine at the University of Chicago, and graduated in 1987.  He studied surgery at the 
Massachusetts General Hospital, plastic surgery at the University of Pittsburgh, and hand surgery at 
the Curtis Hand Center.  He has over 140 publications, and has served as visiting professor over 20 
times to various universities both nationally and internationally.  He submitted his patent for a mesh 
suture in 2012.   
 
The Wigmore Clinic 
 
Wigmore Clinic is a modern medical center, which offers wide range of inpatient and outpatient services 
in orthopedics, sport medicine, spine surgery, vascular surgery, pediatrics, dentistry and interventional 
radiology. The Clinic was founded in 2017. The clinic’s facility is designed specifically to provide 
maximum comfortability and highest possible standards of care. Wigmore is a dynamic and rapidly 
growing medical center that has a commitment to evidence based clinical practice. Being affiliated with 
Yerevan State Medical University the clinic is involved in education and academic research. The clinic 
has a mission to build a culture of effective teamwork and quality: ensuring safe and patient focused 
care across all departments of the organization. Wigmore Clinic’s values are: commitment to continual 
improvement, high moral and professional standards, trust, respect and transparency. 
The advantage of Wigmore Clinic is the coordinated care in teams of experts, who are working to achieve 
the best results in treatment. Most of the leading surgeons of the hospital were trained in USA and 
Europe and created the wide network with medical specialists from these countries, who support the 
clinic in continual education and management of the most complicated cases. 
 
 
 

 
 
 
Arabkir Medical Center 
               “Arabkir” Joint Medical Center – Institute of Child and Adolescent Health (Arabkir JMC) is the largest 
pediatric hospital in Armenia, which realizes large-scale medical activities. The center provides medical 
services, including prevention, diagnostics and treatment of different child diseases, follow-up services 
for children with chronic urological and surgical, gastroenterological problems as well as with bronchial 
asthma, epilepsy, diabetes and hepatology, orthopedics, nephrology, endocrinology-related diseases, 
psycho-social and rehabilitation services. 
              “Arabkir” JMC also provides services for emergency cases and a number of services for adults in the 
fields of urology and general surgery, nephrology and kidney transplantation, laboratory diagnostics. As 
a multidisciplinary medical structure, Arabkir JMC provides medical assistance and care to thousands 
of children every year. The Service of Trauma and Orthopedics (STO) has a long history of providing 
high quality care to patients with musculoskeletal disorders. It is one of the leading departments not only 
in Armenia, but in the region. Many patients from neighbor countries such as Georgia, Russia, Ukraine, 
and Iran come to this Service for surgical treatment and rehabilitation. The hospital has several Child 
Development and Rehabilitation Centers function in different regions of Armenia.  
 
TRACEABILITY 
 
Lot number, reference number, and date of expiration will be recorded for each case.  In the event of 
need for follow-up of patients depending on information from the sponsor, it will be the responsibility 
of the PI to reach out and communicate with the patients in terms of need for follow-up, increased 
monitoring, and even surgery for addressing of the issue. 
 
LIABILITY 
 
As is the custom for clinics and surgeons in Armenia, neither the Wigmore Clinic nor Dr. Koloyan 
carry malpractice insurance.   
 
MISSING DATA 
 
It is the responsibility of the PI to accurately and completely fill out the CRF.  Missing data will be 
analyzed by the data monitoring committee and completed with assistance of the PI.  Follow-up either 
in person at the Wigmore Clinic or by telephone is the responsibility of the PI. 
 
DATA FROM THE MEDICAL RECORD 
 
All patients in this study will grant approval for the appropriate aspects of their medical record  
(including the operative report, photographic documentation, x-rays, laboratory findings, culture 
reports, and other pertinent information to be included in the Clinical Evaluation Trial.  Organizations 

 
that may inspect and copy the medical chart include the IRB and other representatives of this 
institution, government agencies such as the US Food and Drug Administration (FDA) and other 
regulatory authorities in other countries including the European Union; and the study sponsor Mesh 
Suture Inc.  The sponsor, monitors, auditors, the US Office for Human Research Protections (OHRP), 
the US FDA, as well as other government organizations may be granted direct access to the medical 
record to conduct and oversee the research.   
 
