Prospective Randomized Trial of Stratafix vs. Vicryl on Operating Room Time and Wound Closure Time in Total Hip Arthroplasty.
Phase: NA
Conditions: Wound; Hip
Sponsor: The Cleveland Clinic

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Study Protocol Title: Prospective randomized trial of Stratafix vs. Vicryl on operating room 
time and wound closure time in Total Hip Arthroplasty. 
 
 
Protocol Version: 2.0 
Protocol Date: 05/04/2018 
Principal Investigator: Dr. Viktor Krebs, Phone#: 216-445-3834, Email: krebsv@ccf.org 
Funding Sponsor: Johnson and Johnson, Somerville, New Jersey 
Project Contact:   
Christine Romanowski, MD, CCRA  
Sr. Clinical Project Manager  
Clinical Development  
ETHICON, Inc. a Johnson & Johnson Company  
P: 908-218-3156   F: 908-218-5490 Email: cromanow@its.jnj.com  
 
Regulatory Sponsor: 
This study is an Investigator Initiated research trial. Each study site will be considered its own 
regulatory sponsor and is responsible for internal data monitoring and any study reporting 
required by ClinicalTrials.gov. 
 
 
 
 
 
 
 
 
 
 
 

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Introduction: 
Total hip arthroplasty is an effective orthopedic procedure to improve function, correct 
gait, and alleviate symptoms of late-stage arthritis in patients who have failed non-operative 
management.  With constant introduction of various techniques for wound closure, assessment 
of closure times and outcomes will be a topic of marked importance.  
The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless 
Tissue Control suture device is a barbed suture that uses anchor technology to securely engage 
with the soft tissues while also eliminating the need for knots.  The anchors, or barbs, are 
pressed out of the device core or formed within the core in a geometric pattern and arranged in a 
tapered manner to allow the device to pass through tissue in the direction toward the needle 
during closure.  These knotless tissue control devices are deployed using a continuous 
technique, which we anticipate to be faster and more cost-effective than interrupted suturing. 
 
Background and Significance/Preliminary Studies: 
Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and 
deep tissue closures.[1], [2] In addition, barbed sutures have been shown to provide water-tight 
closure and wound strength comparable to or superior to closure with conventional sutures. 
Many comparative studies have been published contrasting barbed sutures to conventional 
closure techniques in multiple surgical fields. [3], [4] 
Various studies have evaluated the outcomes of different barbed suture devices, however 
there are no reports assessing the length of closure times using STRATAFIX (Ethicon, Johnson 
and Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during deep closure in 
total hip arthroplasty. Stephens et al. [5] performed a prospective randomized study of 500 total 
knee arthroplasty patients who received either barbed suture (250) or conventional sutures (250) 
for deep closure of the surgical wound. The mean operating time was significantly shorter in the 
barbed group as compared to conventional group (64.3 vs 68.1 minutes, p=<0.001). In a study 
of 80 TKA (61 barbed, 19 conventional deep sutures) and 54 THA patients (37 barbed, 17 
conventional deep sutures), Smith et al. [6] found significantly shorter closure time in the 
barbed suture group (16.78 vs. 26.5 minutes, p<0.001). One study reports one the use of Stratfix 
suture for intracorporeal suturing in myomectomy. Giampaolino et al. [7] performed a 
prospective randomized study on 47 patients and evaluated the mean operative time for 

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laparoscopic posterior myomectomy using Stratafix or conventional suture for intracorporeal 
suturing. There was a significant decrease in mean operative time associated with use of 
Stratafix suture as compared to conventional suture (66.3 vs 73 minutes, p=0.005). 
This prospective randomized single-center study will examine the outcomes, mainly 
closure time, of deep closure during total hip arthroplasty using the STRATAFIX Symmetric 
PDS Plus (Ethicon, Johnson and Johnson, Somerville, New Jersey) barbed suture compared to 
interrupted VICRYL suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).   
 
Study Design: 
In this prospective study examining the deep closure during total hip arthroplasty, active 
subjects will receive the STRATAFIX Symmetric PDS Plus (Ethicon, Johnson and Johnson, 
Somerville, New Jersey) suture while the control subjects will receive interrupted VICRYL 
suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).  Superficial closure will be the 
standard of care for both groups.   
The purpose of this study is to compare end points (see below): 
 The primary endpoint of the study will be closure time and operative time.   
 Secondary endpoints will examine: wound complications, costs comparison between the 
two techniques. 
Post-operatively, patients will be assessed at clinic visits at 6 weeks and 3 months.  At these 
time points, we will assess (Table 1):  
Table 1.  
REQUIRED STUDIES 
Pre-Op 
Intra-
operative 
6 week post-op 
3 month post-op 
Informed Consent 
x 
 
