Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty

Zipline Medical

Status: Completed

Conditions: Wound Healing; Arthroplasty, Knee Replacement

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02460172

006

Details and patient eligibility

About

Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.

Full description

Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients 18 years of age and older
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

1. Known bleeding disorder not caused by medication
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Zip Surgical Skin Closure

Active Comparator group

Description:

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.

Treatment:

Device: Zip Surgical Skin Closure

Steel Staples

Active Comparator group

Description:

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.

Treatment:

Device: Steel Staples