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Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System

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ClinicalTrials.gov Identifier: NCT00521755
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : June 9, 2011
Sponsor:
Information provided by:
Seraffix

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.

Condition or disease Intervention/treatment Phase
Dehiscence, Surgical Wound Device: Seraffix LTB Not Applicable

Detailed Description:

Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. The purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces.

Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. There have been two fundamental approaches to laser assisted bonding of tissues:

  1. Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
  2. Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue).

Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
Study Start Date : December 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : February 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Device: Seraffix LTB
laser soldering for soft tissue wounds


Outcome Measures
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Primary Outcome Measures :
  1. Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 1. Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0). 2. Wound dehiscence of at least 50% of wound length: [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/Female age 18-60.
  • Subject is scheduled for laparoscopic cholecystectomy surgery.
  • Subject able to comprehend and give informed consent for participation in this study.
  • Signed informed consent form.

Exclusion Criteria:

  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
  • Acute infection requiring intravenous antibiotics at the time of screening.
  • Bleeding, coagulation and or clotting disorders.
  • Diabetes mellitus: IDDM or NIDDM.
  • HIV positive or any other immunosuppressive disorder.
  • Renal failure (Serum creatinine >2.0 mg/dl).
  • Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.
  • Any concomitant infection - viral or bacterial.
  • Drug abuse.
  • Use of steroids.
  • Infection / abscess / pain in treatment target area.
  • Pregnancy or lactating.
  • History of keloid scarring.
  • Use of aspirin or antioxidants
  • Subject is suffering extreme general weakness.
  • Subject objects to the study protocol.
  • Known cognitive or psychiatric disorder
  • Concurrent participation in any other clinical study.
  • Physician objection.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521755


Locations
Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
Seraffix
Investigators
Principal Investigator: Ossama Hatoum, Dr. HaEmek Medical Center, Israel
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, Seraffix
ClinicalTrials.gov Identifier: NCT00521755     History of Changes
Other Study ID Numbers: SF-01
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2009

Keywords provided by Seraffix:
Laser bonding soft tissue albumin

Additional relevant MeSH terms:
Surgical Wound
Surgical Wound Dehiscence
Wounds and Injuries
Postoperative Complications
Pathologic Processes