DEVIATIONS FROM PROTOCOL 
 
Any deviation from the protocol judged minor will be documented by the PI and judged whether the 
patient and outcome will be included in the final report.  Any deviation from the protocol judged major 
including will be communicated immediately with the data monitoring committee for resolution. 
 
 FINAL REPORT 
 
A final report of data will be provided by the PI to the sponsor.  This will include an evaluation of all 
primary and secondary endpoints. Efforts will be made to obtain long term follow up either by office 
visits at the Wigmore Clinic, and/or telephonic interviews of subjects.  Duramesh will be analyzed in 
terms of the size used, the location placed (tendon, joint capsule), running or interrupted closure, 
surgeon satisfaction, and a qualitative report of issues of use of the suture. The appropriate statistical 
tests including t-tests for the comparison of groups will be employed for data analysis.   
 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
1. 
LITERATURE  REVIEW  OF  PRE-CLINICAL  TESTING 
 
1.1. 
Pre-clinical Rat  In-Vivo  Hernia Model using Mesh Suture Prototype
2 
 
1.1.1.  Objective 
Demonstrate  in  an  established  rat  hernia  model  a  novel  mesh  suture  prototype  would  have  decreased 
pull-through  in  comparison  to  standard  suture. 
 
1.1.2.  Methods 
Incisional  hernias  were  produced  in  N=30  rats  according  to  an  established  hernia  model.  The  rat  hernias 
were  randomized  to  repair  with  either  two  5-0  polypropylene  sutures  or  two  mid-weight  polypropylene 
mesh  sutures.  Standardized  photographs  were  taken  prior  to  repair  and  1  month  after  repair. 
Edge-detection  software  was  used  to  define  the  border  of  the  hernia  defect  and  calculate  the  defect 
area.  Histology  was  performed  on  all  mesh  suture  specimens,  with  in-growth  graded  according  to  the 
ASTM  4-point  scale. 
 
1.1.3.  Results 
 
Table  1:  Results  from  Rat  Study 
 
Study  Endpoint 
Mesh
  
Suture
 
Prototype 
Conventional 
Suture 
 
Randomization  Assignment,  N 
17 
13 
 
Pulled-Through,  n  (%) 
0  /  34  (0) 
17  /  26  (65) 
 
Mean  Area  of  Recurrent  Defects 
Following  Repair,  mm
2 
178
 
267 
 
Change  in  Defect  Area,  % 
57.4%  Reduction 
10.1%  Increase 
 
ASTM  4-Point  Scale 
Excellent
  
(ASTM3)
  
fibro-collagenous
 
in-growth  in  13/17  specimens 
Good  (ASTM2)  in-growth 
in  4/13  suture  specimens 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure  1:  Rat  hernia  repair  data 
 

 
2 Souza  JM,  Dumanian  ZP,  Gurjala  AN,  Dumanian  GA.  In  vivo  evaluation  of  a  novel  mesh  suture  design  for  abdominal  wall  closure.  Plast 
Reconstr  Surg.  2015;135:  322e. 
Wigmore Clinic/Arabkir  JMC  30  June  2018 
Page 8  of  17 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
 
Suture  type 
Defect 
Area 
Pre- 
Repair 
Sutured 
Closure 
Post- 
Repair 
Defect 
Area 
 
 
 
Mesh  Suture 
Prototype 
 
 
 
 
 
 
 
 
Control  Suture 
 
 
 
 
Figure  2:  Rat  hernia  repair  images 
1.1.4.  Conclusion 
The  Mesh  Suture  had  improved  resistance  to  device  pull-through  compared  to  conventional 
polypropylene  sutures  in  this  30-day  rat  hernia  model.  The  design  elements  of  Mesh  Suture  may  prevent 
early  hernia  repair  failure  by  more  evenly  distributing  distracting  forces  at  the  device-tissue  interface. 
Tissue  incorporation  of  the  device  itself  was  documented  and  may  play  a  role  in  decreased  pull-through. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
1.2. 
Pre-clinical  Porcine  In  Vivo  Animal  Study  using  a  Mesh  Suture  Prototype
3 
 
1.2.1.  Objective 
Characterize  Ultimate  Tensile  Strength  (UTS)  of  porcine  abdominal  wall  closures  at  8  days  using  a 
1.7  mm  Mesh  Suture  in  comparison  to  standard  suture. 
 
