Zip Incision Approximation vs. Suture for C-Section
ZIPS-C
A Prospective, Non-blinded, Randomized Controlled Post-market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device Versus Sutures for Skin Closure in Subjects Who Undergo a Cesarean Section Procedure.
1 other identifier
interventional
60
1 country
1
Brief Summary
The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures when utilized for skin layer closure during wound closure of Cesarean Section Procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedAugust 4, 2017
August 1, 2017
1.3 years
September 16, 2016
August 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Time of Procedure Closure
Upon closure of the Cesarean incision - Zip or Suture touches skin to close incision
Procedure Closure - Zip or Suture touches skin until skin is closed
Cosmetic Visual Analogue Scale (CVAS)
100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance
3 months
Secondary Outcomes (4)
Surgeon Closure Method Satisfaction
Procedure, 3-5 days, 3 months
Patient Closure Method Satisfaction
3-5 days, 14 days, 3 months
Patient Pain and Discomfort by Subject Questionnaire
3-5 days, 14 days, 3 months
Incidence and severity of Adverse Events
Procedure, 3-5 days, 14 days, 3 months
Study Arms (2)
Zip Closure Device
ACTIVE COMPARATORThe Zip device is a non-invasive, single use, sterile medical device for closure of the skin layer for surgical incisions or laceration repair.
Conventional Sutures
ACTIVE COMPARATORConventional subdermal (subcuticular) absorbable sutures
Interventions
The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery
Conventional Sutures will be used for surgical wound closure in C-Section Surgery
Eligibility Criteria
You may qualify if:
- Patients 18 years of age and older
- Primary C-section
- Patients willing and able to complete study protocol
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
- Emergent C-Section
- Non-primary C-Section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, 52621, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Elias Castel, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2016
First Posted
September 27, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
August 4, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share