CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
"STRATAFIX™ Symmetric" Knotless Tissue +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03305887
NCT03305887N/ACompleted
CompareCT.gov

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)

Johnson & Johnson Medical, China·interventional·Posted Oct 10, 2017·Updated Jan 13, 2020

In Brief

A clinical study evaluating "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS, and 2 other interventions for Wound Closure. Completed, enrolled 184 participants across 7 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Closure
CountriesChina
CollaboratorsSecond 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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 10, 2017
Enrollment StartJun 12, 2017
Primary CompletionApr 13, 2018
Study CompletionMay 21, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.7 years ago

Interventions

"STRATAFIX™ Symmetric" Knotless Tissuedevice

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

VICRYL® PLUSdevice

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

"STRATAFIX Spiral" suturesdevice

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

DERMABOND™ Advance™ Skin Closure Systemdevice

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