1.2.2.  Summary 
This  study  was  published  in  the  British  Journal  of  Surgery  and  utilized  93  kg  pigs  in  a  clinically 
relevant  and  realistic  laparotomy  closure  model.  A  1.7  mm  Mesh  Suture  prototype  was  compared  to 
0-polypropylene  for  strength  of  closure  at  8  days  after  implantation. 
 
1.2.3.  Background 
Laparotomy  closure  failure  leads  to  incisional  hernia  formation  in  up  to  23%  of  patients  requiring  the 
risk,  expense,  and  discomfort  of  a  second  surgery. 
 
1.2.4.  Methods 
In  Vitro  –  A  1.7  mm  Mesh  Suture  and  a  0-polypropylene  suture  were  tested  for  resistance  to  pull- 
through  in  ballistics  gel. 
In  Vivo  –  Closure  of  midline  laparotomy  segments  was  performed,  alternating  between  2  mm  Mesh 
Suture  prototype  and  0-polypropylene  in  N=12  female  swine. 
Tissue  segments  were  subsequently  subjected  to  mechanical  testing  at  8  days  in  N=10  animals,  and 
histologic  testing  for  N=1  pig  at  3  months  and  N=1  pig  at  6  months. 
The  1.7  mm  Mesh  Suture  prototype  was  designed  to  have  tensile  characteristics  similar  to  USP  size 
0-polypropylene  suture  –  used  clinically  in  human  abdominal  wall  closures.  As  the  two  devices  being 
compared  have  similar  tensile  strength,  any  differences  found  in  the  UTS  of  the  closure  are  due  to 
biologic  healing  and  not  due  to  the  strength  of  the  device  itself. 
 
1.2.5.  In  Vitro  Results 
The  data  in  the  Figure  3  below  shows  that  the  1.7  mm  Mesh  Suture  prototype  device  closures  were 
significantly  stronger  at  8  days  than  0-polypropylene  closures. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure  3:  Porcine  force/elongation  curve  data.  Force  and  elongation  comparison  of  explanted  porcine 
abdominal  wall  segments  with  either  Mesh  Suture  (n=16)  or  0-polypropylene  suture  (n=18)  8  days  after  closure. 
 
3 Dumanian  GA,  Tulaimat  A,  Dumanian  ZP. 
Experimental  Study  of  the  Characteristics  of  a  Novel  Mesh  Suture.  Br  J  Surg. 
2015;102(10):1285-92. 
 
 

 
Table  2:  Results  from  Porcine  Model  at  8  Days 
Histology Testing 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
1.2.6.  In  Vivo  Results 
Ultimate  Tensile Strength  (UTS) 
The  UTS  for  repaired  linea  alba  was  tested  at  8  days.  Failure  was  defined  as  the  onset  of  muscle 
tearing.  The  UTS  was  defined  as  the  highest  force  registered  by  the  tensiometer.  Elongation  was 
defined  as  the  distance  that  the  tissue  was  stretched  from  the  point  where  force  rose  above  its 
baseline  measurement  until  the  UTS. 
Work  to  UTS  was  computed  as  the  product  of  force  and  elongation.  Elasticity  is  defined  as  the  force 
required  to  extend  a  material  a  unit  distance.  The  elasticity  for  specimens  was  obtained  from  the 
slope  of  the  linear  portion  of  the  force-elongation  curves. 
As  shown  in  Table  2,  the  ultimate  tensile  strength  was  double  and  the  work  to  failure  (work  is  force 
times  distance)  was  triple  that  of  0-polypropylene  suture. 
 
