N/A
N=40
ZIPS Study - Zip Incision aPproximation vs. Suture
Wound · Cardiac Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT02213510 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Overall Closure Time — 78; 216 seconds — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zip Surgical Skin Closure Device (Device); Standard Suture Closure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Closure Time |
78; 216 | <0.001 sig |
| PRIMARY Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale) |
35.8; 40.6 | 0.655 |
| SECONDARY Surgeon Wound Evaluation Scale (WES) |
5.82; 5.78 | 0.811 |
| SECONDARY Surgeon Evaluation Based on the Wound Evaluation Scale (WES) |
6; 6 | 1.00 |
| SECONDARY Surgeon Satisfaction With Scar |
1; 1.06 | 0.462 |
| SECONDARY Patient Comfort |
1.77; 1.94 | 0.646 |
| SECONDARY Patient Satisfaction With Scar |
1.32; 1.22 | 0.510 |
| SECONDARY Patient Rating of Scar |
0.87; 1.04 | 0.651 |
| SECONDARY Patient Incision Pain |
0.27; 0.27 | 1.00 |
| SECONDARY Patient Incision Pain |
0.27; 0.27 | 1.00 |
| SECONDARY Patient Incision Pain |
0.27; 0.27 | 1.00 |
Summary
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin Closure to standard sutures in patients undergoing cardiovascular implantable electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting scar, and overall cosmetic appearance of scar. The study will be following participants for 3 months following CIED procedure.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age and older;
- Patients requiring suture closure for epidermal closure (after placement of cardiac implantable electronic devices; including de novo and re implant generator changes);
- Patients willing and able to complete study protocol
- Life expectancy greater than 1 year
Exclusion Criteria
- Known bleeding disorder not caused by medication;
- Known personal or family history of keloid formation or scar hypertrophy;
- Known allergy or hypersensitivity to non-latex skin adhesives;
- Atrophic skin deemed clinically prone to blistering;
- Any skin disorder affecting wound healing;
- Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02213510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.