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ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03201536
Acronym
ZIPS3
Enrollment
0
Registered
2017-06-28
Start date
2012-10-31
Completion date
2012-10-31
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and Injuries

Keywords

ZipLine3 device vs. conventional sutures

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.

Interventions

Sutures

DEVICEZip3

wound closure device

Sponsors

ZipLine Medical Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Wound healing3-monthWound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale

Secondary

MeasureTime frameDescription
time of procedureimmediatelyTime it takes to use device

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026