 
 
 
 
 
 
 
 
Histology  testing  at  8  days  showed  complete  tissue  integration  of  the  mesh  suture  prototype. 
Histology  at  90  and  180  days  demonstrated  a  biocompatible  tissue  response  and  decreased  device 
pull-through  in  comparison  to  standard  0-polypropylene  suture.  Small  hernia  defects  were  seen  with 
the  0-polypropylene  suture  closures  but  not  in  the  mesh  suture  closures.  Relevant  photographs  of  the 
porcine  tissues  post-op  3  months  with  polypropylene  suture  and  the  mesh  suture  prototype  are  shown 
in  Figure  4.  The  polypropylene  segment  on  the  right  has  evidence  of  the  suture  cutting  the  fascia, 
while  the  entry  points  of  the  mesh  suture  prototype  into  the  tissues  are  clean  and  without  damage. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure  4:  Porcine  abdominal  wall  segments  demonstrating  suture  pull-through  with  Mesh 
Suture  and  standard  suture 
1.2.7.  Conclusion 
 
A  Mesh  Suture  reliably  closed  porcine  laparotomies  in  human-sized  animals.  Tensile  characteristics 
showed  adequate  strength  of  sutured  segments,  and  histology  demonstrated  a  characteristic  tissue 
reaction  for  a  macroporous  implant. 
 
 
 
Study  Endpoint 
Conventional 
Suture 
Mesh 
Suture 
p-value 
Ultimate  Tensile  Strength  (N) 
160 
320 
p  <  0.001 
Work  to  Failure  (J) 
7 
25 
p  <  0.001 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
1.3. 
Pre-clinical  Dog  Cadaveric  Shoulder  Study  using  Mesh  Suture  Prototype
4 
1.3.1.  Objective 
Characterize  UTS  of  rotator  cuff  repairs,  comparing  a  Mesh  Suture  prototype  to  2  commonly  used  sutures. 
1.3.2.  Summary 
This  independent  study  was  performed  in  the  Department  of  Orthopedics  at  the  Mayo  Clinic  in  72 
cadaveric  dog  shoulders. 
1.3.3.  Background 
Surgical  repair  is  a  common  treatment  for  rotator  cuff  tear;  however,  the  re-tear  rate  is  high.  A  high 
degree  of  suture  repair  strength  is  important  to  ensure  rotator  cuff  integrity  for  healing.  The  purpose  of 
this  study  was  to  compare  the  mechanical  performance  of  rotator  cuffs  repaired  with  a  Mesh  Suture 
versus  traditional  polydioxanone  suture  II  and  FiberWire  sutures  in  a  canine  in  vitro  model. 
1.3.4.  Methods 
Two  suture  techniques  –  simple  interrupted  sutures  and  two-row  suture  bridge  –  were  used  to 
reconnect  the  infraspinatus  tendon  to  the  greater  tuberosity,  using  three  different  suture  types:  1.7 
mm  diameter  Mesh  Suture  prototype,  polydioxanone  suture  II,  or  FiberWire.  Shoulders  were  loaded  to 
failure  under  displacement  control  at  a  rate  of  20  mm/min.  Failure  load  was  compared  between  suture 
types  and  techniques. 
1.3.5.  Results 
Ultimate  failure  load  was  signiﬁcantly  higher  in  the  specimens  repaired  with  Mesh  Suture  than  with 
polydioxanone  suture  II  or  FiberWire,  regardless  of  suture  technique. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure  5:  Dog  shoulder  repairs  with  1.7  mm  Mesh  Suture  prototype  and  standard  sutures: 
Ultimate  failure  load  of  repaired  tendon–bone  interfaces.  Solid  lines  indicate  a  signiﬁcant  difference  between  two 
groups  in  the  simple  interrupted  suture  technique  and  dotted  lines  indicate  a  signiﬁcant  difference  between  two 
groups  in  the  suture  bridge  repair  technique  (p  <  0.05). 
1.3.6.  Summary 
Based  on  the  biomechanical  ﬁndings,  rotator  cuff  repair  with  the  Mesh  Suture  might  provide  superior 
initial  strength  against  failure  compared  with  the  traditional  polydioxanone  suture  II  or  FiberWire 
sutures.  Use  of  the  Mesh  Suture  may  provide  increased  initial  ﬁxation  strength  and  decrease  gap 
formation,  which  could  result  in  improved  healing  and  lower  re-tear  rates  following  rotator  cuff  repair. 
 
