Wound Closure
Conditions
Keywords
TKA, Barbed suture, Surgical time
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)
Detailed 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.
Interventions
DEVICESTRATAFIX™ Symmetric Knotless Tissue
This devices will be used in deep and intermediate layers of barbed suture group.
DEVICEVICRYL® PLUS
This devices will be used in deep and intermediate layers of conventional suture group.
DEVICESTRATAFIX Spiral sutures
This devices will be used in intradermal layer of both barbed suture and conventional suture group.
DEVICEDERMABOND™ Advance™ Skin Closure System
This devices will be used in skin layer of both barbed suture and conventional suture group.
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
China-Japan Union Hospital, Jilin University
Nanfang Hospital, Southern Medical University
Tongji Hospital
Chinese PLA General Hospital
The First Affiliated Hospital with Nanjing Medical University
Johnson & Johnson Medical, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suturing Time | During Surgery | The total time required to close the surgical incisions between treatment groups. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| STRATAFIX Symmetric PDS Plus an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone) | 91 |
| Conventional Sutures Conventional Sutures is VICRYL Plus(Polyglactin 910) | 93 |
| Total | 184 |
Baseline characteristics
| Characteristic | STRATAFIX Symmetric PDS Plus | Conventional Sutures | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 56 Participants | 63 Participants | 119 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 30 Participants | 65 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 91 Participants | 93 Participants | 184 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 70 Participants | 68 Participants | 138 Participants |
| Sex: Female, Male Male | 21 Participants | 25 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 89 |
| other Total, other adverse events | 8 / 90 | 14 / 89 |
| serious Total, serious adverse events | 3 / 90 | 2 / 89 |
Outcome results
Primary
Suturing Time
The total time required to close the surgical incisions between treatment groups.
Time frame: During Surgery
Population: total 184 patients enrolled in this study, and 5 patients have no suture time, because they withdrawn from study before surgery or violated protocol, etc.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| STRATAFIX Symmetric PDS Plus | Suturing Time | 15.516 minuts |
| Conventional Sutures | Suturing Time | 20.864 minuts |