Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure

NCT ID: NCT01709240

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Child Delivery Using an Elective C- Section

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BioWeld1 System

Group Type: EXPERIMENTAL

BioWeld1 System

Intervention Type: DEVICE

External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.

Interventions

BioWeld1 System

External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.

Intervention Type: DEVICE

Eligibility Criteria

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

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.

1. Severe excessive bleeding from the wound

2. Patient is not eligible for an experimental closure according to the physician discretion.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IonMed Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Drorit Hochner-Celnikier, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital, Mount Scopus

Locations

Hadassah University Hospital, Mount Scopus

Jerusalem, Israel, Israel

Countries

Israel

Other Identifiers

BW102

Identifier Type: -

Identifier Source: org_study_id