Prospective Randomized Trial of Stratafix vs. Vicryl in Total Hip Arthroplasty.
Wound; Hip
About this trial
This is an interventional treatment trial for Wound; Hip focused on measuring barbed suture, knoteless suture, closure, wound, time, total hip arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Able to fluently speak and understand the local language
- If female, is non-pregnant (negative pregnancy test results at the baseline/randomization visit) and non-lactating.
- End-stage osteoarthritis patients planning to undergo primary total hip arthroplasty
- BMI less than 40 kg/m2
Exclusion Criteria:
- BMI greater than or equal to 40 kg/m2.
- History of known bleeding disorder.
- History of medical co-morbidity that may result in poor wound healing (i.e. diabetes mellitus, peripheral vascular disease).
- Patients <18 or >80 years of age.
- Patients who are prisoners.
- Mentally unable to sign informed consent.
- Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
STRATAFIX GROUP
CONTROL GROUP
For the active arm of the study, wound closure will be performed similarly in 3 layers with the use of barbed equivalents at every layer: STRATIFIX symmetric PDS Plus #1 will be used to close the deep fascia and muscles . The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue
For the control arm of the study, wound closure will be performed similarly in 3 layers with the use of vicryl to closure the deep fascia and muscles. The subcutaneous fat layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and glue