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

IonMed

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Child Delivery Using an Elective C- Section

Treatments: Device: BioWeld1 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01709240

BW102

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

BioWeld1 System

Experimental group

Treatment:

Device: BioWeld1 System