Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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Recruitment Status : Withdrawn (Internal decision)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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|