Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
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.
Child Delivery Using an Elective C- Section
Device: BioWeld1 System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure|
- Safety [ Time Frame: Within 21 days post procedure ] [ Designated as safety issue: Yes ]Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
- Performance [ Time Frame: At 21 days post procedure ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Experimental: BioWeld1 System||
Device: BioWeld1 System
External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709240
|Hadassah University Hospital, Mount Scopus|
|Jerusalem, Israel, 91240|
|Principal Investigator:||Drorit Hochner-Celnikier, MD||Hadassah University Hospital, Mount Scopus|