C.Surgical Procedure; Dehiscence, Cesarean SectionZIPS-CNCT02915952
Zip Incision Approximation vs. Suture for C-Section
A study testing Zip Surgical Skin Closure Device and Conventional Sutures in people with C.Surgical Procedure; Dehiscence, Cesarean Section, run by ZipLine Medical Inc. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- C.Surgical Procedure; Dehiscence, Cesarean Section
- What is being tested?
- Zip Surgical Skin Closure Device and Conventional Sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients 18 years of age and older
- Primary C-section
- Patients willing and able to complete study protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
Elias Castel, MD, eliasary@gmail.com
Elias Castel, MD
About this study
Official title: 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.
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.
Read the detailed description
Cesarean-section birth is a very invasive surgical procedure. While the desired outcome focuses primarily on the successful delivery of a healthy baby and maintenance of the mother's health, the surgery involves a complex surgical closure process, starting with the uterus, and progressing through several layers of traditionally suture closure in several tissue planes. A successful closure results in no surgical site complications, with good patient comfort and a minimal scar being a desired outcome.
Conventional skin closure methods such as sutures are effective but have drawbacks. It has been suggested that the ideal method of wound / incision closure should be:
- fast
- non-traumatic
- minimally or non-invasive
- associated with a low incidence of adverse events such as dehiscence and infection
- yielding acceptable cosmetic results
ZipLine Medical, Inc. is a Campbell, California-based company that 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. In the USA, the device has been classified by the FDA as a Class I, 510(k) Exempt device and began commercial use in the USA in April 2013.
The ZipLine Device has been clinically demonstrated benefits include (references included later in this document):
- Closure speed faster/superior to (and less variable compared to) sutures
- Suture-like cosmetic outcome
- Reduction in post-surgical care costs
- Fewer closure-related wound issues
- Greater patient satisfaction
- Being tested
- Zip Surgical Skin Closure Device, Conventional Sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip Surgical Skin Closure DeviceDevice
Also called Zip
The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery
Conventional SuturesOther
Conventional Sutures will be used for surgical wound closure in C-Section Surgery
| Study group | Role | What they receive |
|---|---|---|
| Zip Closure Device | Active comparator | The Zip device is a non-invasive, single use, sterile medical device for closure of the skin layer for surgical incisions or laceration repair. Receives: Device: Zip Surgical Skin Closure Device |
| Conventional Sutures | Active comparator | Conventional subdermal (subcuticular) absorbable sutures Receives: Other: Conventional Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Procedure Closure
Upon closure of the Cesarean incision - Zip or Suture touches skin to close incision
Measured: 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
Measured: 3 months
Secondary outcomes (4)
Surgeon Closure Method Satisfaction
Satisfaction with closure method, scar appearance
Measured: Procedure, 3-5 days, 3 months
Patient Closure Method Satisfaction
Satisfaction with closure method, scar appearance
Measured: 3-5 days, 14 days, 3 months
Patient Pain and Discomfort by Subject Questionnaire
Pain associated with the closure method and level of discomfort during use will be asked by questionnaire
Measured: 3-5 days, 14 days, 3 months
Incidence and severity of Adverse Events
The incidence and severity of adverse events (AE) associated with Zip device and control will be evaluated
Measured: Procedure, 3-5 days, 14 days, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; Dehiscence, Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZipLine Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elias Castel, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915952
- Sponsor's protocol ID
- ZipsC-006
- Acronym
- ZIPS-C
- Status last verified
- Aug 2017
- First submitted
- 16 Sep 2016
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02915952
- Acronym / sponsor ID
- ZIPS-C / ZipsC-006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ZipLine Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cesarean-section birth is a very invasive surgical procedure. While the desired outcome focuses primarily on the successful delivery of a healthy baby and maintenance of the mother's health, the surgery involves a complex surgical closure process, starting with the uterus, and progressing through several layers of traditionally suture closure in several tissue planes. A successful closure results in no surgical site complications, with good patient comfort and a minimal scar being a desired outcome.
Conventional skin closure methods such as sutures are effective but have drawbacks. It has been suggested that the ideal method of wound / incision closure should be:
- fast
- non-traumatic
- minimally or non-invasive
- associated with a low incidence of adverse events such as dehiscence and infection
- yielding acceptable cosmetic results
ZipLine Medical, Inc. is a Campbell, California-based company that 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. In the USA, the device has been classified by the FDA as a Class I, 510(k) Exempt device and began commercial use in the USA in April 2013.
The ZipLine Device has been clinically demonstrated benefits include (references included later in this document):
- Closure speed faster/superior to (and less variable compared to) sutures
- Suture-like cosmetic outcome
- Reduction in post-surgical care costs
- Fewer closure-related wound issues
- Greater patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zip Closure Device | Active comparator | Device: Zip Surgical Skin Closure DeviceThe 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 comparator | Other: Conventional SuturesConventional subdermal (subcuticular) absorbable sutures |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients 18 years of age and older
- Primary C-section
- Patients willing and able to complete study protocol
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zip Surgical Skin Closure DeviceAlso: ZipThe Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery | Device | Zip Closure Device |
| Conventional SuturesConventional Sutures will be used for surgical wound closure in C-Section Surgery | Other | Conventional Sutures |
Primary outcome
Time of Procedure Closure
Time frame: Procedure Closure - Zip or Suture touches skin until skin is closed
Upon closure of the Cesarean incision - Zip or Suture touches skin to close incision
Cosmetic Visual Analogue Scale (CVAS)
Time frame: 3 months
100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance
4 secondary outcomes
Surgeon Closure Method Satisfaction
Time frame: Procedure, 3-5 days, 3 months
Patient Closure Method Satisfaction
Time frame: 3-5 days, 14 days, 3 months
Patient Pain and Discomfort by Subject Questionnaire
Time frame: 3-5 days, 14 days, 3 months
Incidence and severity of Adverse Events
Time frame: Procedure, 3-5 days, 14 days, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Castel, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zip Surgical Skin Closure Device and Conventional Sutures in people with C.Surgical Procedure; Dehiscence, Cesarean Section, run by ZipLine Medical Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy M Winters (408-506-1866, wwinters0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Procedure Closure (time frame: Procedure Closure - Zip or Suture touches skin until skin is closed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.