The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty

Launched by THE CLEVELAND CLINIC · Sep 15, 2017

Keywords

ClinConnect Summary

Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and deep tissue closures.\[1\], \[2\] In addition, barbed sutures have been shown to provide water-tight closure and wound strength comparable to or superior to closure with conventional sutures. Many comparative studies have been published contrasting barbed sutures to conventional closure techniques in multiple surgical fields. \[3\], \[4\] Various studies have evaluated the outcomes of different barbed suture devices, however there are no reports assessing the length of closure times using STRATAFIX (Ethico...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
• • 2. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
• • 3. Able to adhere to the study visit schedule and other protocol requirements.
• • 4. Able to fluently speak and understand the local language
• • 5. If female, is non-pregnant (negative pregnancy test results at the baseline/randomization visit) and non-lactating.
• • 6. End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty
• • 7. BMI less than 40 kg/m2
• Exclusion Criteria:
• • 1. BMI greater than or equal to 40 kg/m2.
• • 2. History of known bleeding disorder.
• • 3. History of medical co-morbidity that may result in poor wound healing (i.e. diabetes mellitus, peripheral vascular disease).
• • 4. Patients \<18 or \>80 years of age.
• • 5. Patients who are prisoners.
• • 6. Mentally unable to sign informed consent.
• • 7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.