Back to results

ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study (ZIPS3)

Primary Purpose

Wounds and Injuries

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

conventional Suture

Zip3

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring ZipLine3 device vs. conventional sutures

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
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:

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

Sites / Locations

Palo Alto Medical Foundation
Plastic Surgery Institute of Northern California
California Pacific Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

sutures

Zip3 Device

Arm Description

zipLine3 device verses conventional sutures

Outcomes

Primary Outcome Measures

Wound healing

Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale

Secondary Outcome Measures

time of procedure

Time it takes to use device

Full Information

NCT ID

NCT03201536

First Posted

May 21, 2012

Last Updated

June 26, 2017

Sponsor

ZipLine Medical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03201536

Brief Title

ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

Acronym

ZIPS3

Official Title

ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of enrollment

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZipLine Medical Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds and Injuries

Keywords

ZipLine3 device vs. conventional sutures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sutures

Arm Type

Active Comparator

Arm Description

zipLine3 device verses conventional sutures

Arm Title

Zip3 Device

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

conventional Suture

Other Intervention Name(s)

stitches,PeriStrips

Intervention Description

Sutures

Intervention Type

Device

Intervention Name(s)

Zip3

Intervention Description

wound closure device

Primary Outcome Measure Information:

Title

Wound healing

Description

Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale

Time Frame

3-month

Secondary Outcome Measure Information:

Title

time of procedure

Description

Time it takes to use device

Time Frame

immediately

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian M Parret, MD

Organizational Affiliation

Plastic Surgery Institute of Northern California

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Landon Clark, MD,MPH

Organizational Affiliation

Palo Alto Medical Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stanley P Leong, MD,FACS

Organizational Affiliation

California Pacific Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Palo Alto Medical Foundation

City

Palo Alto

State/Province

California

ZIP/Postal Code

94301

Country

United States

Facility Name

Plastic Surgery Institute of Northern California

City

San Francisco

State/Province

California

ZIP/Postal Code

94114

Country

United States

Facility Name

California Pacific Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

We'll reach out to this number within 24 hrs