ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

Not Applicable

Withdrawn

• Conditions: Wounds and Injuries
• Interventions: Device: conventional Suture; Device: Zip3

• Registration Number: NCT03201536
• Lead Sponsor: ZipLine Medical Inc.

Brief Summary

Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

Detailed Description

The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.

Study Timeline

• Study First Submitted: 2012-05-21
• Study Start: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Study First Posted: 2017-06-28
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients between 18 and 75 years of age

   • In generally good health
   • Willing to be evaluated in 5-14 days and 3-months post op

2. Patient requiring a non-emergent skin incision or biopsy

   • Maximum excision size 1.5x3.0 cm
   • Requiring 4-0 or smaller suture for closure
   • In area of body trunk or extremities with low mobility and tension

Exclusion Criteria

1. Facial Incisions or incisions in high stress or tension areas
2. Previously diagnosed peripheral vascular disease
3. Insulin-dependent diabetes mellitus
4. Known bleeding diathesis
5. Known personal or family history of keloid formation or scar hypertrophy
6. Known allergy or hypersensitivity to adhesives
7. Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
8. Atrophic skin deemed clinically prone to blistering
9. Any skin disorder affecting wound healing
10. Incisions requiring dermal sutures
11. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sutures	conventional Suture	zipLine3 device verses conventional sutures
Zip3 Device	Zip3	-

Primary Outcome Measures

Name	Time	Method
Wound healing	3-month	Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale

Secondary Outcome Measures

Name	Time	Method
time of procedure	immediately	Time it takes to use device

Trial Locations

Locations (3)

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States

Plastic Surgery Institute of Northern California; 🇺🇸 San Francisco, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States