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

This study is not yet open for participant recruitment.
Verified October 2012 by IonMed Ltd
Sponsor:
Information provided by (Responsible Party):
IonMed Ltd
ClinicalTrials.gov Identifier:
NCT01709240
First received: October 16, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Child Delivery Using an Elective C- Section
 Device: BioWeld1 System
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by IonMed Ltd:

Primary Outcome Measures:
  • Safety [ Time Frame: Within 21 days post procedure ] [ Designated as safety issue: Yes ]
    Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).


Secondary Outcome Measures:
  • Performance [ Time Frame: At 21 days post procedure ] [ Designated as safety issue: Yes ]

    The following secondary variables will be examined:

    1. Complete epidermal closure.
    2. Redness and edemas grade <1 in at least 87% of the subjects.
    3. Encrustation grade <1 in at least 87% of the subjects.
    4. Discharge from wound is negative in at least 87% of the subjects.
    5. Photographic evidence of clean healing in at least 30% of the cases.


Estimated Enrollment: 32
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709240

Contacts
Contact: Yaara Yarmut, DVM +972-4-9591393 yaara.yarmut@gmail.com

Locations
Israel
Hadassah University Hospital, Mount Scopus
Jerusalem, Israel, 91240
Sponsors and Collaborators
IonMed Ltd
Investigators
Principal Investigator: Drorit Hochner-Celnikier, MD Hadassah University Hospital, Mount Scopus
  More Information

No publications provided

Responsible Party: IonMed Ltd
ClinicalTrials.gov Identifier: NCT01709240     History of Changes
Other Study ID Numbers: BW102
Study First Received: October 16, 2012
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by IonMed Ltd:
Chitosan
Plasma
Incision Closure

ClinicalTrials.gov processed this record on May 19, 2013