Symmetric on Total Knee Arthroplasty (TKA)

Wound Closure Clinical Trial

— SFX  

Official title:

A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305887
• Other study ID #: ESC-16-001
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: December 2019
• Source: Johnson & Johnson Medical, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

The primary objective of this prospective, randomized controlled study is to evaluate the wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as the total time required to close the surgical incisions in patients undergoing TKA procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary objectives will include the evaluation of differences in overall surgical procedure time, operating room (OR) time, length of stay, procedure costs, quality of life measures including pain, and range of motion (ROM). In addition, the difference in the safety profiles for both wound closure procedures will be evaluated through the analysis of the incidence of wound complications including dehiscence, wound infections, and other adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 21, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Patient is = 18 years and < 80 years of age;

2. Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;

3. Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and

4. Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete.

Exclusion Criteria:

1. Female patient who is pregnant or lactating at the time of screening;

2. Patient has a Body Mass Index (BMI) > 40 kg/m2;

3. Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid);

4. Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology;

5. Patient has had previous open surgeries on the affected joint other than arthroscopy;

6. Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing;

7. Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®* MP) or D&C Violet No. 2;

8. Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) = 10.0 mmol/L;

9. Patient has a history of immunosuppressive drug use, including steroids, within the last 6 months;

10. 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;

11. Patient has known personal or family history of keloid formation or hypertrophy;

12. Patient has other dermatologic conditions known to impair wound healing;

13. Patient is participating in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study;

14. Patient has any physical or psychological condition which would impair study participation; and

15. Patient is judged unsuitable for study participation by the investigator for any other reason.

Related Conditions & MeSH terms

• Wound Closure

Intervention

Device:
• "STRATAFIX™ Symmetric" Knotless Tissue
This devices will be used in deep and intermediate layers of barbed suture group.
• VICRYL® PLUS
This devices will be used in deep and intermediate layers of conventional suture group.
• "STRATAFIX Spiral" sutures
This devices will be used in intradermal layer of both barbed suture and conventional suture group.
• DERMABOND™ Advance™ Skin Closure System
This devices will be used in skin layer of both barbed suture and conventional suture group.

Locations

Country	Name	City	State
China	Chinese PLA general hospital	Beijing	Beijing
China	Jilin University Chinese Japanese Friendship Hospital	Changchun	Jilin
China	NanFang Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jiangsu province hospital	Nanjing	Jiangsu
China	Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&technology	Wuhan	Hubei
China	second affiliated hospital of Xi'an Jiaotong university	Xi'an	Shanxi

Sponsors (8)

Lead Sponsor	Collaborator
Johnson & Johnson Medical, China	China-Japan Union Hospital, Jilin University, Chinese PLA General Hospital, Nanfang Hospital of Southern Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suturing Time	The total time required to close the surgical incisions between treatment groups.	During Surgery