Back to resultsEvaluation of the BioWeld1 System as a Method for Surgical Incision Closure
Primary Purpose
Child Delivery Using an Elective C- Section
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
BioWeld1 System
Sponsored by
About this trial
This is an interventional treatment trial for Child Delivery Using an Elective C- Section focused on measuring Chitosan, Plasma, Incision Closure
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Sites / Locations
- Hadassah University Hospital, Mount Scopus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BioWeld1 System
Arm Description
Outcomes
Primary Outcome Measures
Safety
Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01709240
Brief Title
Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
Official Title
Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Internal decision
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IonMed Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Delivery Using an Elective C- Section
Keywords
Chitosan, Plasma, Incision Closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioWeld1 System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BioWeld1 System
Intervention Description
External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.
Primary Outcome Measure Information:
Title
Safety
Description
Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
Time Frame
Within 21 days post procedure
Secondary Outcome Measure Information:
Title
Performance
Description
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.
Time Frame
At 21 days post procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drorit Hochner-Celnikier, MD
Organizational Affiliation
Hadassah University Hospital, Mount Scopus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital, Mount Scopus
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
We'll reach out to this number within 24 hrs