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.

Study Overview

• Status: Withdrawn
• Conditions: Child Delivery Using an Elective C- Section
• Intervention / Treatment: Device: BioWeld1 System

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91240
    • Hadassah University Hospital, Mount Scopus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IonMed Ltd
• Investigators: Principal Investigator: Drorit Hochner-Celnikier, MD, Hadassah University Hospital, Mount Scopus

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2013
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (ESTIMATE): October 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Plasma; Chitosan; Incision Closure
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: BW102