Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
NCT ID: NCT02460172
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2015-05-31
2017-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zip Surgical Skin Closure
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure
Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Steel Staples
Skin closure device for the closure of the skin layer following surgical incision
Interventions
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Zip Surgical Skin Closure
Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples
Skin closure device for the closure of the skin layer following surgical incision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
3. Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op
Exclusion Criteria
2. Known personal or family history of keloid formation or scar hypertrophy
3. Known allergy or hypersensitivity to non-latex skin adhesives
4. Atrophic skin deemed clinically prone to blistering
5. Any skin disorder affecting wound healing
6. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
18 Years
ALL
Yes
Sponsors
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ZipLine Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rodney Benner, MD
Role: PRINCIPAL_INVESTIGATOR
Study Center
Locations
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Shelbourne Knee Center
Indianapolis, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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006
Identifier Type: -
Identifier Source: org_study_id
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