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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.
Hadassah University Hospital, Mount Scopus
Jerusalem, Israel, Israel
Safety
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
Performance
The following secondary variables will be examined: 1. Complete epidermal closure. 2. Redness and edemas grade \<1 in at least 87% of the subjects. 3. Encrustation grade \<1 in at least 87% of the subjects. 4. Discharge from wound is negative in at least 87% of the subjects. 5. Photographic evidence of clean healing in at least 30% of the cases.
Time frame: At 21 days post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.