Child Delivery Using an Elective C- SectionPhase 2/3NCT01709240
Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
A Phase 2/3 study testing BioWeld1 System in people with Child Delivery Using an Elective C- Section, run by IonMed Ltd at 1 site in Israel.
Trial summary
The purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Child Delivery Using an Elective C- Section
- What is being tested?
- BioWeld1 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 to 40 years old.
- Women scheduled for child delivery using an elective C- section.
- Women in their first or second pregnancy having a C-section for the first time
- Healthy women with no systemic diseases such as diabetes, heart disease etc.
- Women with average weight, BMI prior pregnancy of 18.5-25.
- Women with no skin diseases
Show all 23Show fewer
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- The subject commits to return for the scheduled post-operative follow-up visits at the clinic
- General Exclusion Criteria:
- Women intended for any abdominal surgery other than C-section procedure
- Women intended for C-section procedure for other purpose than child delivery
- Any prior C-section procedure for any purpose
- Women Received/Receiving radiotherapy or chemotherapy of any kind.
- Women receiving steroids or any other medication that interferes with wound healing.
- Women receiving Acutan in the last half year.
- Women with bleeding diathesis or hypercoagulable state.
- Women with prior cosmetic or medical treatment in the target area (e.g. phosphatydilcholine injections).
- Women suffering from Thrombocytopenia (platelets count<100,000/mm3) pre-procedure.
- Women who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
- Psychiatric background.
- Intra operative exclusion criteria:
- Severe excessive bleeding from the wound
- Patient is not eligible for an experimental closure according to the physician discretion.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah University Hospital, Mount Scopus
Jerusalem, Israel, 91240
About this study
The purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure.
Read the detailed description
In every surgical procedure, there is a need to close the incision that was made. Current methods for incision closure include stitching, gluing and stapling. Some of these methods are time consuming, have potential for infection and may leave a significant scar. The bioWeld1 technology suggests a new approach for incision closure. It is a novel medical device that consists of a Chitosan film and the BioWeld1 plasma ejecting device. The Chitosan film is intended to be applied to the skin incision, while the BioWeld1device is used for welding the Chitosan to the skin by means of cold plasma technology.
- Being tested
- BioWeld1 System
- Keywords
- Chitosan, Plasma, Incision Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioWeld1 SystemDevice
External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.
| Study group | Role | What they receive |
|---|---|---|
| BioWeld1 System | Experimental | Not described Receives: Device: BioWeld1 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
Measured: Within 21 days post procedure
Secondary outcomes (1)
Performance
The following secondary variables will be examined:
- Complete epidermal closure.
- Redness and edemas grade <1 in at least 87% of the subjects.
- Encrustation grade <1 in at least 87% of the subjects.
- Discharge from wound is negative in at least 87% of the subjects.
- Photographic evidence of clean healing in at least 30% of the cases.
Measured: At 21 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: Internal decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Delivery Using an Elective C- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IonMed Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Drorit Hochner-Celnikier, MD, Principal investigator, Hadassah University Hospital, Mount Scopus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709240
- Sponsor's protocol ID
- BW102
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2012
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
- ClinicalTrials.gov ID
- NCT01709240
- Acronym / sponsor ID
- BW102
- Keywords
- Chitosan, Plasma, Incision Closure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IonMed LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 18 Oct 2012 (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 purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure.
Detailed description
In every surgical procedure, there is a need to close the incision that was made. Current methods for incision closure include stitching, gluing and stapling. Some of these methods are time consuming, have potential for infection and may leave a significant scar. The bioWeld1 technology suggests a new approach for incision closure. It is a novel medical device that consists of a Chitosan film and the BioWeld1 plasma ejecting device. The Chitosan film is intended to be applied to the skin incision, while the BioWeld1device is used for welding the Chitosan to the skin by means of cold plasma technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioWeld1 System | Experimental | Device: BioWeld1 System |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Age between 20 to 40 years old.
- Women scheduled for child delivery using an elective C- section.
- Women in their first or second pregnancy having a C-section for the first time
- Healthy women with no systemic diseases such as diabetes, heart disease etc.
- Women with average weight, BMI prior pregnancy of 18.5-25.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BioWeld1 SystemExternal skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure. | Device | BioWeld1 System |
Primary outcome
Safety
Time frame: Within 21 days post procedure
Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
1 secondary outcome
Performance
Time frame: At 21 days post procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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.
Drorit Hochner-Celnikier, MD principal investigator
Hadassah University Hospital, Mount Scopus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BioWeld1 System in people with Child Delivery Using an Elective C- Section, run by IonMed Ltd 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 23 inclusion and 0 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: withdrawn, as of the sponsor's last update on 27 Mar 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Within 21 days post procedure). 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 27 Mar 2015.