Child Delivery Using an Elective C- Section Clinical Trial
Official title:
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility |
Inclusion Criteria: 1. Age between 20 to 40 years old. 2. Women scheduled for child delivery using an elective C- section. 3. Women in their first or second pregnancy having a C-section for the first time 4. Healthy women with no systemic diseases such as diabetes, heart disease etc. 5. Women with average weight, BMI prior pregnancy of 18.5-25. 6. Women with no skin diseases 7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. 8. The subject commits to return for the scheduled post-operative follow-up visits at the clinic General Exclusion Criteria: 1. Women intended for any abdominal surgery other than C-section procedure 2. Women intended for C-section procedure for other purpose than child delivery 3. Any prior C-section procedure for any purpose 4. Women Received/Receiving radiotherapy or chemotherapy of any kind. 5. Women receiving steroids or any other medication that interferes with wound healing. 6. Women receiving Acutan in the last half year. 7. Women with bleeding diathesis or hypercoagulable state. 8. Women with prior cosmetic or medical treatment in the target area (e.g. phosphatydilcholine injections). 9. Women suffering from Thrombocytopenia (platelets count<100,000/mm3) pre-procedure. 10. Women who is currently participating or have participated in an investigational study, other than this study, within the past 60 days. 11. Psychiatric background. Intra operative exclusion criteria: 1. Severe excessive bleeding from the wound 2. Patient is not eligible for an experimental closure according to the physician discretion. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah University Hospital, Mount Scopus | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| IonMed Ltd |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound). | Within 21 days post procedure | Yes |
| Secondary | 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. |
At 21 days post procedure | Yes |