 
 
Length of surgery time 
 
x 
 
 
Length of closure time 
 
x 
 
 
Amount of suture material used 
 
x 
 
 
Surgeon experience level  
 
x 
 
 
Wound complications 
 
 
x 
x 
 
Methods 

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 A prospective randomized pilot study 
Sample 
 60 subjects for a pilot study 
Inclusion Criteria:  
1. Males and females, between the ages of 18 to 80 years at the time of signing the 
informed consent document. 
2. Understand and voluntarily sign an informed consent document prior to any study-
related assessments/procedures are conducted. 
3. Able to adhere to the study visit schedule and other protocol requirements. 
4. Able to fluently speak and understand the local language 
5. If female, is non-pregnant (negative pregnancy test results at the baseline/randomization 
visit) and non-lactating. 
6. End-stage osteoarthritis patients planning to undergo primary total hip arthroplasty 
7. BMI less than 40 kg/m2 
Exclusion Criteria: 
1. BMI greater than or equal to 40 kg/m2. 
2. History of known bleeding disorder.  
3. History of medical co-morbidity that may result in poor wound healing (i.e. diabetes 
mellitus, peripheral vascular disease). 
4. Patients <18 or >80 years of age.  
5. Patients who are prisoners.  
6. Mentally unable to sign informed consent. 
7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the 
patient to be withdrawn from the trial or would otherwise interfere with interpreting the 
results of the study. 
Screening and Recruitment: Informed Consent 
 
Informed consent will be obtained by one of the study coordinators/co-investigators 
during a clinical visit prior to procedure in the privacy of an examination room or an office.  
Patients will be informed about the study and inquired about their interest to participate. A 
consent document will be given and key parts of the research study will be explained in lay-
terms to the patient to ensure full understanding.  Any questions regarding the research study 

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will be answered at that time.  It will be emphasized that participation is voluntary.  Those 
patients who are willing to participate will be asked to sign the consent document along with the 
consenting researcher.  A signed copy of the consent document will be handed to the patient 
while another copy is kept in their study file.   
 
In the event that an approach prior to the day of surgery is not feasible, same day of 
procedure consenting will be attempted. Patients will be contacted by telephone (see phone 
script), and those interested in participating in the study will be informed about what is 
involved, the follow-up visit, and that participation in the study is strictly voluntary, and will not 
affect the scheduling of their upcoming surgery. If the patient is interested in participating, the 
patient can be either mailed or emailed a copy of the informed consent form, and then 
arrangements will be made to complete the informed consent process prior to the patient being 
taken back into the preoperative area on the day of surgery. The patient will be asked to come to 
the hospital on the day of surgery earlier than the time they were told to arrive by surgical 
scheduling in order to make sure there will be adequate time to discuss the study, including 
what is involved, risks, benefits, and alternatives. We do not believe that an eventual approach 
on the same day of procedure would represent an added stress for the patient or delay the start 
of the procedure.  Similar to obtaining informed consent prior to the day of procedure, the 
process will occur in a private setting with ample time to discuss the study’s implications, risks, 
benefits, and alternatives. No procedures or tests will be conducted on the screening visit after 
consenting the patient. 
 
Randomization procedures: 
Patients will be randomized to either arm of the study as follows: sealed envelopes in a random 
order will be used to place study participants in either the barbed suture arm or in the traditional 
suture arm of the study. Patients will be randomized in a one to one ratio. At the 
commencement of each arthroplasty, a random envelope will be drawn which dictated the type 
of suture to be used, thus blinding the patients to the type of suture they received. 
 
Research Procedure:  

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A standard posterior approach will be performed by the participating surgeons. For the 
traditional closure (control group), Abductor muscles  will be  repaired using Ethibond, and the 
deep fascia will be repaired using interrupted number 1 braided absorbable sutures (Vicryl, 
Ethicon; Johnson & Johnson, Somerville, NJ). The subcutaneous fat layer will be then closed 
with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by 
closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with 
inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-
strips and adhesive (See table 2).  
For the active arm of the study, wound closure will be performed in this fashion: 
abductor muscles will be repaired using Ethibond 2-0 (Excel MX69G), and STRATIFIX 
symmetric PDS Plus #1 will be used to close the fascia. (See Table 2).  The subcutaneous fat 
layer will be then closed with simple interrupted knots using number 2-0 braided absorbable 
sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 
monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & 
Johnson) followed by the use of steri-strips and glue (See table 2).  
Closure with the unidirectional barbed suture involves starting at the upper end of the 
wound and proceeded distally. At the ends of the wounds, the suture is backstitched toward the 
midpoint for further reinforcement before bringing the needle out through the skin; the suture is 
then cut flush with the tissue at its free end. With each throw, the leading end of the suture is 
pulled with only enough tension to engage the barbs with the surrounding tissue, thereby locking 
the wound edges into approximation. As with the traditional closure and in concordance with our 
routine protocol, barbed closures were finished with skin steri-strips and adhesive. 
 
Table 2: Suture Type for Closure Following Total Hip Arthroplasty. 
Layer 
Control Group 
Active Group 
Muscle 
Ethibond 2-0 (Excel MX69G) 
Ethibond 2-0 (Excel MX69G) 
Fascia 
Vicryl #1 (J947H#1) 
STRATIFIX (SXPP1A04#1) 
Subcutaneous 
Vicryl 2.0 (J945H 2-0) 
Vicryl 2.0 (J945H 2-0) 
Subcuticular 
Monocryl 3.0 (Y496H) 
Monocryl 3.0 (Y496H) 

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Skin 
Steri-strips, glue (Standard of 
care) 
Steri-strips, glue (Standard of 
care) 
 
 
 
Patient Protection: 
 
All data collection sheets will be de-identified. All patients will be assigned a study ID. 
All data collected will be entered into Excel sheet and stored on Cleveland Clinic secure 
computers. Only members of the study team (listed on the IRB application) will have access to 
protected health information of patients included in this study.  
 
Safety Monitoring Plan 
Procedural safety will be documented in this study through patient and surgeon reported 
adverse events. AEs will be documented for all cases in this study. An Unanticipated Problem 
involving risks to participants or others is any event that (1) is unforeseen, (2) caused harm or 
placed a person at increased risk of harm, and (3) is related to the research procedures. 
An Adverse Event (AE) is any untoward or unfavorable medical occurrence, including 
any abnormal sign (for example, abnormal physical exam or laboratory finding), symptoms, or 
disease. Adverse events can encompass both physical and psychological harms. An Internal 
Adverse Event (AE) is an untoward medical occurrence, which occurs to participants in 
research conducted by Cleveland Clinic and/or Cleveland Clinic is the IRB of record. External 
Adverse Event (AE) is an untoward medical occurrence experienced by subjects enrolled at 
other institutions for the same study approved at Cleveland Clinic or a different study using the 
same study drug/device. A Serious Adverse Event (SAE) is any adverse experience that results 
in any of the following outcomes: 
 Death 
 A life-threatening experience 
 Inpatient hospitalization or prolongation of existing hospitalization 
 A persistent or significant disability/incapacity. 
 A congenital anomaly/birth defect 

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 Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered a serious adverse drug experience 
when, based upon appropriate medical judgment, they may jeopardize the patient 
or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
An Unexpected Adverse Event means any AE not previously known or included in the 
current Investigator’s Brochure, consent form or other risk information. 
Related/Possibly Related means there must be reasonable evidence to suggest the event was 
caused by the drug, device or investigational intervention. 
1. Internal Serious Adverse Events (events that occur to participants enrolled in 
research being conducted by Cleveland Clinic or when Cleveland Clinic is the IRB of record) 
must be promptly reported to the IRB using the IRB AE Report Form within10 working days 
from discovery/awareness which meet any of the following criteria as assessed by the PI/Co-I: 
a) Serious, Unexpected and Related/Possibly Related. 
b) AE’s determined to be occurring at a significantly higher frequency or severity than 
expected. 
 c) Other Unexpected AE’s, regardless of severity, that changes the risk benefit ratio of the 
study and results in changes to the Research Protocol or Informed Consent 
process/document. 
            All Internal SAEs are also reported at continuing review using the AE Summary Log. 
 2. External Serious Adverse Events (events experienced by subjects enrolled at other 
institutions for the same study approved at Cleveland Clinic or a different study using the same 
study device/drug) are reportable to the IRB using the IRB AE Report Form within 10 working 
days from discovery/awareness when: 
a. The External SAE report includes reasonable evidence as assessed by a central 
monitoring   entity [Coordinating or Statistical Center, or a Data Safety 
Monitoring Board (DSMB) or Data Monitoring Committee (DMC)] that the 
event is Serious, Unexpected, and Related/Possibly Related AND places the 
subjects or others at a greater risk of physical or psychological harm than was 
previously known or recognized. This will require a change in the protocol 
and/or consent document. 

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 b. External SAE reports provided by the Sponsor to the investigator indicating the 
event is Serious, Unexpected and Related/Possibly related but without reasonable 
evidence or DSMB/DMC determination of greater risk are not reportable to the 
IRB within the 10 day window. Without Sponsor evidence or assessment the 
implications of the event cannot be determined by the research team and 
therefore need not be reviewed. These SAE’ shall be placed on the AE Summary 
log to be submitted at the annual continuing renewal. 
3. DEATHS are to be reported to the IRB using the IRB AE Report Form according to the 
following guidelines: 
a) Internal Death: 
 Related/possibly related whether expected or unexpected– within 5 working days 
from discovery/awareness 
 Not related and expected – at time of continuing review 
 Not related and unexpected – at time of continuing review except cancer studies. 
 Cancer: Not related and unexpected within 10 working days from 
discovery/awareness 
b) External Death: 
Related/possibly related and unexpected – within 5 working days from 
discovery/awareness not related whether expected or unexpected – at time of 
continuing review related/possibly related and expected – at time of continuing 
review 
c) ALL Deaths are also reported at time of continuing review using the AE summary 
log. 
4. Non-serious Adverse events (Internal and External) that are both Related/Possibly 
related and unexpected are reported on the AE Summary Log at time of continuing review to 
assess trends. 
5. An IRB staff (a qualified, licensed practitioner assigned to this function by the IRB chair 
and IRB Executive Director) reviews Adverse Event Reports to determine whether they 
represent Unanticipated Problem Involving Risks to Participants or Others. Events that are 
assessed, by either the IRB Staff or Investigator, to place subjects or others at a greater risk of 
harm than was previously known or recognized, or changes the risk/benefit ratio of the study, or 

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requires a change in the protocol and/or consent document are referred to Full Board for review 
under Policy #70. Events that do not involve risk to Participants or Others or changes to the 
informed consent or protocol do not require further review. Investigators are informed of the 
determination and the IRB file is updated. 
6. The AE Summary Log is reviewed by the IRB at the time of continuing review to 
identify trends in frequency and severity which may impact subject safety. 
This study is an Investigator Initiated research trial. Each study site will be considered 
its own regulatory sponsor and is responsible for internal data monitoring and any study 
reporting required by ClinicalTrials.gov. 
 
Data Analysis: 
Unless otherwise indicated, all testing of statistical significance will be two-sided, and a 
difference resulting in a p-value of less than or equal to 0.05 will be considered statistically 
significant. Also, after each analysis, General Linear Models (GLM) will be used to control for 
possible confounders, including BMI, gender, age and ethnicity. 
 
References: 
[1] 
A. Sull, S. Inceoglu, A. August, S. Gregorius, and M. D. Wongworawat, “Comparison of 
Barbed Sutures in Porcine Flexor Tenorrhaphy,” HAND, vol. 11, no. 4, pp. 475–478, 
Dec. 2016. 
[2] 
P. J. Regier, D. D. Smeak, and K. C. McGilvray, “Security and biomechanical strength of 
three end-pass configurations for the terminal end of intradermal closures performed with 
unidirectional barbed suture material in dogs,” Am. J. Vet. Res., vol. 77, no. 12, pp. 1392–
1400, Dec. 2016. 
[3] 
P. M. Parikh, S. P. Davison, and J. P. Higgins, “Barbed Suture Tenorrhaphy: An Ex Vivo 
Biomechanical Analysis,” Plast. Reconstr. Surg., vol. 124, no. 5, pp. 1551–1558, Nov. 
2009. 
[4] 
A. M. Trocchia, H. N. Aho, and G. Sobol, “A Re-Exploration of the Use of Barbed 
Sutures in Flexor Tendon Repairs,” Orthopedics, vol. 32, no. 10, pp. 731–735, Oct. 2009. 
[5]  
Stephens S, Politi J, Taylor BC. Evaluation of Primary Total Knee Arthroplasty Incision 
Closure with the Use of Continuous Bidirectional Barbed Suture. Surg Technol Int. 2011 

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Dec;21:199–203.  
[6]  
Smith EL, DiSegna ST, Shukla PY, Matzkin EG. Barbed versus traditional sutures: 
closure time, cost, and wound related outcomes in total joint arthroplasty. J Arthroplasty. 
2014 Feb;29(2):283–7.  
[7]  
Giampaolino P, De Rosa N, Tommaselli GA, Santangelo F, Nappi C, Sansone A, et al. 
Comparison of bidirectional barbed suture Stratafix and conventional suture with  
intracorporeal 
knots 
in 
laparoscopic 
myomectomy 
by 
office 
transvaginal 
hydrolaparoscopic follow-up: a preliminary report. Eur J Obstet Gynecol Reprod Biol. 
2015 Dec;195:146–50.