Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
|ClinicalTrials.gov Identifier: NCT01709240|
Recruitment Status : Withdrawn (Internal decision)
First Posted : October 18, 2012
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Child Delivery Using an Elective C- Section||Device: BioWeld1 System||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2014|
|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.
- 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).
- Performance [ Time Frame: At 21 days post procedure ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709240
|Hadassah University Hospital, Mount Scopus|
|Jerusalem, Israel, 91240|
|Principal Investigator:||Drorit Hochner-Celnikier, MD||Hadassah University Hospital, Mount Scopus|