ZIPS Study - Zip Incision Approximation vs. STAPLE

NCT02255877 | Withdrawn Phase 4

• 1 other identifier: 005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Bi lateral knee surgery; uni compartmental

Outcome Measures

Primary Outcomes (1)

• Effectiveness Outcome - Wound Healing

  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.

  6 weeks post surgery

Secondary Outcomes (3)

• Surgeon Satisfaction with the Closure Method

  At Discharge, 1-3 days post surgery

• Patient Pain

  Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)

• Patient Satisfaction of Scars

  At 6 week Follow up (exit) visit

Study Arms (2)

Zip Surgical Skin Closure

ACTIVE COMPARATOR

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

Device: Zip Surgical Skin Closure; Device: Steel Staples

Steel Staples

ACTIVE COMPARATOR

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

Device: Zip Surgical Skin Closure; Device: Steel Staples

Interventions

Zip Surgical Skin Closure DEVICE

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

Also known as: Zip 16, Zip 8i

Steel Staples; Zip Surgical Skin Closure

Steel Staples DEVICE

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

Steel Staples; Zip Surgical Skin Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ZipLine Medical Inc.: lead

Study Sites (1)

Orthopaedic Research Foundation

Indianapolis, Indiana, 46278, United States

Location

Study Officials

• Eric Storne

  VP Marketing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 3, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 24, 2016

Record last verified: 2016-10

Locations

US (1)