Wounds and Injuries
Conditions
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
wound closure device
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 3-month | Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time of procedure | immediately | Time it takes to use device |
Countries
United States