ZIPS Study - Zip Incision aPproximation vs. Suture

NCT02213510 | Completed Results

• 1 other identifier: 140718
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound; Cardiac Arrhythmia

Keywords

pacemaker; implantable cardioverter defibrillator; ICD; surgical wound closure; sutures; Zipline; Zips; CIED; cardiovascular implantable electronic devices; arrhythmia

Outcome Measures

Primary Outcomes (2)

• Overall Closure Time

  Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)

  2 weeks

• Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)

  Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).

  3 Months

Secondary Outcomes (9)

• Surgeon Wound Evaluation Scale (WES)

  2 weeks

• Surgeon Evaluation Based on the Wound Evaluation Scale (WES)

  3 Months

• Surgeon Satisfaction With Scar

  3 months

• Patient Comfort

  2 weeks

• Patient Satisfaction With Scar

  3 months

Study Arms (2)

Zip Surgical Skin Closure device

EXPERIMENTAL

The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.

Device: Zip Surgical Skin Closure Device

Standard Suture Closure

ACTIVE COMPARATOR

The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Device: Standard Suture Closure

Interventions

Zip Surgical Skin Closure Device DEVICE

The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.

Also known as: Wound closure device

Zip Surgical Skin Closure device

Standard Suture Closure DEVICE

The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Standard Suture Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• ZipLine Medical Inc.: collaborator

Study Sites (1)

UCSD Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Related Links

• ZipLine Medical Website

MeSH Terms

Conditions

Wounds and Injuries; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ulrika Birgersdotter-Green, MD
• Organization: UC San Diego School of Medicine

ubgreen@ucsd.edu

858-657-5310

Study Officials

• Ulrika Birgersdotter-Green, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 30, 2016
• Results First Posted: May 30, 2016

Record last verified: 2016-05

Locations

US (1)