Evaluation of the BioWeld1 System as a Method for Surgica... | NCT01709240

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

NCT01709240

Sponsor

IonMed Ltd

Status

Withdrawn

Last Update Posted

Mar 27, 2015Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Child Delivery Using an Elective C- Section

Interventions

BioWeld1 System

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Internal decision

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Oct 16, 2012

First Submission Date that Met QC Criteria

Oct 16, 2012

First Posted Date

Oct 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2015

Last Update Posted Date

Mar 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
BioWeld1 System	Experimental		Device: BioWeld1 System

Name	Type	Description	Arm Group Labels	Other Names
BioWeld1 System	Device	External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.	BioWeld1 System

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 20 to 40 years old.
Women scheduled for child delivery using an elective C- section.
Women in their first or second pregnancy having a C-section for the first time
Healthy women with no systemic diseases such as diabetes, heart disease etc.
Women with average weight, BMI prior pregnancy of 18.5-25.
Women with no skin diseases
Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
The subject commits to return for the scheduled post-operative follow-up visits at the clinic

General Exclusion Criteria:

Women intended for any abdominal surgery other than C-section procedure
Women intended for C-section procedure for other purpose than child delivery
Any prior C-section procedure for any purpose
Women Received/Receiving radiotherapy or chemotherapy of any kind.
Women receiving steroids or any other medication that interferes with wound healing.
Women receiving Acutan in the last half year.
Women with bleeding diathesis or hypercoagulable state.
Women with prior cosmetic or medical treatment in the target area (e.g. phosphatydilcholine injections).
Women suffering from Thrombocytopenia (platelets count<100,000/mm3) pre-procedure.
Women who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
Psychiatric background.

Intra operative exclusion criteria:

Severe excessive bleeding from the wound
Patient is not eligible for an experimental closure according to the physician discretion.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided