NCT03305887

Brief Summary

A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

January 13, 2017

Results QC Date

November 18, 2019

Last Update Submit

December 27, 2019

Conditions

Wound Closure

Keywords

TKABarbed sutureSurgical time

Outcome Measures

Primary Outcomes (1)

  • Suturing Time

    The total time required to close the surgical incisions between treatment groups.

    During Surgery

Study Arms (2)

Barbed suture group

EXPERIMENTAL

The deep layer and the intermediate layer will be repaired and closed by using one "STRATAFIX™ Symmetric" Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.

Device: "STRATAFIX™ Symmetric" Knotless TissueDevice: "STRATAFIX Spiral" suturesDevice: DERMABOND™ Advance™ Skin Closure System

Conventional suture group

ACTIVE COMPARATOR

VICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.

Device: VICRYL® PLUSDevice: "STRATAFIX Spiral" suturesDevice: DERMABOND™ Advance™ Skin Closure System

Interventions

"STRATAFIX™ Symmetric" Knotless TissueDEVICE

This devices will be used in deep and intermediate layers of barbed suture group.

Also known as: STRATAFIX Symmetric
Barbed suture group
VICRYL® PLUSDEVICE

This devices will be used in deep and intermediate layers of conventional suture group.

Also known as: Polyglactin 910
Conventional suture group
"STRATAFIX Spiral" suturesDEVICE

This devices will be used in intradermal layer of both barbed suture and conventional suture group.

Also known as: Spiral
Barbed suture groupConventional suture group
DERMABOND™ Advance™ Skin Closure SystemDEVICE

This devices will be used in skin layer of both barbed suture and conventional suture group.

Also known as: DERMABOND
Barbed suture groupConventional suture group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is ≥ 18 years and \< 80 years of age;
  • Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;
  • Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and
  • Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete.

You may not qualify if:

  • Female patient who is pregnant or lactating at the time of screening;
  • Patient has a Body Mass Index (BMI) \> 40 kg/m2;
  • Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid);
  • Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology;
  • Patient has had previous open surgeries on the affected joint other than arthroscopy;
  • Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing;
  • Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®\* MP) or D\&C Violet No. 2;
  • Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) ≥ 10.0 mmol/L;
  • Patient has a history of immunosuppressive drug use, including steroids, within the last 6 months;
  • Patient has undergone chemotherapy or radiation within the last 6 months prior to study enrollment or is scheduled to do so during the study period;
  • Patient has known personal or family history of keloid formation or hypertrophy;
  • Patient has other dermatologic conditions known to impair wound healing;
  • Patient is participating in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study;
  • Patient has any physical or psychological condition which would impair study participation; and
  • Patient is judged unsuitable for study participation by the investigator for any other reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100000, China

Location

NanFang Hospital

Guangzhou, Guangdong, 510000, China

Location

Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&technology

Wuhan, Hubei, 430000, China

Location

Jiangsu province hospital

Nanjing, Jiangsu, 210000, China

Location

Jilin University Chinese Japanese Friendship Hospital

Changchun, Jilin, 130033, China

Location

second affiliated hospital of Xi'an Jiaotong university

Xi’an, Shanxi, 710004, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Results Point of Contact

Title
Xiaolei, Wang
Organization
Johnson & Johnson Medical Shanghai Ltd.
xwang183@its.jnj.com
+86 21 33378749

Study Officials

  • Patty Schleckser

    Ethicon, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

October 10, 2017

Study Start

June 12, 2017

Primary Completion

April 13, 2018

Study Completion

May 21, 2018

Last Updated

January 13, 2020

Results First Posted

January 13, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)