 
4 Zhang  T,  Hatta  T,  Thoreson  AR,  Lu  CC,  Steinmann  SP,  Moran  SL,  Zhao  C.  Rotator  cuff  repair  with  a  novel  mesh  suture:  an  ex  vivo 
assessment  of  mechanical  properties.  J  Orthop  Res.  2018;36(3):987-992. 
 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
1.4. 
Pre-clinical Human Cadaveric Finger Tendon Study using 2-0  DURAMESH5 
1.4.1.  Objective 
Characterize  UTS  of  repaired  cadaveric  human  finger  tendons,  comparing  DURAMESH  to  two 
commonly  used  sutures. 
1.4.2.  Summary 
This  study  was  performed  at  the  Department  of  Orthopedics  at  Loyola  University  and  the  Division  of 
Plastic  Surgery  at  Northwestern. 
1.4.3.  Background 
Human  finger  flexor  tendon  repairs  are  known  to  be  challenging  procedures  with  high  complication 
rates  including  adhesion  formation,  stiffness,  and  repair  failure.  While  early  motion  protocols  have 
demonstrated  reduced  adhesion  formation  and  improved  function,  they  place  the  repair  site  under 
tension  and  at  risk  of  rupture.  Conventional  suture  repairs,  when  stressed,  fail  as  the  suture  cuts 
through  the  intervening  tissue  –  known  as  “suture  pull-through”.  The  purpose  of  this  study  is  to 
compare  the  biomechanical  properties  of  flexor  tendon  repairs  using  a  novel  mesh  suture  device  to 
traditional  suture  repairs. 
1.4.4.  Methods 
Two  suture  techniques  –  simple  interrupted  sutures  and  two-row  suture  bridge  –  were  used  to 
reconnect  the  infraspinatus  tendon  to  the  greater  tuberosity  in  human  cadaveric  samples,  using  three 
different  suture  types:  2-0  DURAMESH,  polydioxanone  suture  II,  or  FiberWire.  Shoulders  were  loaded 
to  failure  under  displacement  control  at  a  rate  of  20  mm/min.  Failure  load  was  compared  between 
suture  types  and  techniques.  Sixty  human  cadaveric  flexor  digitorum  profundus  tendons  were 
harvested  and  assigned  to  one  of  three  suture  repair  groups:  3-0  and  4-0  braided  poly-blend  suture 
(FiberWire,  Arthrex,  Inc,  Naples,  FL),  or  1  mm  diameter  mesh  suture;  all  tendons  were  repaired  using 
a  4-strand  core  cruciate  suture  configuration.  Each  tendon  repair  underwent  either  linear  loading  or 
cyclic  loading  until  failure.  Outcome  measures  included  yield  strength,  ultimate  strength,  the  number 
of  cycles  and  load  required  to  achieve  1  mm  and  2  mm  gap  formation,  and  failure. 
1.4.5.  Results 
Mesh  suture  repairs  had  significantly  higher  yield  and  ultimate  force  values  when  compared  to  3-0 
and  4-0  braided  poly-blend  suture  repairs  under  linear  testing.  The  average  force  required  to  produce 
repair  gaps  was  significantly  higher  in  mesh  suture  repairs  compared  to  conventional  suture.  Mesh 
suture  repairs  endured  a  significantly  greater  number  of  cycles  and  force  applied  before  failure 
compared  to  both  3-0  and  4-0  conventional  suture. 
1.4.6.  Summary 
This  biomechanical  study  of  flexor  tendon  repairs  using  a  novel  mesh  suture  reveals  significant 
increases  in  average  yield  strength,  ultimate  strength,  and  average  force  required  for  gap  formation 
and  repair  failure  with  mesh  suture  repairs  compared  to  conventional  suture  cohorts.  Such  findings 
could  allow  for  earlier  mobilization,  decreased  adhesion  formation,  and  lower  rupture  rates  after  flexor 
tendon  repairs. 
 
