N/A
N=184
Symmetric on Total Knee Arthroplasty (TKA)
Wound Closure
Bottom Line
View on ClinicalTrials.gov: NCT03305887 ↗Enrolled (actual)
184
Serious AEs
2.8%
Results posted
Jan 2020
Primary outcome: Primary: Suturing Time — 15.516; 20.864 minuts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- "STRATAFIX™ Symmetric" Knotless Tissue (Device); VICRYL® PLUS (Device); "STRATAFIX Spiral" sutures (Device); DERMABOND™ Advance™ Skin Closure System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Medical, China
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suturing Time |
15.516; 20.864 | — |
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)
Eligibility Criteria
Inclusion Criteria
- Patient is ≥ 18 years and 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.
Data sourced from ClinicalTrials.gov (NCT03305887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.