N/A N=25 Randomized Single-blind Treatment

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

Arthroplasty, Knee Replacement · Wound Healing

Bottom Line

View on ClinicalTrials.gov: NCT02460172 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcome: Primary: Incision Appearance / Scar Cosmesis — 1.3; 2.6; 1.9; 3.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Zip Surgical Skin Closure (Device); Steel Staples (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ZipLine Medical Inc.
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Incision Appearance / Scar Cosmesis	1.3; 2.6; 1.9; 3.3; 3.7; 4.8	—
SECONDARY Surgeon Closure Method Satisfaction	17; 5; 7; 17; 1; 3	—
SECONDARY Patient Pain - Incisional and General	1.8; 2.4; 1.4; 2.0; 0.7; 1.6	—
SECONDARY Surgeon and Patient Scar Satisfaction	17; 5; 7; 17; 1; 3	—
SECONDARY Range of Motion	109; 105; 122; 122	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Patients 18 years of age and older
Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02460172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.