ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

Zipline Medical

Status: Withdrawn

Conditions: Wounds and Injuries

Treatments: Device: Zip3; Device: conventional Suture

Study type: Interventional

Funder types: Industry

Identifiers

NCT03201536

100-002-12

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

sutures

Active Comparator group

Description:

zipLine3 device verses conventional sutures

Treatment:

Device: conventional Suture

Zip3 Device

Active Comparator group

Treatment:

Device: Zip3