5 Wallace  SA,  Mioton  LM,  Havey  RM,  Muriuki  MG,  Ko  JH.  Biomechanical  properties  of  a  novel  mesh  suture  in  a  cadaveric  flexor  tendon 
repair  model.  Submitted for  publication to  J  Hand  Surg. 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure  6:  Cyclic  and  linear  testing  of  2-0  DURAMESH  and  Standard  Sutures  for  repairing 
human  cadaveric  finger  flexor  tendons 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
2. 
SUPPORTING  CLINICAL  LITERATURE  STUDIES 
Years  ago,  Dr.  Dumanian  developed  a  new  closure  technique  for  human  abdominal  wall  defects. 
Strips  of  macroporous  polypropylene  mesh  were  cut  from  a  sheet  of  mesh  and  used  as  a  suture  for 
soft  tissue  approximation.  This  clinical  concept  of  utilizing  strips  of  polypropylene  mesh  as  a  suture 
led 
to 
the 
Improved 
Suture 
Patent 
(US 
2013/0226232 
A1), 
Advanced 
Suture 
Inc. 
(www.meshsuture.com),  and  development  of  the  DURAMESH,  the  subject  of  this  510(k)  application. 
Mesh  strips  for  closure  of  abdominal  wall  defects  were  published  in  two  clinical  articles  attached  with  this 
510(k)  submission  as  a  supporting  clinical  study  to  the  concept  of  a  low  filament  size/high  surface  area 
closure.  Since  Dr.  Dumanian  first  reported  on  his  technique  for  Mesh  Sutured  Repairs  of  Abdominal  Wall 
Defects,  the  technique  has  gained  acceptance  by  the  surgical  community.  Mesh  Sutured  repairs  have 
been  used  successfully  in  hundreds  of  cases  at  numerous  institutions  including  Northwestern,  The  Ohio 
State  University,  Memorial  Sloan  Kettering,  the  University  of  Illinois  Chicago,  and  Walter  Reed.  The 
technique  was  recently  summarized  in  proceedings  from  an  international  hernia  prevention  symposium.
6 
 
 
2.1. 
Mesh  Sutured  Repairs  of  Abdominal  Wall  Defects
7 
2.1.1.  Background 
Planar  meshes  are  known  to  improve  outcomes  of  incisional  hernia  repair.  Planar  meshes  distribute 
forces  across  high  tension  closures  such  as  laparotomy  incisions.  Fibrous  ingrowth  between  and 
around  filaments  helps  increases  the  strength  of  the  repair.  However,  the  use  of  planar  mesh  is  not 
without  drawbacks,  due  to  the  increased  amount  of  foreign  material,  infections,  extrusions,  and  soft 
tissue  devascularization  to  place  the  devices. 
2.1.2.  Methods 
A  new  technique  for  abdominal  wall  closure  was  devised  that  uses  strips  of  mesh  as  sutures.  The 
mesh  strips  from  a  single  piece  of  Prolene  Soft  Mesh  (Ethicon,  Somerville  NJ)  were  cut  20-mm  wide 
along  the  blue  lines  and  passed  through  the  tissues  with  a  clamp.  The  mesh  strips  are  tied  with  knots 
to  achieve  tissue  apposition.  This  technique  was  used  in  a  total  of  107  patients  for  a  wide  range  of 
abdominal  wall  defects. 
2.1.3.  Results 
Of  the  107  patients,  76  had  preoperative  hernias,  and  the  mean  hernia  width  by  CT  scan  for  those 
with  scans  was  9.1  cm.  The  remaining  31  patients  had  abdominal  closures  with  mesh  strips  due  to 
non-midline  defects,  for  the  desire  to  have  a  small  procedure  and  avoid  planar  mesh,  or  for  patients 
with  open  abdomens  after  trauma.  Forty-nine  surgical  fields  were  clean-contaminated,  contaminated, 
or  dirty.  Five  patients  had  infections  within  the  first  30  days.  Only  one  knot  was  removed  as  an  office 
procedure.  Mean  follow-up  at  234  days  revealed  4  recurrent  hernias. 
2.1.4.  Conclusions 
Lessons  learned  from  these  patients  include: 
 
