ZIPS Study - Zip Incision Approximation vs. STAPLE

Zipline Medical

Status and phase: Withdrawn; Phase 4

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Steel Staples; Device: Zip Surgical Skin Closure

Study type: Interventional

Funder types: Industry

Identifiers

NCT02255877

005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Zip Surgical Skin Closure

Active Comparator group

Description:

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

Treatment:

Device: Steel Staples

Device: Zip Surgical Skin Closure

Steel Staples

Active Comparator group

Description:

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

Treatment:

Device: Steel Staples

Device: Zip Surgical Skin Closure