ZIPS Study - Zip Incision Approximation vs. STAPLE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zip Surgical Skin Closure

Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples

Group Type ACTIVE_COMPARATOR

Zip Surgical Skin Closure

Intervention Type DEVICE

Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.

Steel Staples

Intervention Type DEVICE

Skin Closure device for the closure of the skin layer for surgical incisions.

Steel Staples

Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure

Group Type ACTIVE_COMPARATOR

Zip Surgical Skin Closure

Intervention Type DEVICE

Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.

Steel Staples

Intervention Type DEVICE

Skin Closure device for the closure of the skin layer for surgical incisions.

Interventions

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Zip Surgical Skin Closure

Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.

Intervention Type DEVICE

Steel Staples

Skin Closure device for the closure of the skin layer for surgical incisions.

Intervention Type DEVICE

Other Intervention Names

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Zip 16 Zip 8i

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No