6 Harris  HW,  Hope  WH,  Adrales  G,  Andersen  DK,  Deerenberg  EB,  Diener  H,  Dumanian  G,  East  B,  Fischer  JP,  Urena  MAG,  Gibeily  GJ, 
Hansson  BM,  Hernandez-Granados  P,  Hiles  MC,  Jeekel  J,  Levinson  H,  Lopez-Cano  M,  Muysoms  F,  Pereira  JA,  Prudhomme  M, 
Ramaswamy  A,  Stabilini  C,  Torkington  J,  Valverde  S,  Young  DM.  Contemporary  concepts  in  hernia  prevention:  Selected  proceedings 
from  the 2017  International  symposium  on prevention of  incisional  hernias.  Surgery.  2018;164(2):319-326. 
7 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(9):e1060. 
 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
a.  Despite  placing  these  strips  into  contaminated  fields  in  49  patients,  there  were  few  knots  that 
needed  to  be  removed,  and  no  patient  returned  to  the  operating  room  for  the  removal  of  a  deep 
infected  knot. 
b.  The  overall  surgical  site  occurrence  (SSO)  and  surgical  site  infection  (SSI)  rate  was  low 
considering  the  complexity  of  the  patient  population 
c.  The  overall  amount  of  foreign  material  in  comparison  to  the  use  of  planar  mesh  is  much  reduced. 
Maintenance  of  tissue  vascularity  and  the  rapid  incorporation  of  the  mesh  strips  was  postulated  to 
be  a  reason  for  the  favorable  outcomes. 
d.  Bowel  adhesions  were  not  a  clinical  problem  seen  in  these  patients. 
e.  In  patients  with  open  wounds  in  whom  both  0-polypropylene  sutures  and  mesh  strips  were  used, 
the  sutures  would  have  to  be  removed,  while  the  strips  granulated  over  and  closed  with  minimal 
wound  care.  Improved  biocompatibility  was  theorized  to  be  due  to  the  smaller  diameter  filaments 
that  comprise  the  mesh  strips  (100  μm)  as  opposed  to  the  0-polypropylene  sutures  (400  μm). 
 
 
2.2. 
Mesh  Sutured  Repairs  of  Contaminated  Incisional  Hernias
8 
2.2.1.  Background 
There  is  no  surgical  consensus  for  the  closure  of  an  incisional  hernia  in  the  presence  of 
contamination.  While  planar  meshes  can  be  successfully  used,  any  infection  or  need  for  re-operative 
bowel  surgery  requires  a  sizeable  procedure  to  remove  the  sheet  of  mesh.  Bioprosthetic  meshes  do 
not  seem  to  provide  durable  hernia  closure  and  are  expensive.  In  this  retrospective  study,  the  safety 
and  efficacy  of  using  strips  of  mesh  as  sutures  was  investigated. 
2.2.2.  Methods 
48  patients  with  contaminated  hernias  5-cm  wide  or  greater  by  CT  scan  were  closed  with  strips  of 
mesh.  Surgical  site  occurrence  (SSO),  surgical  site  infections  (SSI),  and  hernia  recurrence  were 
compared  to  similar  patient  series  reported  in  the  literature. 
2.2.3.  Results 
Of  the  48  patients,  20  had  clean-contaminated  wounds,  16  had  contaminated  wounds,  and  12  were 
infected.  69%  of  the  patients  underwent  an  anterior  perforator  sparing  components  release  for  hernias 
that  averaged  10.5  cm  transversely  (range  5  cme25  cm).  SSO  occurred  in  27%  of  patients  while  SSI 
was  19%.  There  were  no  fistulas  or  delayed  suture  sinuses.  With  a  mean  follow-up  of  almost  12 
months,  3  midline  hernias  recurred  (6%).  In  these  same  patients,  three  parastomal  hernias  repaired 
with  mesh  sutures  failed  out  of  4  attempted  for  a  total  failure  rate  of  13%. 
2.2.4.  Conclusions 
Closure  of  contaminated  incisional  hernias  is  not  only  possible  with  a  mesh  suture,  but  it  is  preferable 
when  compared  to  other  techniques  in  the  literature  including  simple  suture  closure,  planar  prosthetic 
mesh,  and  planar  bioprosthetic  mesh.  Direct  closure  of  the  abdominal  wall  maintains  tissue 
vascularity,  decreases  the  total  amount  of  prosthetic  material  used,  saves  tissue  planes  for  another 
day,  can  be  performed  by  surgeons  of  all  disciplines,  and  is  rapid. 
 
8 Dumanian  GA,  Lanier  ST,  Souza  JM,  Young  MW,  Boller  AM,  Mueller  KH,  Halverson  AL,  McGee  MF,  Stulberg  JJ.  Mesh  sutured  repairs 
of  contaminated incisional  hernias.  Am  J  Surg.  2018;216(2):267-273. 

 
CLINICAL  STUDY  PROTOCOL: Mesh  Suture 
 
Table  3:  Data  of  Mesh  Sutured  Closures  of  Contaminated  Abdominal  Hernias