Arthroplasty, Replacement, Knee
Conditions
Keywords
Bi lateral knee surgery, uni compartmental
Brief summary
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.
Detailed 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.
Interventions
Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
DEVICESteel Staples
Skin Closure device for the closure of the skin layer for surgical incisions.
Sponsors
ZipLine Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Outcome - Wound Healing | 6 weeks post surgery | Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction with the Closure Method | At Discharge, 1-3 days post surgery | Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) |
| Patient Pain | Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.) | General post operative and incisional pain levels will be collected using a 10 point VAS scale |
| Patient Satisfaction of Scars | At 6 week Follow up (exit) visit | Scar satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) and with a 10 point VAS scale |
Countries
United States
Outcome results
None listed