ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

Study Overview
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Brief Summary
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Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

Detailed Description
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The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.

Official Title
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ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: conventional Suture
* Device: Zip3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 75 years of age In generally good health Willing to be evaluated in 5-14 days and 3-months post op Patient requiring a non-emergent skin incision or biopsy Maximum excision size 1.5x3.0 cm Requiring 4-0 or smaller suture for closure In area of body trunk or extremities with low mobility and tension Exclusion Criteria: Facial Incisions or incisions in high stress or tension areas Previously diagnosed peripheral vascular disease Insulin-dependent diabetes mellitus Known bleeding diathesis Known personal or family history of keloid formation or scar hypertrophy Known allergy or hypersensitivity to adhesives Presently taking steroids, immune stimulants, beta blockers, or anticoagulants Atrophic skin deemed clinically prone to blistering Any skin disorder affecting wound healing Incisions requiring dermal sutures Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sutures<br>zipLine3 device verses conventional sutures | Device: conventional Suture<br>* Sutures<br>* Other names: stitches,PeriStrips;|
| Active Comparator: Zip3 Device<br> | Device: Zip3<br>* wound closure device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of procedure | Time it takes to use device | immediately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ZipLine3 device vs. conventional sutures