ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

Wounds and Injuries Clinical Trial

— ZIPS3  

Official title:

ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03201536
• Other study ID #: 100-002-12
• Status: Withdrawn
• Phase: N/A
• First received: May 21, 2012
• Last updated: June 26, 2017
• Start date: October 2012
• Est. completion date: October 2012

Study information

• Verified date: June 2017
• Source: ZipLine Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• conventional Suture
Sutures
• Zip3
wound closure device

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	California Pacific Medical Center	San Francisco	California
United States	Plastic Surgery Institute of Northern California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
ZipLine Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale	3-month
Secondary	time of procedure	Time it takes to use device	immediately