ZIPS Study - Zip Incision Approximation vs. STAPLE
This trial is active, not recruiting.
|Condition||arthroplasty, replacement, knee|
|Treatments||zip surgical skin closure, steel staples|
|Sponsor||ZipLine Medical Inc.|
|Start date||September 2014|
|End date||August 2015|
|Trial size||25 participants|
|Trial identifier||NCT02255877, 005|
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Effectiveness Outcome - Wound Healing
time frame: 6 weeks post surgery
Surgeon Satisfaction with the Closure Method
time frame: At Discharge, 1-3 days post surgery
time frame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
Patient Satisfaction of Scars
time frame: At 6 week Follow up (exit) visit
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty; - Patients willing to be evaluated at discharge and 6-weeks post op. Exclusion Criteria: - Known bleeding disorder not caused by medication - Known personal or family history of keloid formation or scar hypertrophy - Known allergy or hypersensitivity to non-latex skin adhesives - Atrophic skin deemed clinically prone to blistering - Any skin disorder affecting wound healing - Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
|Official title||A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty|
|Description||This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.|
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